<?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>IVD – Eisner Safety Consultants</title> <atom:link href="https://eisnersafety.com/category/ivd/feed/" rel="self" type="application/rss+xml" /> <link>https://eisnersafety.com</link> <description>Just another WordPress site</description> <lastBuildDate>Wed, 07 Aug 2024 21:08:25 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.7.2</generator> <item> <title>How to ID Applicable Standards – Combinate Podcast</title> <link>https://eisnersafety.com/2024/08/07/how-to-id-applicable-standards-combinate-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=how-to-id-applicable-standards-combinate-podcast</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Wed, 07 Aug 2024 21:08:23 +0000</pubDate> <category><![CDATA[10993]]></category> <category><![CDATA[13485]]></category> <category><![CDATA[14708]]></category> <category><![CDATA[14971]]></category> <category><![CDATA[15223-1]]></category> <category><![CDATA[20417]]></category> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1, 4th edition]]></category> <category><![CDATA[61010]]></category> <category><![CDATA[62304]]></category> <category><![CDATA[62366]]></category> <category><![CDATA[62366-1]]></category> <category><![CDATA[Active Implants]]></category> <category><![CDATA[Architecture Specification]]></category> <category><![CDATA[Aug 2024]]></category> <category><![CDATA[Combination Device]]></category> <category><![CDATA[Combination Product]]></category> <category><![CDATA[Design Specification]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[Draft Guidance]]></category> <category><![CDATA[EMC]]></category> <category><![CDATA[Essential Performance]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[EU Commission]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Final Guidance]]></category> <category><![CDATA[Guidance]]></category> <category><![CDATA[Guidance Documents]]></category> <category><![CDATA[Hamonised Standards]]></category> <category><![CDATA[Harmonized Standards]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[IEC 61010]]></category> <category><![CDATA[IMDRF]]></category> <category><![CDATA[Information provided by the manufacturer]]></category> <category><![CDATA[Interpretation Sheet 1]]></category> <category><![CDATA[ISH1]]></category> <category><![CDATA[ISO 10993]]></category> <category><![CDATA[ISO 13485]]></category> <category><![CDATA[ISO 14708]]></category> <category><![CDATA[ISO 15223-1]]></category> <category><![CDATA[ISO 20417]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[Labeling]]></category> <category><![CDATA[Law]]></category> <category><![CDATA[Marking]]></category> <category><![CDATA[MDD]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[MHRA]]></category> <category><![CDATA[Notified Bodies]]></category> <category><![CDATA[PEMS]]></category> <category><![CDATA[Podcast]]></category> <category><![CDATA[Quality Assurance]]></category> <category><![CDATA[Recognized Consensus Standards]]></category> <category><![CDATA[Regulation]]></category> <category><![CDATA[Regulatory Affairs]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[SaMD]]></category> <category><![CDATA[Software]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards Development]]></category> <category><![CDATA[State of the Art]]></category> <category><![CDATA[US]]></category> <category><![CDATA[Usability]]></category> <category><![CDATA[Usability Engineering Process]]></category> <category><![CDATA[User Interfaces]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7632</guid> <description><![CDATA[Join me, Leonard (Leo) Eisner, the "IEC 60601 Guy", in a conversation with Subhi Saadeh of Combinate Podcast as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148 ]]></description> <content:encoded><![CDATA[ <p> </p> <figure class="wp-block-image size-full is-resized"><img fetchpriority="high" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner.jpeg" alt="" class="wp-image-7634" width="1218" height="1218" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner.jpeg 540w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner-300x300.jpeg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner-150x150.jpeg 150w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner-270x270.jpeg 270w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner-230x230.jpeg 230w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner-45x45.jpeg 45w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner-100x100.jpeg 100w" sizes="(max-width: 1218px) 100vw, 1218px" /></figure> <p>Join me, <a href="https://www.linkedin.com/in/ACoAAABI0MQBuOSm1PL6Rtb3VTU5ORFgMiOgnQ0"></a><a href="https://www.linkedin.com/in/leoeisnersafetyconsultants/" target="_blank" rel="noreferrer noopener">Leonard (Leo) Eisner</a>, the “IEC 60601 Guy”,<br><br>in a conversation with <a href="https://www.linkedin.com/in/ACoAAASYqiIBwAoA_1K9vXX-snW26Y7H7REb9kk"></a><a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi Saadeh</a> of <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a><br><br>as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a> 148 <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">https://bit.ly/LIPostCombinatePodcast148LeoEisner</a></p> <p>He really does his research and is a great interviewer. I always find it fun and intriguing to have a conversation with <a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi</a> as I too learn from our conversations.