<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>European Commission – Eisner Safety Consultants</title> <atom:link href="https://eisnersafety.com/tag/european-commission/feed/" rel="self" type="application/rss+xml" /> <link>https://eisnersafety.com</link> <description>Just another WordPress site</description> <lastBuildDate>Sun, 12 Jun 2022 18:04:29 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.7.1</generator> <item> <title>Notified Bodies Can do Remote Audits for MDR & IVDR</title> <link>https://eisnersafety.com/2021/02/03/notified-bodies-can-do-remote-audits-for-mdr-ivdr/?utm_source=rss&utm_medium=rss&utm_campaign=notified-bodies-can-do-remote-audits-for-mdr-ivdr</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Wed, 03 Feb 2021 15:11:42 +0000</pubDate> <category><![CDATA[EU Commission]]></category> <category><![CDATA[Feb 2021]]></category> <category><![CDATA[IVDR]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[Remote Auditing]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[MDR 2017/745]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[remote audit]]></category> <category><![CDATA[Remote Audits]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=6864</guid> <description><![CDATA[Notified bodies can now do remote audits for the MDR and IVDR — Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits & the period of time this will not be happening. So remote]]></description> <content:encoded><![CDATA[ <figure class="wp-block-image size-large"><img fetchpriority="high" decoding="async" width="1024" height="497" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/02/EU-Flags-for-Screen-1024x497.jpg" alt="" class="wp-image-46" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/02/EU-Flags-for-Screen-1024x497.jpg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/02/EU-Flags-for-Screen-600x291.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/02/EU-Flags-for-Screen-300x146.jpg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/02/EU-Flags-for-Screen-768x373.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/02/EU-Flags-for-Screen.jpg 1400w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure> <p>Notified bodies can now do remote audits for the MDR and IVDR — Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits & the period of time this will not be happening. So remote audits for these NBs won’t be happening immediately – but this is a big change! <a href="http://bit.ly/EUCommRemoteAuditNotice" target="_blank" rel="noreferrer noopener" aria-label=" (opens in a new tab)">EUR-Lex – 52021XC0111(01) –</a><a href="http://bit.ly/EUCommRemoteAuditNotice" target="_blank" rel="noreferrer noopener" aria-label=" (opens in a new tab)"> </a><a rel="noreferrer noopener" aria-label="EUR-Lex - 52021XC0111(01) - EN - EUR-Lex (opens in a new tab)" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOC_2021_008_R_0001" target="_blank">EN – EUR-Lex</a> Each Competent Authority will need to review each separate NB’s justifications and procedures separately and this is a COVID-19 exemption only so this is temporary. Once the Commission says COVID-19 crisis is over this goes away. </p> <p>Follow this discussion on <a rel="noreferrer noopener" aria-label=" (opens in a new tab)" href="https://www.linkedin.com/posts/leoeisnersafetyconsultants_eur-lex-52021xc011101-en-eur-lex-activity-6754512870802911232-mcp6" target="_blank">LinkedIn</a></p> ]]></content:encoded> </item> <item> <title>Standards Reconnaissance Subscription Service Coming Soon</title> <link>https://eisnersafety.com/2015/08/31/standards-reconnaissance-subscription-service-coming-soon/?utm_source=rss&utm_medium=rss&utm_campaign=standards-reconnaissance-subscription-service-coming-soon</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Mon, 31 Aug 2015 20:16:28 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[510(k)]]></category> <category><![CDATA[60601 series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1 3rd ed.]]></category> <category><![CDATA[AAMI]]></category> <category><![CDATA[AAMI ES60601-1]]></category> <category><![CDATA[Active Assisted Living]]></category> <category><![CDATA[Active Implantable Medical Devices Directive]]></category> <category><![CDATA[AIMDD]]></category> <category><![CDATA[ANSI/AAMI ES60601-1]]></category> <category><![CDATA[CDRH]]></category> <category><![CDATA[CENELEC]]></category> <category><![CDATA[Collateral Standard]]></category> <category><![CDATA[EN60601]]></category> <category><![CDATA[EN60601-1]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[FDA Guidance]]></category> <category><![CDATA[Home Healthcare Environments]]></category> <category><![CDATA[Home Use]]></category> <category><![CDATA[Home Use Environment]]></category> <category><![CDATA[Home Use Med Dvcs]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[IEC60601-1]]></category> <category><![CDATA[IEC60601-1 3rd ed.]]></category> <category><![CDATA[IEC60601-1-11]]></category> <category><![CDATA[ISO]]></category> <category><![CDATA[MDD]]></category> <category><![CDATA[MDD Amendment]]></category> <category><![CDATA[Medical]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Device Industry]]></category> <category><![CDATA[medical device regulators]]></category> <category><![CDATA[Medical Device Regulatory]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards database]]></category> <category><![CDATA[Standards db]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=4347</guid> <description><![CDATA[Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines? How much time does it take to put this list together and how much]]></description> <content:encoded><![CDATA[<p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><img decoding="async" class="alignleft size-medium wp-image-4348" src="http://www.eisnersafety.com/wp-content/uploads/2015/08/Stack-of-books-300x300.png" alt="Stack of books" width="300" height="300" />Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines? How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for your organization to keep up with all the different data sources we have the solution for you at a reasonable price. A Standards Reconnaissance Subscription Service to help medical electrical device manufacturers keep up to date on all the changes that occur for these documents so you are prepared for future changes well ahead of the norm and you are able to stay up to date on your list of standards. The focus of this service will be on the documents for <strong><u>medical electrical equipment & systems</u></strong> (MEE&S = IEC TC 62, SC 62A – 62D) and <strong><u>home use medical electrical equipment & systems</u></strong><u> (Home Use MEE&S = IEC Active Assisted Living System Committee (IEC AAL SyC) and any other Home Use medical electrical equipment documents from the IEC TC 62, SC 62A – 62D including IEC 60601-1-11 Home Use Environment)</u>.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">We plan to go live with the db by the end of Sept 2015.</span></p> <p><a href="#RSVP"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><u>Please reserve your spot</u></strong> by September 28, 2015 for this db subscription service.</span></a></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Some of the features will include [For Paid Subscribers unless noted otherwise]:</span></p> <ul> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Notification e-mails when changes occur (i.e. Change in transition information from FDA for a standard) and new records are entered into the db.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Receive either 2 or 4 reports per year (depending on Subscription level) summarizing:</span> <ul> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">key issues of that report cycle for MEE&S or home Use MEE&S,</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">estimated timeline for the publication of draft standards & other relevant documents of significance, and</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">full listing of all the documents in your part of the db with status information.</span></li> </ul> </li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Access to our searchable db (depending on Subscription level access to the either the MEE&S or Home Use MEE&S part of the db or the whole db) on our dedicated db website if you are a paid subscriber. [Limited access for free level of service with 10 – 15 standards (pre-defined)]</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Print out db search results the way you want them</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Export db search results for your use (limited by the terms & conditions of the db)</span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">There are several parts of this db [For Paid Subscribers unless noted otherwise]:</span></p> <ul> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Standards db – including information on the standards, technical reports, technical specifications, and publicly available specifications that are active or current, in draft or development which would include voting level documents such as New Work Proposals, Committee Drafts, etc., and withdrawn documents (The previous version of the active standard).