Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016.  I was out of work for about a month and so I got a close birds eye view of why the medical device and wellness device markets are exploding.  This explosion of interest comes from several factors including the “Super aging” of societies around the globe, Internet of Things (IoT), the portability of devices, the growth of wearable technologies and other factors discussed in the article.

There is a huge need to support those at home that are sick, injured, has an acute issue or chronic illness that want a comfortable life and would rather stay at home then be in a sterile hospital or other clinical setting any longer than they have too.  I know I was ready to get home after 2 days in the hospital, even though I had to rest at home, I was much more comfortable at home than in the hospital setting.  So, now I can appreciate how important it is to have these medical and wellness devices evaluated for the proper environment and proper standard(s) and to meet national regulations.   One of the issues that is important to this conversation is the blurry line between home use medical devices and wellness devices.  FDA has written guidances for both Home Use Medical Devices and Wellness Devices to clarify from their perspective.  There, also is a newer IEC System Committee called Active Assistive Living (SyC AAL) that is looking at the gaps in standards and other IEC technical documents for home use medical devices and non-medical devices (Some being wellness devices).  The article goes into detail on this SyC AAL and also looks at the medical electrical device standards focused around Home Use Medical Electrical Devices.

Enjoy the article and if you have interest in or need help with the IEC 60601-1 series, home use medical electrical devices or the SyC AAL please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.

Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.)

Our new service helps you identify the required standards and editions for your intended markets.                                                                   

Our service helps medical electrical device manufacturers (our specific focus of our database) keep up to date on new standards, updates to existing standards, and draft standards under development. This assures you can plan ahead of any major changes.

We reduce your burden on this time consuming task, so you can focus on what you are good at – developing products.

We do this at very reasonable rates.  We are offering to early adopters an extra discount on the price and extra time (3 months) will be added to the first year subscription. 

See our demo page for the types of reports we generate for the service. Find out more about the service.

We decided to take a little extra time to capture the large amount of information involved.. We will be Live by Mid Oct 2015.

Sign-up now for a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here. Also, early adopters get an extra discount on the price and will get an additional 3 months added to their first year subscription if you sign-up in time.

What does the Service Provide:

The service includes several databases:

1. The Standards database is the primary focus. It includes standards, technical reports, technical specifications and guides. It includes new documents, updates to existing documents, as well as drafts under development (e.g. New Work Proposals, Committee Drafts, etc.)
2. List of standards publishers and the associated country.
3. List of Medical Device Regulators and their websites (if available).
4. Guidance Documents related to the standards for key markets. [Coming Soon]

A periodic report** is provided as part of the service.

All paid subscribers will have the ability to:

• Run searches of subscribed databases
• Print out search results from displayed data
• Print out tables of results in tabular format
• Export data for generation of your own reports (based on terms of service)
• Multiple user log-in for your company (limited to 5 unique user log-ins)

Discount for Initial release: We are releasing the database in stages, the early adopters (Current stage – stage 1) will get a discount (20%) for the first annual subscription cycle and an additional 3 months added to their subscription if you sign-up in time.

Sign-up now to receive a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here.

Stage 2 will add Guidance Documents for the US, Canada, and EU. Also, list of standards publishers and the associated country will be expanded to cover 50+ countries. Stage 2 will be released by early 2016.

Stage 3 will expand the standards database to include US, EU, and Canadian versions of the IEC standards & IEC/ISO joint documents. It will also expand the regulators information and their websites beyond the key markets. Stage 3 will be released early Spring 2016.

Stage 4 will expand the standards database to include the supporting (non-electrical) medical standards used for your regulatory submissions e.g. ISO 10993 series, ISO 15223-1, etc. Stage 4 will be released early Fall 2016.

View details on the Subscription Levels

Please feel free to contact me with any questions you may have. I can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

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 medical electrical equipment & systems (MEE&S = IEC TC 62, SC 62A – 62D) and home use medical electrical equipment & systems (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).

We plan to go live with the db by the end of Sept 2015.

Please reserve your spot by September 28, 2015 for this db subscription service.

Some of the features will include [For Paid Subscribers unless noted otherwise]:

• 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.
• Receive either 2 or 4 reports per year (depending on Subscription level) summarizing:
  • key issues of that report cycle for MEE&S or home Use MEE&S,
  • estimated timeline for the publication of draft standards & other relevant documents of significance, and
  • full listing of all the documents in your part of the db with status information.
• 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)]
• Print out db search results the way you want them
• Export db search results for your use (limited by the terms & conditions of the db)

There are several parts of this db [For Paid Subscribers unless noted otherwise]:

• 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).
• List of standards publishers & associated country (this will cover 50+ countries) [includes free service level],
• 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),
• 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).