</p> <p>We discuss:<br>☞ complexities in assessing applicable standards<br>☞ understanding the impact of product environment, intended use, & applicable markets<br>☞ challenges and strategies for documenting standards assessments<br>☞ leveraging existing standards to avoid unnecessary development<br>☞ tips for small and large companies<br>☞ significance of early research<br>☞ essential stakeholders involved in standards assessment<br>☞ and more….</p> <p>Join us <img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1faf5.png" alt="🫵" class="wp-smiley" style="height: 1em; max-height: 1em;" /> in the conversation on <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">LinkedIn</a> and <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">leave your comments</a> so we can <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">continue this discussion</a>. </p> <p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">sits on many standards committees</a>. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. </p> <p>We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.</p> <p>Feel free to <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p> ]]></content:encoded> </item> <item> <title>Standards: Explosion and Challenges Maintaining/Updating</title> <link>https://eisnersafety.com/2024/04/18/standards-explosion-and-challenges-maintaining-updating%ef%bf%bc/?utm_source=rss&utm_medium=rss&utm_campaign=standards-explosion-and-challenges-maintaining-updating%25ef%25bf%25bc</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Thu, 18 Apr 2024 03:09:22 +0000</pubDate> <category><![CDATA[13485]]></category> <category><![CDATA[14971]]></category> <category><![CDATA[15223-1]]></category> <category><![CDATA[20417]]></category> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1, 4th edition]]></category> <category><![CDATA[62304]]></category> <category><![CDATA[62366]]></category> <category><![CDATA[62366-1]]></category> <category><![CDATA[Active Implants]]></category> <category><![CDATA[AI]]></category> <category><![CDATA[Apr 2024]]></category> <category><![CDATA[Auditing]]></category> <category><![CDATA[Combination Device]]></category> <category><![CDATA[Combination Product]]></category> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[Essential Performance]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Guidance Documents]]></category> <category><![CDATA[Harmonized Standards]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[ISO 13485]]></category> <category><![CDATA[ISO 15223-1]]></category> <category><![CDATA[ISO 20417]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[Machine Learning]]></category> <category><![CDATA[MDD]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[Notified Bodies]]></category> <category><![CDATA[Quality Assurance]]></category> <category><![CDATA[Recognized Consensus Standards]]></category> <category><![CDATA[Regulation]]></category> <category><![CDATA[Regulatory Affairs]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[SaMD]]></category> <category><![CDATA[Software]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards Development]]></category> <category><![CDATA[US]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7518</guid> <description><![CDATA[Standards: Explosion and Challenges Maintaining/Updating My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.]]></description> <content:encoded><![CDATA[ <figure class="wp-block-image size-large"><a href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank" rel="noopener"><img decoding="async" width="1015" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-1015x1024.png" alt="" class="wp-image-7520" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-1015x1024.png 1015w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-297x300.png 297w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-150x150.png 150w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-768x775.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-45x45.png 45w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-600x606.png 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-100x100.png 100w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM.png 1300w" sizes="(max-width: 1015px) 100vw, 1015px" /></a></figure> <p> My conversation with <a href="https://www.linkedin.com/in/ACoAAASYqiIBwAoA_1K9vXX-snW26Y7H7REb9kk"></a><a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi Saadeh</a> of <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a> was very intriguing and he does a fun podcast. Check out the <a rel="noreferrer noopener" href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" data-type="URL" data-id="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank">podcast</a> as I talk about Standards.