</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">List of standards publishers & associated country (this will cover 50+ countries) [includes free service level],</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">List of Medical Device Regulators with their websites, if available, for a selection of countries including all the of EU & EFTA countries. We plan to expand this to include all countries in the world by the end of Stage 2 (below),</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Guidance Documents – Guidance documents that the regulatory bodies use for their national regulatory systems. Like for the US, Canada, & Europe. They will be added sometime after going live by end of stage 2 or 3 (see below).</span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Once the db goes live you can check out how the db works by accessing the free level of service to view a few examples of current standards (about 10 to 15). With the free service level you will be able to use most of the db features set other than obtaining reports, the update notification service, but you will not have access to List of Medical Device Regulators db of Guidance documents db.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Pricing starts at only:</span></p> <ul> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">$4,500/year for Base Entry Subscription (2 reports per year and select either MEE&S or Home Use MEE&S part of db),</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">$6,500/year for Mid-Level Subscription (4 reports per year and full access to db), or</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">$9,000/year & up for Premium Subscription (2 personalized reports for your company’s needs based on conversations with Leo Eisner, 2 reports per year from the Premium Subscription level, and full access to db)</span><br /> <span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">All payments to be paid in US$ only.</span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">We plan to go live with the db by the end of Sept 2015. Since we will be releasing the db in stages the early adopters will get a discount (20%) for the first annual subscription cycle and additionally we will throw in extra months to your subscription commensurate with how early you subscribe. The earlier you subscribe the more free months will be added to your first yearly subscription for no additional charge.</span><br /> <a name="RSVP"></a><br /> <span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><u>Please reserve your spot</u></strong> by September 28, 2015 for this db subscription service and to <strong><u>guarantee a discounted first year price and to obtain extra months added for free</u></strong>. To reserve your spot for the Base entry or the Mid-Level Subscriptions please arrange a $750.00 (US$) deposit and for the Premium Subscriptions please arrange a $1,500.00 (US$) deposit. Contact us to arrange for deposit.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">There will be a couple stages for the release of information for the db. We plan on continual updates over time to provide a really valuable resource and continually make it better. The first stage will be complete prior to the official release of the db which will include all the updated information for the IEC based MEE&S & Home Use MEE&S documents including updates on the small number of joint IEC/ISO documents. Stage 2 will be initiated just before the release of the db, which will include updates for the US, EU, and Canadian versions of the IEC & IEC/ISO MEE&S and Home Use MEE&S documents and IEC/ISO joint documents. We plan to have stage 2 completed around Jan 2016. Stage 3 will include updated information adding in the supporting medical device (non-medical-electrical) documents you need for your regulatory submissions such as ISO 10993 series of standards, ISO 15223-1, etc. This stage will initiate with the non-medical-electrical standards for IEC and ISO and in the future we will add other Standards Developers. We expect to start on stage 3 around Jan 2016 and have not yet scheduled it’s completion.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Please contact Leo Eisner to find out more details about this db. He can be reached by e-mail or phone at <a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a> and 503-244-6151 (Office) and 503-709-8328 (Cell).</span></p> ]]></content:encoded> </item> <item> <title>MDD Harmonized List of Standards Website Moves & Medical Device Sector Page Changes</title> <link>https://eisnersafety.com/2015/02/05/mdd-harmonized-list-of-standards-website-moves-medical-device-sector-page-changes/?utm_source=rss&utm_medium=rss&utm_campaign=mdd-harmonized-list-of-standards-website-moves-medical-device-sector-page-changes</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Thu, 05 Feb 2015 23:35:45 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[Active Implantable Medical Devices Directive]]></category> <category><![CDATA[AIMDD]]></category> <category><![CDATA[EN60601]]></category> <category><![CDATA[EN60601-1]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[Home Healthcare Environments]]></category> <category><![CDATA[Home Use]]></category> <category><![CDATA[Home Use Environment]]></category> <category><![CDATA[Home Use Med Dvcs]]></category> <category><![CDATA[MDD]]></category> <category><![CDATA[Medical]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Device Industry]]></category> <category><![CDATA[Medical Device Regulatory]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Risk Management]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=4123</guid> <description><![CDATA[On 2 Feb 2015 the previous site for the List of Harmonized Standards for the MDD and other Medical Device Directives (AIMDD & IVDD) moved to a new location. The old MDD Harmonized Standards Listing used to be located at]]></description> <content:encoded><![CDATA[<p><img decoding="async" class="wp-image-4832 size-thumbnail alignleft" src="http://www.eisnersafety.com/wp-content/uploads/2015/02/EU-FLags-in-front-of-EU-Parliment-2015-150x150.jpg" alt="" width="150" height="150" /><span style="font-family: arial, helvetica, sans-serif; font-size: small;">On 2 Feb 2015 the previous site for the List of Harmonized Standards for the MDD and other Medical Device Directives (AIMDD & IVDD) moved to a new location.</span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">The old MDD Harmonized Standards Listing used to be located at the website address of <strong style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://bit.ly/MDD_Harmonized_Stds_Listing" target="_blank" rel="noopener noreferrer">http://bit.ly/MDD_Harmonized_Stds_Listing</a></strong> but as of 2 Feb 2015 the site has been archived. The new site can be found by following the instructions on the archived site. First click on the link in the bright yellow band on the top of the old site titled “<strong style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://ec.europa.eu/growth/index_en.htm" target="_blank" rel="noopener noreferrer">Internal Market, Industry, Entrepreneurship and SMEs website</a></strong>“, then on the new page that opens click on the “<strong style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://ec.europa.eu/growth/single-market/index_en.htm" target="_blank" rel="noopener noreferrer">Single Market and Standards</a></strong>” link, then on the left hand bar select the link titled “<strong style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://ec.europa.eu/growth/single-market/european-standards/index_en.htm" target="_blank" rel="noopener noreferrer">European Standards</a></strong>“, then on the next web page select the link on the left hand bar titled “<strong style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm" target="_blank" rel="noopener noreferrer">Harmonised Standards</a></strong>“. Then search for the section titled “Healthcare engineering” and select the applicable medical device directive you are looking for:</span></p> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a title="Medical devices (MDD)" href="http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm" target="_blank" rel="noopener noreferrer">Medical devices (MDD)</a></strong></span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a title="Active implantable