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.

Pricing starts at only:

• $4,500/year for Base Entry Subscription (2 reports per year and select either MEE&S or Home Use MEE&S part of db),
• $6,500/year for Mid-Level Subscription (4 reports per year and full access to db), or
• $9,000/year & up for Premium Subscription (2 personalized reports for your company’s needs based on conversations with Leo Eisner, 2 reports per year from the Premium Subscription level, and full access to db)
  All payments to be paid in US$ only.

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.

Please reserve your spot by September 28, 2015 for this db subscription service and to guarantee a discounted first year price and to obtain extra months added for free. 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.

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.

Please contact Leo Eisner to find out more details about this db. He can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing 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 “Internal Market, Industry, Entrepreneurship and SMEs website“, then on the new page that opens click on the “Single Market and Standards” link, then on the left hand bar select the link titled “European Standards“, then on the next web page select the link on the left hand bar titled “Harmonised Standards“. Then search for the section titled “Healthcare engineering” and select the applicable medical device directive you are looking for:

• Medical devices (MDD)
• Active implantable medical devices (AIMDD)
• In vitro diagnostic medical devices (IVDD)

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 Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants). 

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 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.

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.  

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.

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).

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.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation 

• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

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 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.

The consensus document’s purpose is to reduce the confusion around the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC 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.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”
• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

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.  Read the article for more details and a post that links to the survey.

Past posts on this subject include:

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

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.

On 8 February we posted the NBRG letter which was a Call for Industry Participation in the Survey on Understanding Annex Z of EN ISO 14971:2012. 

[slideshare id=32021997&doc=mdmwestpresentationonnbrgconsensusdocumentoneniso14971201211feb2014-140306235842-phpapp01&type=d]

On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter 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.”

Please join in on this survey, 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.

To find out more about what is going on with this proposed Consensus Document please join me, Leo Eisner as the track chair for Improving Risk Management Strategies and Procedures, at the MD&M West conference on Tuesday 11 February 2014, 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.

If you have questions about this topic or need help with compliance with your Medical products you can e-mail Leo Eisner at Leo@EisnerSafety.com directly or call Leo at 503-244-6151.  Leo is the Principal Consultant of Eisner Safety Consultants.

This could have a huge impact on the EU market place including the patients, medical device manufacturers (especially the smaller medical device companies), and put jobs at risk, as well.  See the article from Eucamed on a survey they did of medical device companies in Europe to get an idea of the costs involved with these proposed changes.  On 25 Sept 2013 Eucamed said they expressed “…disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI)….” in their Article titled Rushed deal leaves patient and jobs in second place.

There are several sources I rely on a regular basis to keep up to date on this changing landscape and the next two websites are some of my favorite blogs as they have very reliable information that is on point, sometimes they will even make a predication here or there (with decent odds of being right, but not always) and always helpful for the medical device manufacturer.

The first of the 2 websites I read regularly is Medical Device Academy.  The article provides analysis and interpretation of how the EU took the next step in approving the proposed medical device regulations. This article covers a lot of ground including the EU Commission Press Release about two new documents in relation to Notified Bodies, Eucamed’s Political Positioning, Next Steps in the Proposed Medical Device Regulations Approval Process (important to read), and lastly Why is there a Rush?

The second website I am always checking up on is MedicalDeviceslegal written by a lawyer that works at a boutique life sciences law firm Axon Lawyers located in the Netherlands who is able to keep a really good pulse of the industry and the development of these types of regulations, laws, directives, and such.  He has written many articles on this specific subject and has been following the process closely.  His latest article indicates that the “ENVI vote result worst of all worlds”.   He gives you the bad news straight up.

Other resources I rely on a pretty regular basis that also have articles on this subject are: 

• RAPS Regulatory Focus which has 2 articles for today 26 Sept 2013 on the subject:
• European Parliament Passes Landmark Medical Device, IVD Reform Proposals
• European Commission Strengthens Oversight of CE-Marking Process
• MASS DEVICE article I saw today on the topic but with other related articles from other days:
• EU panel approves FDA-like requirements for medical devices
• Fierce Medical Devices one article I saw today but with other related articles from other times:
• EU committee backs tougher, U.S.-style device approval system