</p> <p>We covered a lot of ground in a short time (it flew by for me – I’m sure it will for you too) and if you compare him to an architect he would build something similar to the Louvre Museum with its very unique but beautiful peaks and valleys with surprises around every corner. The Lourve is recent in my mind as I was at an <a rel="noreferrer noopener" href="https://bit.ly/ParisISOTC210WG2WG3" data-type="URL" data-id="https://bit.ly/ParisISOTC210WG2WG3" target="_blank">ISO TC 210 standards meeting in Paris Dec ’23</a> and visited the Louvre. One of my many travels around the world in support of standards development over the last 20 years.</p> <figure class="wp-block-image size-large"><img decoding="async" width="768" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-768x1024.jpg" alt="" class="wp-image-7522" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-768x1024.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-225x300.jpg 225w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-1152x1536.jpg 1152w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-1536x2048.jpg 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-600x800.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-scaled.jpg 1920w" sizes="(max-width: 768px) 100vw, 768px" /></figure> <p>He really does his research. He found my old reconnaissance standards database I was planning to publish but never did. That was a total surprise. </p> <p>We dive right into standards in many ways that you may not have thought of before in <a rel="noreferrer noopener" href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" data-type="URL" data-id="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank">Podcast</a> :<br>☞ The explosion of standards vs no standards (or chaos of no standards)<br>☞ The impact of standards on medical device development<br>☞ Standards and Regulatory Challenges<br>☞ My Notified Body Auditing Experience, Authorization Process, Product Reviewer<br>☞ The Challenges of Maintaining and Updating Standards</p> <p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">sits on many standards committees</a>. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. </p> <p>We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.</p> <p>Feel free to <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p> ]]></content:encoded> </item> <item> <title>FDA EMC IVD Standards Analysis</title> <link>https://eisnersafety.com/2022/02/20/fda-emc-ivd-standards-analysis/?utm_source=rss&utm_medium=rss&utm_campaign=fda-emc-ivd-standards-analysis</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Sun, 20 Feb 2022 18:38:18 +0000</pubDate> <category><![CDATA[61326]]></category> <category><![CDATA[61326-1]]></category> <category><![CDATA[61326-2-6]]></category> <category><![CDATA[EMC]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Feb 2022]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[Recognized Consensus Standards]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7163</guid> <description><![CDATA[On December 20, 2021 the FDA Released their Recognition List Number 057 through their online db. With that publication of list 057 two, EMC IVD standards were added to the list. But the FDA only Partially Recognized IEC 61326-1:2020 and]]></description> <content:encoded><![CDATA[ <figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/lab-equipment-IVD-1024x685.jpeg" alt="" class="wp-image-7172" width="1218" height="815" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/lab-equipment-IVD-1024x685.jpeg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/lab-equipment-IVD-600x401.jpeg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/lab-equipment-IVD-300x201.jpeg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/lab-equipment-IVD-768x514.jpeg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/lab-equipment-IVD-1536x1028.jpeg 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/lab-equipment-IVD.jpeg 2000w" sizes="auto, (max-width: 1218px) 100vw, 1218px" /></figure> <p>On December 20, 2021 the FDA Released their Recognition List Number 057 through their online db. With that publication of list 057 two, EMC IVD standards were added to the list. <br>But the FDA only <span style="text-decoration: underline;">Partially Recognized</span> <strong>IEC 61326-1:2020</strong> and <strong>IEC 61326-2-6:2020</strong>.<br>What does that mean to IVD EMC tests?<br>We have done a detailed analysis that has been confirmed by FDA’s EMC experts to let you know what EMC tests you need to conduct in order to meet both FDA and EU requirements for IVD equipment.