medical devices" href="http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices/index_en.htm" target="_blank" rel="noopener noreferrer">Active implantable medical devices (AIMDD)</a></strong></span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a title="In vitro diagnostic medical devices" href="http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices/index_en.htm" target="_blank" rel="noopener noreferrer">In vitro diagnostic medical devices (IVDD)</a></strong></span></li> </ul> <div><span style="font-family: arial, helvetica, sans-serif; font-size: small;">In addition to the Harmonized List of Standards updated web pages the <strong><a href="http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm" target="_blank" rel="noopener noreferrer">Medical Devices Home Page</a></strong> (The important links are mostly on the left hand side of the web page) on the Europa website has been updated recently too and there seems to be more info and it appears to be better organized. I haven’t had time to search thru all of the volumes of info in it. I think there are a few kinks on this new site as one page I clicked a link and the page would disappear after about 2 seconds on the page and another link I got an error message on the webpage it landed on. So, it is a much improved site but also expect some bugs hopefully only for a short while. Let Europa know about the issues at <strong><a href="mailto:%20grow-webmaster@ec.europa.eu">grow-webmaster@ec.europa.eu</a></strong> so they can get fixed.</span></div> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">If you need help with your EU CE for the Mark Medical Device Directive, the Active Implantable Medical Device Directive or the IVD Directive, email Leo Eisner directly at <strong><a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a></strong>, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>). </span></p> ]]></content:encoded> </item> <item> <title>NBRG Risk Mgmt Draft Consensus Paper on Interpretation & Application of Annexes Z in EN ISO 14971:2012</title> <link>https://eisnersafety.com/2014/07/02/nbrg-risk-mgmt-draft-consensus-paper-on-interpretation-application-of-annexes-z-in-en-iso-149712012/?utm_source=rss&utm_medium=rss&utm_campaign=nbrg-risk-mgmt-draft-consensus-paper-on-interpretation-application-of-annexes-z-in-en-iso-149712012</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Wed, 02 Jul 2014 08:13:46 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[Active Implantable Medical Devices Directive]]></category> <category><![CDATA[AIMDD]]></category> <category><![CDATA[EN ISO 14971]]></category> <category><![CDATA[EN ISO 14971:2012]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[ISO 14971]]></category> <category><![CDATA[ISO 14971:2007]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[IVD Directive]]></category> <category><![CDATA[IVDD]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[NBRG]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Notified Body Recommendation Group]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[TEAM-NB]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3979</guid> <description><![CDATA[Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available. Be forewarned that the document is not yet adopted by the NBRG, which can only be]]></description> <content:encoded><![CDATA[<p><span style="font-size: small;"><span style="font-family: arial, helvetica, sans-serif;"><br /> <a href="http://www.eisnersafety.com/wp-content/uploads/2014/07/shareasimageNBRG-RM-Consensus-Paper-Draft.jpg"><img loading="lazy" decoding="async" class="alignleft size-full wp-image-3981" style="margin-top: -2px; margin-bottom: -2px;" title="shareasimageNBRG RM Consensus Paper Draft" src="http://www.eisnersafety.com/wp-content/uploads/2014/07/shareasimageNBRG-RM-Consensus-Paper-Draft.jpg" alt="" width="155" height="218" /></a><span style="font-family: arial, helvetica, sans-serif;">Just released as of June 25, 2014 this <strong><a href="http://www.team-nb.org/documents/2014/NBRG_Final_WG%20RM%20Draft_Not_Yet_adopted_142506_2.pdf" target="_blank" rel="noopener noreferrer">NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012</a> </strong></span></span><span style="font-family: arial, helvetica, sans-serif;">is finally available. Be forewarned that the document<em style="font-family: arial, helvetica, sans-serif; font-size: small;"><strong> is not yet adopted by the NBRG</strong></em>, which can only be done at the next Meeting in October 2014. Hopefully it will be adopted at that meeting. I will check in with my NBRG Risk Management Working Group contacts to find out if they know more about that issue.<span id="more-3979"></span></span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">But let’s take this chance to review a little about the document and the history of the EN ISO 14971:2012 Annex Z’s. Future posts will get into more details. The following 3 paragraphs come straight from the introduction of the document as the Working Group summarizes the situation really well. I happen to know a couple of these working group members personally and I know they have a very good handle on the situation and they have provided some very good background. </span></p> <p style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; line-height: 18px;">In October 2010, the regular review of ISO 14971:2007 which is the basis of EN ISO 14971:2009 was closed by a broad majority of votes confirming the existing status and the wide-spread acceptance of this standard in the medical devices community, including competent authorities. In November 2010, the European Commission raised a formal objection against the use of several harmonized standards, including EN ISO 14971, followed by an in-depth assessment of the coverage of the Essential Requirements of the Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) by these standards.</span></p> <p style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small;">As a result of these objections, the Annexes Z to EN ISO 14971 were modified, resulting in EN ISO 14971:2012. This amendment of the EN ISO 14971 standard did not modify the normative parts of ISO 14971:20071. The Annexes Z describe the extent of presumption of conformity that can be based on application of the normative requirements of ISO 14971 alone. The “content deviations”, expressed in the revised Annexes Z, between ISO 14971:2007 and the Medical Device Directives have been commented by many experts in the field of risk management and resulted in diverging interpretations from different stakeholders (e.g. manufacturers, notified bodies, competent authorities).</span></p> <p style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small;">This document has been prepared as a Notified Body Consensus Paper by a working group headed by the NBRG Vice Chair, with representatives from several European Notified Bodies and industry associations COCIR, Eucomed, EDMA and ZVEI. The paper aims to provide a practical interpretation of these “content deviations” to the Medical Device Directives and give guidance as to how to implement the risk management requirements. The work consolidates prior publications of various sources and is intended to facilitate common understanding between industry and Notified Bodies.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):</span></p> <ul> <li><strong style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.EisnerSafety.com/mddi-article-collaboration-holds-the-key-to-clarity-on-en-iso-149712012/">MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”</a></strong></li> </ul> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a href="http://www.EisnerSafety.com/nbrg-consensus-document-on-en-iso-149712012-is-on-its-way-mdm-west-14-presentation/">NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation</a></strong></span><span style="font-size: 13px;"> </span></li> </ul> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a href="http://www.EisnerSafety.com/nbrg-call-for-industry-participation-survey-understanding-annex-z-en-iso-149712012/">NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012</a></strong></span></li> </ul> <div><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at <strong><a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a></strong>, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>).