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 as needed – Enjoy and let me hear your feedback on Linked for this post.

1. FDA Updates Recognized Consensus Standards db with List 057
2. FDA Guidance documents Issued – Final and Drafts Recently
3. EC Has Finally Set-Up a Harmonised Standards Website for MDR & IVDR
4. UK Designated Standards for Medical Devices, Active Implants, and IVDs published

FDA Updates Recognized Consensus Standards db with List 057

Read the Federal Register Notice for the modification of list 056 on 9 Dec 2021 to see specifically which standards were withdrawn (you can’t see that detail on the db as withdrawn standards are not shown on the db).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.

Download the table with the list 057 Recognized Consensus Standards for the full list of standards that were updated on this latest update.

Or you can go to the FDA’s Recognized Standards db 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)

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FDA Guidance documents Issued – Final and Drafts Recently

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.

Download the

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EC Has Finally Set-Up a Harmonised Standards Website for MDR & IVDR

The European Commission overhauled the sectoral website on Medical Devices in now accessible from the DG SANTE’s Public Health website – a new specific webpage on Harmonized Standards has been set up from the web page “Medical Devices – Topics of Interest”, which has some great topics of interest including Notified Bodies (You can find the NBs for both the MDR & IVDR, the codes they are designated under & more info), UDI (Bountiful resource page), Reprocessing (Well worth reading to understand where the European Commission and each country stands on this issue currently), Latest Updates (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.

For the latest lists of the MDR & IVDR Harmonized Standards please go to my previous post. Most likely the next update likely to occur March /April 2022.

The above information is thx to Mario Garbielli Cossellu a Policy & Legal Officer at the European Commission provides many great updates on the MDR & IVDR. Check out his recent posts there is always some great content to keep up to date on. I’ve been following him for years on LinkedIn.

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UK Designated Standards for Medical Devices, Active Implants, and IVDs published

The general Designated Standards website covers all categories of products, services or processes to comply with essential requirements of the applicable legislation.

Within that web page there is information on the designation process, reference of designated standards, and then the different industries, product, and processes. Within that list there is a Healthcare engineering section.

The 3 important lists are all controlled by the MHRA. They are:

1. Medical Devices
2. In Vitro Diagnostic Medical Devices
3. Active Implantable Medical Devices

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Need Help?

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. Leo Eisner 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 schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

EU Commission promised 20 Designations

12 Notified Bodies Designated to MDR (9) & IVDR (3*)

*All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective.

2 NB’s are likely to be “de-designated” (not sure of the proper term yet) end of Jan 2020 based on Brexit. That would be BSI Assurance UK Ltd.

The EU Commission has promised more NB’s to be designated in the 1st quarter of 2020. Let’s hope this will get us to at least 20 NB’s.

Two last-minute Christmas presents were BSI Group Netherlands IVDR and Medcert’s MDR designations on 24 & 25 Dec respectively.

Few products have been CE marked to the MDR that have gone through a NB review process. Typically the process is taking at least a year or more. Your quality system and product files need to be reviewed.

You are running out of time with the transition only about 5 months away.

Not all NB’s have full coverage of the NANDO codes so check the NANDO database (MDR link) or check with your NB.

May you have a Happy, Safe, & Prosperous New Year and may your medical device be CE Marked under the MDR in the New Year.