</p> <figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Screen-Shot-2022-02-19-at-2.49.36-PM-1-1024x284.png" alt="" class="wp-image-7169" width="1046" height="290" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Screen-Shot-2022-02-19-at-2.49.36-PM-1-1024x284.png 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Screen-Shot-2022-02-19-at-2.49.36-PM-1-600x167.png 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Screen-Shot-2022-02-19-at-2.49.36-PM-1-300x83.png 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Screen-Shot-2022-02-19-at-2.49.36-PM-1-768x213.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Screen-Shot-2022-02-19-at-2.49.36-PM-1-1536x427.png 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Screen-Shot-2022-02-19-at-2.49.36-PM-1-2048x569.png 2048w" sizes="auto, (max-width: 1046px) 100vw, 1046px" /></figure> <p>If you have IVD devices that you are submitting to the FDA you will need to be aware of these requirements. Rely on our experts for this analysis. We have had discussions with the FDA to understand the issues so we can explain this information.</p> <p><a href="https://eisnersafety.com/fda-emc-ivd-analysis/" data-type="page" data-id="7110">Click here</a> to link to the order page.</p> ]]></content:encoded> </item> <item> <title>Regulatory Updates – January 2022</title> <link>https://eisnersafety.com/2022/01/31/regulatory-updates-january-2022/?utm_source=rss&utm_medium=rss&utm_campaign=regulatory-updates-january-2022</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Mon, 31 Jan 2022 06:24:47 +0000</pubDate> <category><![CDATA[Active Implants]]></category> <category><![CDATA[Brexit]]></category> <category><![CDATA[Combination Product]]></category> <category><![CDATA[Computational Modeling]]></category> <category><![CDATA[Computational Simulation]]></category> <category><![CDATA[Designated Standards]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[Draft Guidance]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Final Guidance]]></category> <category><![CDATA[Guidance Documents]]></category> <category><![CDATA[Hamonised Standards]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[IVDR]]></category> <category><![CDATA[Jan 2022]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[Patient Engagement]]></category> <category><![CDATA[Patient Reported Outcome Instruments for Use in Medical Device Evaluation]]></category> <category><![CDATA[Physiologic Closed-Loop Control]]></category> <category><![CDATA[Recognized Consensus Standards]]></category> <category><![CDATA[Reprocessing]]></category> <category><![CDATA[Scotland]]></category> <category><![CDATA[Software]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[UDI]]></category> <category><![CDATA[UK]]></category> <category><![CDATA[Wales]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7051</guid> <description><![CDATA[Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world]]></description> <content:encoded><![CDATA[ <figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/Worldflatimage500x350-72dpi.jpg" alt="" class="wp-image-7054" width="590" height="413" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/Worldflatimage500x350-72dpi.jpg 500w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/Worldflatimage500x350-72dpi-300x210.jpg 300w" sizes="auto, (max-width: 590px) 100vw, 590px" /></figure> <h3 class="wp-block-heading" id="mini-index">Regulatory Update – January 2022 Index</h3> <p>I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world as needed – Enjoy and let me hear your feedback on Linked for this post.</p> <ol class="wp-block-list"><li><a href="#FDA-Recognized-Stds-LIst-057">FDA Updates Recognized Consensus Standards db with List 057</a></li><li><a href="#FDA-Guidance-docs-issued-recently-drafts-&-finals">FDA Guidance documents Issued – Final and Drafts Recently</a></li><li><a href="#EC-Harmoised-Standards-Webiste-for-MDR-&-IVDR">EC Has Finally Set-Up a Harmonised Standards Website for MDR & IVDR</a></li><li><a href="#UK-Designated-Stds-for-Med-Dvcs-Active-Implants-&-IVDs-Published">UK Designated Standards for Medical Devices, Active Implants, and IVDs published</a></li></ol> <h3 class="wp-block-heading" id="FDA-Recognized-Stds-LIst-057"><strong><em>FDA Updates Recognized Consensus Standards db with List 057</em></strong></h3> <p>Read the <a href="https://www.federalregister.gov/documents/2021/12/09/2021-26635/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized" target="_blank" rel="noreferrer noopener" aria-label="Federal Register Notice for the modification of list 056 on 9 Dec 2021 (opens in a new tab)">Federal Register Notice for the modification of list 056 on 9 Dec 2021</a> to see specifically which standards were withdrawn (you can’t see that detail on the db as withdrawn standards are not shown on the db). The ones that are transitioned and the transition periods are noted but only for the transition period so it is always good to review the Federal Register Notices to understand the full picture in my humble opinion. </p> <p>Download the table with the list 057 Recognized Consensus Standards for the full list of standards that were updated on this latest update.