</span></div> ]]></content:encoded> </item> <item> <title>Eucomed Pleased with EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices</title> <link>https://eisnersafety.com/2014/06/18/eucomed-pleased-with-eu-commissions-conclusions-on-joint-plan-for-immediate-actions-for-medical-devices/?utm_source=rss&utm_medium=rss&utm_campaign=eucomed-pleased-with-eu-commissions-conclusions-on-joint-plan-for-immediate-actions-for-medical-devices</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Wed, 18 Jun 2014 21:11:38 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[EU Commission]]></category> <category><![CDATA[EU Council]]></category> <category><![CDATA[Eucomed]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Device Industry]]></category> <category><![CDATA[Medical Device Regulatory]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Proposed Medical Device Regulation]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3921</guid> <description><![CDATA[Eucomed Press Release Welcomes the EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices   This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions]]></description> <content:encoded><![CDATA[<h4><a href="http://www.eisnersafety.com/wp-content/uploads/2014/06/shareasimageeucomed.jpg"><img loading="lazy" decoding="async" class="alignleft size-full wp-image-3922" style="margin-top: -2px; margin-bottom: -2px;" title="Eucomed_Medical_Devices_As_We_Age" src="http://www.eisnersafety.com/wp-content/uploads/2014/06/shareasimageeucomed.jpg" alt="" width="228" height="161" /></a><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Eucomed Press Release Welcomes the EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices</span></h4> <p> </p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions for Medical Devices.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">On 18 June 2014 <strong><a href="http://www.eucomed.org/newsroom/129/187/Eucomed-welcomes-Commission-conclusions-on-Joint-Plan-for-Immediate-Actions-for-Medical-Devices?cntnt01template=detail-pr" target="_blank" rel="noopener noreferrer">Eucomed released a Press Release</a></strong> about a document the EU Commission released on 17 June 2014. <strong><a href="http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%2010343%202014%20INIT" target="_blank" rel="noopener noreferrer">The title of the document is “<span style="line-height: 18px;">COMMISSION STAFF WORKING DOCUMENT Implementation of the </span><span style="line-height: 18px;">Joint Plan for Immediate Actions under the existing Medical Devices </span></a></strong><span style="line-height: 18px;"><strong><a href="http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%2010343%202014%20INIT" target="_blank" rel="noopener noreferrer">legislation”</a></strong>. </span>Eucomed seems to be pleased with the EU Commission on the approach they are taking in this Joint Plan document. In the press release Eucomed says: </span><span style="font-family: arial, helvetica, sans-serif; font-size: small;">“The Commission’s assessment confirms that much needed improvements to Europe’s notified body system have been successfully implemented and are already yielding tangible results. The Commission also outlines a series of remaining gaps in the system that it believes can only be appropriately addressed in the new Regulation.”<span id="more-3921"></span></span> <span style="font-family: arial, helvetica, sans-serif; font-size: small;">The</span><span style="font-family: arial, helvetica, sans-serif; font-size: small;"> document comes from the Secretary-General of the European Commission and is addressed to the EU Council (<span style="line-height: 18px;">Mr Uwe CORSEPIUS, Secretary-General of the Council of the European </span><span style="line-height: 18px;">Union).</span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">The <strong><a href="http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%2010343%202014%20INIT" target="_blank" rel="noopener noreferrer">Commission Staff Working Document</a></strong> provides some backg</span><span style="font-family: arial, helvetica, sans-serif; font-size: small;">round about the history of why this occurred (the Joint Plan) and as Eucomed stated this document “outlines system improvements achieved thus far and highlights remaining gaps to be addressed in new Regulation”. The <strong><a href="http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%2010343%202014%20INIT" target="_blank" rel="noopener noreferrer">Commission Staff Working Document</a></strong> says: “<span style="line-height: 18px;">As an immediate response to the PIP” (Poly Implant Prothèse Company) “crisis” (fraudulently made breast implants)”, the Commission, in February 2012, took </span><span style="line-height: 18px;">the initiative of agreeing with the Member States a Joint Plan for Immediate Actions </span><span style="line-height: 18px;">aimed at tightening controls and at restoring patient confidence in the regulatory </span><span style="line-height: 18px;">system on the basis of existing legislation, pending the adoption by the co-legislator </span><span style="line-height: 18px;">of the new legislation and its subsequent entry into application. </span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><span style="line-height: 18px;">Two years after the launch of the Joint Plan, this Commission Staff Working </span><span style="line-height: 18px;">Document communicates the achievements of the plan. It also proposes some aspects </span><span style="line-height: 18px;">that should be continued and intensified.” </span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">The press release from Eucomed some very positive comments such as: “The conclusions outlined in the….document reflect the collective feedback from Eucomed member companies that Europe’s notified body system is now subject to tightened controls with tangible results such as unannounced audits of manufacturers and notified bodies.” :”Eucomed…welcomes the Commussion’s concrete progress…”</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">Serge Bernasconi, Eucomed CEO said “<em>The Action Plan very much reflects our recommendation to implement a ‘<strong><a href="http://medtechviews.eu/article/where-are-we-again-mdd-and-ivdd" target="_blank" rel="noopener noreferrer">reinforced control procedure</a></strong>’ rather than turning the system on its head with a complex, costly and overly bureaucratic measure like the ‘scrutiny procedure’ contained in the Commission’s initial proposal and the European Parliament’s first reading agreement.”</em></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><em></em>In conclusion of the press release Eucomned goes on to say: “Eucomed also welcomes the Commission’s clear delineation in the final pages of their report of the issues that are critical to a strengthened system and must be addressed in the new Regulation, including the obligations of notified bodies, clinical evaluation and vigilance. The European medical device industry also welcomes the Commission’s reference to registries and looks forward to further dialogue on the topic. …Mr Bernasconi said, ‘<em>…perhaps more importantly, in this document they have made clear where there is more work to be done. I am hopeful that the Commission’s emphasis on these points will serve as inspiration to the Council as it continues negotiations towards its position</em>.'”</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">Below is the conclusion section of the Commission’s Staff Working Document which is what Eucomed was praising in the conclusion of their press release.</span></p> <p style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">Substantial progress has until now been made in the implementation of the plan. In particular the following achievements can be noted:</span></p> <ul> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">Member States have re-assessed the qualifications of the notified bodies in <span style="line-height: 18px;">charge of assessing high-risk devices, thus the vast majority of notified bodies. </span><span style="line-height: 18px;">Member States have, in many cases, modified the scope of the activities of the </span><span style="line-height: 18px;">notified bodies;</span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">A majority of Member States have requested their notified bodies to carry out </span><span style="line-height: 18px;">unannounced audits and have asked notified bodies to ensure they are informed </span><span style="line-height: 18px;">about incident reports. Notified bodies have reported that they are in the </span><span style="line-height: 18px;">process of launching the unannounced audits; </span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">Joint audits of notified bodies by teams involving auditors from several </span><span style="line-height: 18px;">Member States and the Commission (FVO) have until May 2014 been carried </span><span style="line-height: 18px;">out in 22 out of 23 countries having notified bodies and is scheduled for the </span><span style="line-height: 18px;">remaining. The voluntary joint audits have been judged as very useful by all </span><span style="line-height: 