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the Federal Register Notice for the modification of list 056 on 9 Dec 2021 to see specifically which standards were withdrawn (you can’t see that detail on the db as withdrawn standards are not shown on the db).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

The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746
on 5 January 2022 and 7 January 2022
amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195
all above references are respective for the MDR and IVDR (1st MDR & 2nd IVDR)

MDR Harmonization

The addition of 9 new Harmonized Standards for the MDR including EN ISO 13485:2016/A11:2021 and EN ISO 15223-1:2021 are both finally added but unfortunately EN ISO 14971:2019/A11:202X wasn’t added. Hopefully, EN ISO 14971:2019/A11:202X should be added around March or April per Mario Gabrielli Cossellu.

I was really surprised by the Harmonization of EN IEC 60601-2-83:2020/A11:2021 as the base standard EN IEC 60601-1:2020/A11:202X was not included and none of the collateral standards (EN IEC 60601-1-XX) either. Add in the particular standards (EN IEC 60601-2-XX or EN IEC/ISO 80601-2-XX) that weren’t included which add in 70 standards in the series plus other applicable standards you are talking about a lot of standards just for medical electrical standards.

So, with these 9 new additions to the MDR list of Harmonized standards, there are now 14 references of Harmonized Standards in support of the MDR. A consolidated list for information purposes should be made available soon (per Mario Gabrielli Cossellu) on the harmonized standardization page for Medical devices – Regulation (EU) 2017/745.

Below is the list of the 9 new Harmonized Standards added to the MDR.

IVDR Harmonization

The addition of 5 new Harmonized Standards for the IVDR added the same two key standards EN ISO 13485:2016/A11:2021 and EN ISO 15223-1:2021 but unfortunately EN ISO 14971:2019/A11:202X wasn’t added. So, as mentioned as above we hope the EN ISO 14971 standard will be added on the next round of Harmonization of Standards for the MDR & IVDR. So, with these 5 new additions to the IVDR list of Harmonized Standards, there are now 9 references of Harmonized Standards in support of the IVDR. As mentioned previously a consolidated list for information purposes should be made available soon on the horizontal standardization page for In vitro diagnostic medical devices – Regulation (EU) 2017/746.

Below is the list of the 5 new Harmonized Standards added to the IVDR.

Past Prediction of EU Harmonization Process

I wrote an article for Med Device Online back in July 2019 for “Will We Have Harmonized Standards By The MDR’s Date Of Application?” I predicted pretty much from my pessimistic viewpoint, at that time, and of course now, that there was no way a significant amount of the Harmonized Standards for either regulation would be Harmonized through this process in time for the Date of Application back on May 26 of 2021. Now, six months later, past the DoA and we only have a handful of Harmonized Standards.

So, what is a manufacturer to do?

The safe and easy route is to follow what is in MDCG 2021-5 Guidance on standardisation for medical devices. From the “word on the street” most Notified Bodies will be following this Guidance. Section 3.5 of MDCG 2021-5 discusses the concept of “state of the art”… in detail and gets into the legal details. There is no legal status for “state of the art” but the term is noted in the GSPRs of Annex I of both the MDR & IVDR as noted … “taking into account the generally acknowledged state of the art.” The bottom line that I tell all my clients is you want to design using most recent standards to “State of the Art” and prepare all your Technical Documentation as will always will benefit you in the long run when you submit not only to your EU Notified Body but other National regulators around the world. They will expect you are using the latest standards out there which are related to “Stae of the Art”.

Need Help?

Need help with the 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 asking 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. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com or through our contact form at https://eisnersafety.com/contact_eisner_safety/.