</p> <div class="wp-block-file"><a href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/FDA-Recognized-Consensus-Stds-List-057-Dec-20-2021-2.pdf" target="_blank" rel="noreferrer noopener">FDA Recognized Consensus Stds List 057 Dec 20 2021</a><a href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/FDA-Recognized-Consensus-Stds-List-057-Dec-20-2021-2.pdf" class="wp-block-file__button" download>Download</a></div> <p>Or you can go to the <a rel="noreferrer noopener" aria-label="FDA's Recognized Standards db (opens in a new tab)" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm" target="_blank">FDA’s Recognized Standards db</a> and search for 12/20/2021 to 12/20/2021 Publication date range to see the 90 standards that are part of the List 057 updates (some are just version changes, some are new standards – See the Federal Register Notice above)</p> <p><a href="#mini-index">Back to top</a></p> <h3 class="wp-block-heading" id="FDA-Guidance-docs-issued-recently-drafts-&-finals"><em><strong>FDA Guidance documents Issued – Final and Drafts Recently</strong></em></h3> <p>FDA has been busy with Draft & Final Guidance documents in the last 90 days. I put together a document of some of the more relevant Guidance documents for the medical device industry over the last 90 days. This download includes a Comment column that is a summary of the Guidance (FDA & sometimes my comments added). If the Guidance is a draft I provide the comment link if you would like to send in a comment to the FDA (public or anonymous can be posted), of course the link for the guidance, and more. The Guidances are: 1) Combination Devices (Final), 2) Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, 3) Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, 4) Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, 5) Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology, 6) Referencing the Definition of “Device” in the Federal FD&CA in Guidance… 7) Content of Premarket Submissions for Device Software Functions.<br><br>Download the</p> <div class="wp-block-file"><a href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/FDA-Final-Draft-Guidance-Documents-in-Last-90-Days-as-of-30-Jan-2022.pdf" target="_blank" rel="noreferrer noopener">FDA Final & Draft Guidance Documents in Last 90 Days as of 30 Jan 2022</a><a href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/FDA-Final-Draft-Guidance-Documents-in-Last-90-Days-as-of-30-Jan-2022.pdf" class="wp-block-file__button" download>Download</a></div> <p><a href="#mini-index">Back to top</a></p> <h3 class="wp-block-heading" id="EC-Harmoised-Standards-Webiste-for-MDR-&-IVDR"><strong><em>EC Has Finally Set-Up a Harmonised Standards Website for MDR & IVDR</em></strong></h3> <p>The European Commission overhauled the sectoral website on Medical Devices in now accessible from the <a rel="noreferrer noopener" aria-label=" (opens in a new tab)" href="https://ec.europa.eu/health/index_en" target="_blank">DG SANTE’s Public Health website</a> – a new specific <a rel="noreferrer noopener" aria-label="webpage on Harmonized Standards (opens in a new tab)" href="https://ec.europa.eu/health/medical-devices-topics-interest/harmonised-standards_en" target="_blank">webpage on Harmonized Standards</a> has been set up from the web page <a rel="noreferrer noopener" aria-label=""Medical Devices - Topics of Interest" (opens in a new tab)" href="https://ec.europa.eu/health/medical-devices-topics-interest_en" target="_blank">“Medical Devices – Topics of Interest”</a>, which has some great topics of interest including <a rel="noreferrer noopener" aria-label="Notified Bodies (opens in a new tab)" href="https://ec.europa.eu/health/medical-devices-topics-interest/notified-bodies_en" target="_blank">Notified Bodies</a> (You can find the NBs for both the MDR & IVDR, the codes they are designated under & more info), <a rel="noreferrer noopener" aria-label="UDI (opens in a new tab)" href="https://ec.europa.eu/health/medical-devices-topics-interest/unique-device-identifier-udi_en" target="_blank">UDI</a> (Bountiful resource page), <a rel="noreferrer noopener" aria-label="Reprocessing (opens in a new tab)" href="https://ec.europa.eu/health/medical-devices-topics-interest/reprocessing-medical-devices_en" target="_blank">Reprocessing</a> (Well worth reading to understand where the European Commission and <a rel="noreferrer noopener" aria-label="each country stands on this issue (opens in a new tab)" href="https://ec.europa.eu/health/medical-devices-new-regulations/getting-ready-new-regulations/national-rules-reprocessing-single-use-devices_en" target="_blank">each country stands on this issue</a> currently), <a rel="noreferrer noopener" aria-label="Latest Updates (opens in a new tab)" href="https://ec.europa.eu/health/medical-devices-topics-interest/latest-updates_en" target="_blank">Latest Updates</a> (separate web page), and more. The Harmonisation web page contains the links to the standardization requests in force and to the publications in the OJEU of references of harmonized standards conferring a presumption of conformity in support of the MDR & the IVDR. The page will gradually grow with more publications, and also with future amendments to the standardization request.