18px;">parties involved; </span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">Two Commission measures, respectively to ensure a consistent application of </span><span style="line-height: 18px;">the criteria to be met for the designation of notified bodies and on the items to </span><span style="line-height: 18px;">be verified by the notified bodies during an audit were adopted in September </span><span style="line-height: 18px;">2013. The first of the two measures has made the joint audits mandatory for </span><span style="line-height: 18px;">new designations and re-designations of notified bodies. Five such audits have </span><span style="line-height: 18px;">been carried out until April 2014. About 20 mandatory joint audits are foreseen </span><span style="line-height: 18px;">for 2014; </span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">Most Member States have reported on their market surveillance activities. This </span><span style="line-height: 18px;">information is used as a base for assessing the need for further improvement; </span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">Monthly vigilance teleconferences with Member States, chaired by the </span><span style="line-height: 18px;">Commission services, have been launched and become regular. The </span><span style="line-height: 18px;">teleconferences have proved to be a very efficient means of ensuring/</span><span style="line-height: 18px;">improving coordination between Member States; </span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">The Commission Joint Research Centre (JRC) has started a metadata analysis </span><span style="line-height: 18px;">in the field of vigilance reporting and is conducting a screening of publicly </span><span style="line-height: 18px;">available sources with regard to the safety of medical devices relevant for the </span><span style="line-height: 18px;">European Market;</span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">A Commission Recommendation on the use of a specific system for </span><span style="line-height: 18px;">traceability of medical devices (UDI) was adopted in April 2013; </span></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; line-height: 18px; color: #008000;">Dialogues with Member States are on-going on product registers; </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><span style="line-height: 18px;">With regard to incident reporting from medical practitioners and patients, </span><span style="line-height: 18px;">Member States however prefer to develop systems at national level.</span></span></li> </ul> </ul> <p style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">The positive progress in the implementation of the plan has been discussed between Health Ministers in several EPSCO Councils.</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><br /> Many Member States and stakeholders have underlined the importance to continue and intensify the work on certain aspects of the Joint Plan. The focus should be on problematic issues identified during the implementation of this plan that are not yet resolved, such as:</span></p> <ul> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">Market surveillance</span></li> </ul> </ul> <p style="padding-left: 90px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">The information received under the Joint Plan and the national market surveillance programmes indicate great divergences between the Member States with regard to resources attributed and how market surveillance is carried out. Many Member States recognise that because of a shortage of resources, market surveillance is only reactive and that no proactive surveillance is carried out.<br /> </span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">These differences in approaches influence decisions on which products are concretely checked and on which aspects they are checked. Experience has shown that national competent authorities sometimes react in different ways to the same problems. A consequence is that whilst in some Member States the placing on the market or putting into service of a given device is banned or restricted, it may freely circulate in other Member States.<br /> </span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">Some of the 20 actions for safer and compliant products for Europe outlined in a Commission communication of last year can be a source of inspiration for the concrete actions to be undertaken, in order to address those issues and to develop best practices (for example, a best practice would be to develop a common understanding of market surveillance and better co-ordination and communication on surveillance data, as set out in paragraph 3 of that Communication). </span></p> <p style="padding-left: 90px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">On the international level, the activities carried out within IMDRF could contribute to an increased coordination.</span></p> <ul style="font-size: 1.17em;"> <ul> <li><span style="font-size: small; font-weight: normal; font-family: arial, helvetica, sans-serif; color: #008000;">Functioning of notified bodies</span></li> </ul> </ul> <div style="padding-left: 90px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">The Joint Plan has led to the establishment of a new structure for the designation and supervision by Member States of notified bodies. Also guidance to notified bodies in their performance of audits and assessments has been given through a Recommendation. Assessment standards should also be improved through the own measures taken by many of the notified bodies in the Team NB framework.</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><br /> There are clear signs of the positive effect of these measures, justifying the continuation of these efforts.</span></div> <ul> <ul> <li> <h3><span style="font-size: small; font-weight: normal; font-family: arial, helvetica, sans-serif; color: #008000;"> Communication and transparency</span></h3> </li> </ul> </ul> <p style="padding-left: 90px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">The next steps on UDI and reporting of incidents from healthcare professionals are foreseen to be taken following the adaption of the new legislation.</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><br /> The work on making best use of registers for providing data and identifying problems with devices that has been launched under the Joint Plan should be pursued under the current PARENT Joint Action and in follow up actions envisaged.</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><br /> The proposals of the JRC project on identifying and developing recommendations for mechanisms to detect signals, trends and increased incident frequency more effectively should allow reducing the number of problems at the source and thus more effectively allocate the scarce resources attributed to market surveillance and vigilance. The results, that should become available mid-2014, should allow for discussions with Member States and stakeholders on the improvements in this respect.</span></p> <ul> <ul> <li><span style="font-size: small; font-weight: normal; font-family: arial, helvetica, sans-serif; color: #008000;"> Sharing of knowledge and good practices</span></li> </ul> </ul> <div style="padding-left: 90px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">The actions undertaken under the Joint Plan have demonstrated the value of sharing knowledge and best practices between Member States. The experiences of the joint assessments of notified bodies have been very positive in this respect. In this context a joint training has been undertaken and more are foreseen. It could be beneficial to make use of this practice of joint training in other fields of activity.</span></div> <div style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><br /> The measures described above can all be undertaken under the framework of the Joint Plan and within the existing legislation. For other important aspects, it is not possible under the current legal provisions to reach the desired objectives.</span><br /> <span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;"><br /> Therefore the proposed new Regulations contain provisions which aim to solve in particular the problems relating to:</span></div> <div> <ul> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">the scope of the legislation,</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">the governance of the system and its transparency,</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">certain obligations of notified bodies, in particular in relation to mandatory unannounced audits,</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">clinical evaluation,</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">the risk classification of devices and the safety and performance requirements,</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">obligations of economic operators,</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">reporting of incidents by users and patients to the Competent Authorities,</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">certain aspects relating to vigilance system and market surveillance,</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">the role and the functioning of the database Eudamed and the access of notified bodies to Eudamed, and</span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif; color: #008000;">the traceability of devices.</span></li> </ul> </ul> <div style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif; font-size: small; color: #008000;">Each of these points is pivotal towards ensuring patient and consumer safety and restoring confidence in the regulatory framework. </span></div> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at <strong><a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a></strong>, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>).</span></p> </div> ]]></content:encoded> </item> <item> <title>EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD</title> <link>https://eisnersafety.com/2014/05/23/en60601-12006-a12013-has-been-harmonized-under-the-mdd/?utm_source=rss&utm_medium=rss&utm_campaign=en60601-12006-a12013-has-been-harmonized-under-the-mdd</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Fri, 23 May 2014 06:21:33 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[60601 series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1 3rd ed.]]></category> <category><![CDATA[A1]]></category> <category><![CDATA[Amendment 1]]></category> <category><![CDATA[Annex ZA]]></category> <category><![CDATA[Annex ZA & ZZ]]></category> <category><![CDATA[Annex ZZ]]></category> <category><![CDATA[CENELEC]]></category> <category><![CDATA[EFTA]]></category> <category><![CDATA[EN 60601-1:06 + A1:13]]></category> <category><![CDATA[EN 60601-1:06 + Amendment 1:13]]></category> <category><![CDATA[EN60601]]></category> <category><![CDATA[EN60601-1]]></category> <category><![CDATA[EN60601-1:06 + A1:13]]></category> <category><![CDATA[EN60601-1:06 + Amendment 1:13]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[EU Harmonized Standards]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[IEC60601-1]]></category> <category><![CDATA[IEC60601-1 3rd ed.]]></category> <category><![CDATA[List of Harmonized Standards]]></category> <category><![CDATA[MDD]]></category> <category><![CDATA[MDD Amendment]]></category> <category><![CDATA[MDD Harmonized Standards]]></category> <category><![CDATA[MDD Harmonized Standards List]]></category> <category><![CDATA[Medical]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Device Industry]]></category> <category><![CDATA[Medical Device Regulatory]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[OJ]]></category> <category><![CDATA[OJEU]]></category> <category><![CDATA[Risk Management]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3843</guid> <description><![CDATA[This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News]]></description> <content:encoded><![CDATA[<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><a href="http://www.eisnersafety.com/wp-content/uploads/2014/05/shareasimageEN60601-1+A1_2013CoverPgShareAsImage1.png"><img loading="lazy" decoding="async" class="alignleft size-medium wp-image-3867" style="margin-top: -2px; margin-bottom: -2px;" title="EN60601-1+A1_2013CoverPg" src="http://www.eisnersafety.com/wp-content/uploads/2014/05/shareasimageEN60601-1+A1_2013CoverPgShareAsImage1-212x300.png" alt="" width="212" height="300" /></a>This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD.</span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile.</span></p> <h2><span style="font-size: small; font-family: arial, helvetica, sans-serif;">What’s The Big News About?<br /> </span></h2> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">On 16 May 2014 the Official Journal of the European Union (OJEU) published an <strong><a href="http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014XC0516(04)&from=EN" target="_blank" rel="noopener noreferrer">updated Harmonized Standards List for the MDD 93/42/EEC (2014/C 149/02)</a></strong>, therefore making it a Harmonized Standard under the MDD. Of the five changes to the list for “first publication” documents the one of concern for this post is EN 60601-1:2006 + A1:2013 (it is also known as Edition 3.1 which means 3rd edition of EN 60601-1 [published 2006] + Amendment 1 (or A1) [published 2013]). The cessation of presumption of conformity for the EN 60601-1:2006 (3rd edition without A1) has been set to be 31 December 2017 ( a 3 year transition period) but there is more to the picture so please read on otherwise you will run into a problem before that date.<span id="more-3843"></span></span></p> <h2><span style="font-family: arial, helvetica, sans-serif; font-size: small;">Remember That Harmonized Standards Are Voluntary:</span></h2> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">NOTE: A reminder that EU Harmonized Standards are not mandatory to meet the Essential Requirements of the MDD but do help make it easier to meet the Directive than going it without the use of Harmonized Standards typically but it is your choice how to approach this issue. I do recommend, to my clients, that they use Harmonized Standards, when they can, since they are common standards that Notified Bodies and Test Houses understand and are familiar with. So, it is easier to use a Harmonized Standard like EN 60601-1 than to prove, with a higher burden of proof, using a different standard(s) or internal specification(s), etc. that the Notified Bodies may not be as familiar with and then the manufacturer has a higher bar to prove to the Notified Body to prove they meet the Essential Requirements of the MDD.</span></p> <h2><span style="font-family: arial, helvetica, sans-serif; font-size: small;">What’s That Note All About?</span></h2> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">In the recently released OJEU Harmonized Standards Listing for EN60601-1:2006+A1:2013 there is an extensive note that discusses the dates of cessation which reads verbatim: </span></p> <p style="padding-left: 30px;"><span style="font-size: small; font-family: arial, helvetica, sans-serif;">“<span style="line-height: 18px;">Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The </span><span style="line-height: 18px;">date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-</span><span style="line-height: 18px;">1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As </span><span style="line-height: 18px;">from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in </span><span style="line-height: 18px;">Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, </span><span style="line-height: 18px;">to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.”</span></span></p> <h2><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><span style="line-height: 18px;">What’s The Bottom Line?</span></span></h2> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><span style="line-height: 18px;">So, what does the above text really mean? You will need to consider the A1 Annex ZZ before the end of the transition period for the standard EN60601-1:2006 (3rd edition). The EN60601-1:2006 transition period ends on 31 December 2017 but on 1 January 2016 you will need to comply, if using this voluntary standard, with the clauses of Annex ZZ of EN60601-1:2006+A1:2013 to be provided with the presumption of conformity that is needed to help meet the essential requirements of the EU Directive in relation to the EN60601-1 standard. </span></span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><span style="line-height: 18px;">To learn more about the Annex ZZ refer to the 2nd post in the below listing of past posts on the 60601-1 standard.</span></span></p> <h2><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><span style="line-height: 18px;">How Many Changes Are There in A1:2013 of EN 60601-1:2006 + A1:2013?</span></span></h2> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><span style="line-height: 18px;">There are quite a few changes in A1 as there are 496 changes that were brought into the standard. Why so many changes? The original 3rd edition of the standard was released before it may have been totally ready but after about 10 years of development the standard committee decided they needed to get something out before the project would have been sent back to the drawing board (meaning it could have taken another couple years to release it) by IEC rules and also because at that point there was so much anticipation of the release by industry and the Test Houses the standard committee decided it was mature enough to get it out the door. Of the 496 changes only about 70 of the changes are moderate to significant impact and the rest are editorial and minor corrections including typo corrections too.