</p> <p>For the latest lists of the MDR & IVDR Harmonized Standards please go to my <a href="https://eisnersafety.com/2022/01/10/eu-mdr-ivdr-harmonized-standards-lists-updated-9-added-to-mdr-5-to-ivdr/">previous post</a>. Most likely the next update likely to occur March /April 2022.</p> <p>The above information is thx to <a rel="noreferrer noopener" aria-label="Mario Garbielli Cossellu (opens in a new tab)" href="https://www.linkedin.com/in/mariogabriellicossellu/" target="_blank">Mario Garbielli Cossellu</a> a Policy & Legal Officer at the European Commission provides many great updates on the MDR & IVDR. Check out his <a rel="noreferrer noopener" aria-label="recent posts (opens in a new tab)" href="https://www.linkedin.com/in/mariogabriellicossellu/recent-activity/" target="_blank">recent posts</a> there is always some great content to keep up to date on. I’ve been following him for years on <a rel="noreferrer noopener" aria-label="LinkedIn (opens in a new tab)" href="https://www.linkedin.com/" target="_blank">LinkedIn</a>. </p> <p><a href="#mini-index">Back to top</a></p> <h3 class="wp-block-heading" id="UK-Designated-Stds-for-Med-Dvcs-Active-Implants-&-IVDs-Published"><strong><em>UK Designated Standards for Medical Devices, Active Implants, and IVDs published</em></strong></h3> <p>The general <a href="https://www.gov.uk/guidance/designated-standards?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=821d8207-bdb9-4fb8-b2cf-e438be1e20f6&utm_content=daily#healthcare-engineering" target="_blank" rel="noreferrer noopener" aria-label="Designated Standards website (opens in a new tab)">Designated Standards website</a> covers all categories of products, services or processes to comply with essential requirements of the applicable legislation.</p> <p>Within that web page there is information on the <a rel="noreferrer noopener" aria-label="designation process (opens in a new tab)" href="https://www.gov.uk/guidance/designated-standards?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=821d8207-bdb9-4fb8-b2cf-e438be1e20f6&utm_content=daily#the-designation-process" target="_blank">designation process</a>, <a rel="noreferrer noopener" aria-label="reference of designated standards (opens in a new tab)" href="https://www.gov.uk/guidance/designated-standards?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=821d8207-bdb9-4fb8-b2cf-e438be1e20f6&utm_content=daily#references-of-designated-standards" target="_blank">reference of designated standards</a>, and then the different industries, product, and processes. Within that list there is a <a rel="noreferrer noopener" aria-label="Healthcare engineering (opens in a new tab)" href="https://www.gov.uk/guidance/designated-standards?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=821d8207-bdb9-4fb8-b2cf-e438be1e20f6&utm_content=daily#healthcare-engineering" target="_blank">Healthcare engineering </a>section. </p> <p>The 3 important lists are all controlled by the MHRA. They are: </p> <ol class="wp-block-list"><li><a rel="noreferrer noopener" aria-label="Medical Devices (opens in a new tab)" href="https://www.gov.uk/government/publications/designated-standards-medical-devices" target="_blank">Medical Devices</a></li><li><a rel="noreferrer noopener" aria-label="In Vitro Diagnostic Medical Devices (opens in a new tab)" href="https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices" target="_blank">In Vitro Diagnostic Medical Devices</a></li><li><a rel="noreferrer noopener" aria-label="Active Implantable Medical Devices (opens in a new tab)" href="https://www.gov.uk/government/publications/designated-standards-active-implantable-medical-devices" target="_blank">Active Implantable Medical Devices</a></li></ol> <p><a href="#mini-index">Back to top</a></p> <h3 class="wp-block-heading"><em><strong>Need Help?</strong></em></h3> <p>Need help with the UK, EU MDR requirements, IEC 60601 (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" aria-label=" (opens in a new tab)" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to <a rel="noreferrer noopener" aria-label="schedule a call with Leo (opens in a new tab)" href="http://www.EisnerSafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a href="https://eisnersafety.com/contact_eisner_safety/" target="_blank" rel="noreferrer noopener" aria-label="contact form (opens in a new tab)">contact form</a>.</p> ]]></content:encoded> </item> </channel> </rss>