</span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><span style="line-height: 18px;">For easy reference we have listed below some of our past posts on 60601-1 and 3rd edition + A1 which may be of interest to you.</span></span></p> <ol> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.eisnersafety.com/qa-on-osha-nrtl-for-aami-es-60601-1-3rd-ed-a1/"><strong>Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1</strong></a></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><strong><a href="http://www.EisnerSafety.com/status-update-on-en-60601-106-a113-for-eu-mdd-annexes-za-zz/">Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ</a></strong></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.eisnersafety.com/fda-extends-aami-es-60601-1-transition-date-to-31-dec-13-other-important-changes-recognition-lists-031032"><strong>FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032</strong></a></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><strong><a href="http://www.EisnerSafety.com/iec-tr-62348-2012-added-in-assessment-of-impact-of-most-significant-changes-of-iec-60601-1-2005-amendment-1/">IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1</a> </strong>(This Technical Report talks about the significant and moderate changes to the standard of the 496 changes that were made to the standard.) </span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.EisnerSafety.com/when-will-iec-60601-105a112-turn-into-en-standard/"><strong>When will IEC 60601-1:05+A1:12 turn into EN Standard?</strong></a></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.EisnerSafety.com/iec-60601-12012-consolidated-3-1-edition-just-published/"><strong>IEC 60601-1:2012 Consolidated 3.1 Edition Just Published</strong></a></span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><strong><a href="http://www.EisnerSafety.com/amendment-1-of-iec-60601-105-3rd-edition-has-been-published-by-iec/">Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC</a></strong></span></li> </ol> <div><span style="font-family: arial, helvetica, sans-serif; font-size: x-small;"><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If you need additional support for IEC or EN 60601-1, 3rd edition + A1 email Leo Eisner at <strong><a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a></strong>, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>).</span></span></div> ]]></content:encoded> </item> <item> <title>Status Update on NBRG Risk Management Consensus Document</title> <link>https://eisnersafety.com/2014/04/30/status-update-on-nbrg-risk-management-consensus-document-status/?utm_source=rss&utm_medium=rss&utm_campaign=status-update-on-nbrg-risk-management-consensus-document-status</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Wed, 30 Apr 2014 19:08:52 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[Active Implantable Medical Devices Directive]]></category> <category><![CDATA[AIMDD]]></category> <category><![CDATA[EN ISO 14971]]></category> <category><![CDATA[EN ISO 14971:2012]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[ISO 14971]]></category> <category><![CDATA[ISO 14971:2007]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[IVD Directive]]></category> <category><![CDATA[IVDD]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[NBRG]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Notified Body Recommendation Group]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[TEAM-NB]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3814</guid> <description><![CDATA[This post is a status update on the NBRG RMWG Risk Management Consensus Document 30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to]]></description> <content:encoded><![CDATA[<p><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><a href="http://www.eisnersafety.com/wp-content/uploads/2014/04/shareasimageENISO14971_2012.png"><img loading="lazy" decoding="async" class="alignleft size-medium wp-image-3822" style="margin-top: -2px; margin-bottom: -2px;" title="shareasimageENISO14971_2012" src="http://www.eisnersafety.com/wp-content/uploads/2014/04/shareasimageENISO14971_2012-211x300.png" alt="" width="211" height="300" /></a>This post is a status update on the NBRG RMWG Risk Management Consensus Document</span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012. This meeting has come about because the NBRG RMWG received some feedback recently from the EU Commission and they will consider it and roll it into this document. </span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><span id="more-3814"></span>The consensus document’s purpose is to reduce the confusion around the EU Harmonized Standard <strong><a href="http://webshop.ds.dk/catalog/documents/M265310_attachPV.pdf" target="_blank" rel="noopener noreferrer">EN ISO 14971:2012 Annexes ZA, ZB, & ZC</a></strong> that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives). The previous plan was to have this Consensus document completed and released by Mid to Late April ’14 but at this point it is hoped the NBRG RMWG will have a final released document by the end of June 2014. We look forward to sending good news about the progress of this document over the next month or so.</span></p> <p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):</span></p> <ul> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a href="http://www.EisnerSafety.com/mddi-article-collaboration-holds-the-key-to-clarity-on-en-iso-149712012/">MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”</a></strong></span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a href="http://www.EisnerSafety.com/nbrg-consensus-document-on-en-iso-149712012-is-on-its-way-mdm-west-14-presentation/">NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation</a></strong></span></li> <li><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><strong><a href="http://www.EisnerSafety.com/nbrg-call-for-industry-participation-survey-understanding-annex-z-en-iso-149712012/">NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012</a></strong></span></li> </ul> <div><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at <strong><a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a></strong>, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>).</span></div> ]]></content:encoded> </item> <item> <title>MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”</title> <link>https://eisnersafety.com/2014/03/08/mddi-article-collaboration-holds-the-key-to-clarity-on-en-iso-149712012/?utm_source=rss&utm_medium=rss&utm_campaign=mddi-article-collaboration-holds-the-key-to-clarity-on-en-iso-149712012</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Sat, 08 Mar 2014 00:11:18 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[Active Implantable Medical Devices Directive]]></category> <category><![CDATA[AIMDD]]></category> <category><![CDATA[EN ISO 14971]]></category> <category><![CDATA[EN ISO 14971:2012]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[ISO 14971]]></category> <category><![CDATA[ISO 14971:2007]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[IVD Directive]]></category> <category><![CDATA[IVDD]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[NBRG]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Notified Body Recommendation Group]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[TEAM-NB]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3678</guid> <description><![CDATA[7 March 2014 – MD&DI article written by Leo Eisner of Eisner Safety Consultants about the confusion of the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard]]></description> <content:encoded><![CDATA[<p>7 March 2014 – <strong><a href="http://www.mddionline.com/" target="_blank" rel="noopener noreferrer">MD&DI</a> <a href="http://bit.ly/EN_ISO14971-2012_Consensus_Doc_in_process_with_NBRG" target="_blank" rel="noopener noreferrer">article written by Leo Eisner</a></strong> of Eisner Safety Consultants about the confusion of the EU Harmonized Standard <strong><a href="http://webshop.ds.dk/catalog/documents/M265310_attachPV.pdf" target="_blank" rel="noopener noreferrer">EN ISO 14971:2012 Annexes ZA, ZB, & ZC</a></strong> that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives) and what is being done to reduce the confusion.</p> <p><span id="more-3678"></span>The NBRG (Notified Body Recommendation Group) Risk Management Working Group is working to put together a consensus document. A call to industry has been sent out to ask for participation in a survey on how your risk management system aligns with EN ISO 14971:2012 that will help in the direction of this consensus document so please take part in it. <strong><a href="http://bit.ly/EN_ISO14971-2012_Consensus_Doc_in_process_with_NBRG" target="_blank" rel="noopener noreferrer">Read the article for more details</a></strong> and a post that <strong><a href="http://bit.ly/NBRGSurveyOnAnnexZ_EN_ISO14971_2012" target="_blank" rel="noopener noreferrer">links to the survey</a></strong>.</p> <p>Past posts on this subject include:</p> <ul> <li><strong><a href="http://bit.ly/NBRGConsensusDocENISO14971-12Slides" target="_blank" rel="noopener noreferrer">NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation</a></strong></li> <li><strong><a href="http://bit.ly/NBRGSurveyOnAnnexZ_EN_ISO14971_2012" target="_blank" rel="noopener noreferrer">NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012</a></strong></li> </ul> <p>If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at <strong><a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a></strong>, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>).</p> ]]></content:encoded> </item> <item> <title>NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation</title> <link>https://eisnersafety.com/2014/03/07/nbrg-consensus-document-on-en-iso-149712012-is-on-its-way-mdm-west-14-presentation/?utm_source=rss&utm_medium=rss&utm_campaign=nbrg-consensus-document-on-en-iso-149712012-is-on-its-way-mdm-west-14-presentation</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Fri, 07 Mar 2014 06:51:26 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[Active Implantable Medical Devices Directive]]></category> <category><![CDATA[AIMDD]]></category> <category><![CDATA[EN ISO 14971]]></category> <category><![CDATA[EN ISO 14971:2012]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[ISO 14971]]></category> <category><![CDATA[ISO 14971:2007]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[IVD Directive]]></category> <category><![CDATA[IVDD]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[NBRG]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Notified Body Recommendation Group]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[TEAM-NB]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3663</guid> <description><![CDATA[On Tuesday Feb 11, 2014 at the UBM Canon Communications MD&M West Conference Leo Eisner of Eisner Safety Consultants presented this material as the Track Chair for “Improving Risk Management Strategies And Procedures”. He spoke on the proposed Consensus Guidance]]></description> <content:encoded><![CDATA[<p><span style="font-family: arial, helvetica, sans-serif; font-size: small; line-height: 19px;">On Tuesday Feb 11, 2014 at the UBM Canon Communications MD&M West Conference Leo Eisner of Eisner Safety Consultants presented this material as the Track Chair for “Improving Risk Management Strategies And Procedures”. He spoke on the proposed Consensus Guidance Document on EN ISO 14971:2012 that is currently being drafted by NBRG (the Notified Body Recommendation Group). EN ISO 14971:2012 was harmonized under the 3 Medical Devices Directives (Medical Device, In Vitro Diagnostic, and Active Implantable Medical Devices Directives) on 30 Aug 2013 and was released with no transition period so there no warning publicly. So, this has caused a lot of confusion and the confusion still reigns among manufacturers, notified bodies, and others. Read thru the slide deck to get an idea of the process for this consensus document that will hopefully help all sides in understanding the requirements and being able to come to a reasonable solution for this very confusing matter to many stakeholders. To help in this process it is highly recommended that you, as a medical device manufacturer, get involved by providing some feedback via an anonymous survey on how your risk management process works and if you follow parts of the EN ISO 14971:2012 process or just the ISO 14971:2007 (or EN ISO 14971:2009 which is equivalent to the ISO 14971:2007 document). </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small; line-height: 19px;"><span id="more-3663"></span>The live link to the survey is on the fourth set of pages on slide deck and is slide 8 of the presentation. The more participants in the survey the more likely your voices will be heard and we hope this will improve the potential outcome of the process.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: small; line-height: 19px;">On 8 February we <strong><a href="http://www.EisnerSafety.com/nbrg-call-for-industry-participation-survey-understanding-annex-z-en-iso-149712012">posted the NBRG letter</a></strong> which was a Call for Industry Participation in the Survey on Understanding Annex Z of EN ISO 14971:2012. </span></p> <pre><span style="font-family: arial, helvetica, sans-serif; font-size: small; line-height: 19px;">[slideshare id=32021997&doc=mdmwestpresentationonnbrgconsensusdocumentoneniso14971201211feb2014-140306235842-phpapp01&type=d]</span></pre> ]]></content:encoded> </item> <item> <title>NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012</title> <link>https://eisnersafety.com/2014/02/08/nbrg-call-for-industry-participation-survey-understanding-annex-z-en-iso-149712012/?utm_source=rss&utm_medium=rss&utm_campaign=nbrg-call-for-industry-participation-survey-understanding-annex-z-en-iso-149712012</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Sat, 08 Feb 2014 21:41:41 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[Active Implantable Medical Devices Directive]]></category> <category><![CDATA[AIMDD]]></category> <category><![CDATA[EN ISO 14971]]></category> <category><![CDATA[EN ISO 14971:2012]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[European Commission]]></category> <category><![CDATA[ISO 14971]]></category> <category><![CDATA[ISO 14971:2007]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[IVD Directive]]></category> <category><![CDATA[IVDD]]></category> <category><![CDATA[Medical Device Directive]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[NBRG]]></category> <category><![CDATA[Notified Body]]></category> <category><![CDATA[Notified Body Recommendation Group]]></category> <category><![CDATA[Risk Management]]></category> <guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=3628</guid> <description><![CDATA[This post discusses NBRG’s call to participate in an Industry Survey on Industry’s Practice of Risk Management Process per EN ISO 14971:2012. On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter]]></description> <content:encoded><![CDATA[<p>This post discusses NBRG’s call to participate in an Industry Survey on Industry’s Practice of Risk Management Process per EN ISO 14971:2012.</p> <p>On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a <a href="http://www.eisnersafety.com/wp-content/uploads/2014/02/NBRG_risk_management_survey_questions_140702_final.docx" target="_blank" rel="noopener noreferrer">letter</a> to industry to ask for their participation in a short survey (about 10 minutes long) to help the Notified Bodies understand what are industry’s current practices when it comes to conducting Risk Management Process on their medical devices and IVD’s and how it relates to EN ISO 14971:2012. As the letter says it is to “attempt to develop a practical interpretation on how to use and implement Risk Management in the context of the European Medical Devices Directives, more specifically the European version of ISO 14971:2007, as published in EN ISO 14971:2012.”</p> <p><span id="more-3628"></span></p> <p>Please join in on this <strong><a href="https://www.surveymonkey.com/s/Y3CYPNP" target="_blank" rel="noopener noreferrer">survey</a></strong>, as the more participation the more representative the data will be to the Notified Bodies and hopefully this will make for a better Consensus Document on EN ISO 14971:2012 Risk Management Process. Please complete your survey responses by 21 March 2014.</p> <p>To find out more about what is going on with this proposed Consensus Document please join me, Leo Eisner as <a href="http://www.eisnersafety.com/leo-eisner-track-chair-at-mdm-west-conf-11-feb-discuss-en-iso-149712012/">the track chair for Improving Risk Management Strategies and Procedures, at the MD&M West conference on Tuesday 11 February 2014</a>, as I discuss how we got to this point and what is hopefully going to culminate in a Consensus Document on Risk Management with regard to EN ISO 14971:2012.</p> <p>If you have questions about this topic or need help with compliance with your Medical products you can e-mail Leo Eisner at <a href="mailto:Leo@EisnerSafety.com">Leo@EisnerSafety.com</a> directly or call Leo at 503-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.</p> ]]></content:encoded> </item> </channel> </rss>