DATELINE 27 MAY 2021 (I will be adding some links below as I go as well): Wow! Some companies made it just across the line in time and I’m sure some didn’t. Did you? Not everyone agress with my perspective. Let’s get on with the story.

What does that all mean?

The MDD and AIMDD are dead (Dead on Arrival) and the MDR Date of Application (DoA) has just flown by us, yesterday. So, we are past the transition period, per say, for the MDR and now we’re into a grace (grey zone) for the legacy MDD/AIMDD products that can’t have any significant changes under their existing MDD/AIMDD certificates otherwise they need to go “full up” into MDR-land.

But wait there is more. All medical devices that are still certified by a Notified Body to the MDD & AIMDD with a valid CE certificate that can expire as late as May 26, 2024 have to comply with certain MDR requirements now which are based on Article 120(3) of the MDR. These requirements include: post-market surveillance, market surveillance, vigilance, and registration of economic operators or operators & of devices. Expect your Notified Body will be auditing you for these items.

On 26 May 2021 there were a lot of blog posts on the subject of MDR DoA, Article 120(3), Swexit, Turkxit, and so much more around this so rich subject so as a present to you I’m going to point you to some of my favorite resources and authors and some additional resources of interest that you may want to review:

Happy MDR DoA and Swixit / no Turkxit day! medicaldeviceslegal – Thx Erik Vollebregt for always explaining the nitty gritty of the MDR / MDD / AIMDD/ IVDD / IVDR to us. As a bonus I am adding LinkedIn post from Erik as well. You never know where the conversations may end up but they are always interesting.

D-0 MDR Day Monir El AAzzouzi of Easy Medical Device LinkedIn Post. Monir provide some great resources on MDR in the form of pdocasts and other training tools including blog posts. He recruits some of the best minds for his podcasts/webinars LinkedIn Posts, etc. He is quite the social media mogul.

And we are live! The MDR Hurdle race is on! Qserve Group – This podcast series is an excellent resource – I have known Gert for many years now. He is one of the heads of Qserve and has many years of Notified Body & Team NB expertise prior to joining Qserve. We have cooperated on some standards development work.

MDR’s Day One: Experts weigh in RAPS – RF News in FOCUS Series. Society for Regulatory Professionals. Has many good resources and growing. RAPS Regulatory Exchange is a great resource to exchange ideas and gain new information (you have to be a member to use this resource).

Important LinkedIn Posts from Mario Gabrielli Cossellu (Policy and Legal Officer at European Commission):

• Meetings of the MDCG 27 – 28 May 2021 takes place
• Updates to the NANDO db of Notified Bodies related to MDD & AIMDD transitional provisions of Article 120of MDR & note able to issue new certificates for MDD & AIMDD
• EC’s Q&A
• EC Press Release 26 May 2021 “Public health: Stronger rules on medical devices”
• Today is MDR Day

EU MDR Date of Application roundup: EMDN, eIFUs, UDI helpdesk, clinical investigation EMERGO by UL – This article is a summary of various items they are rounding up information on for the MDR but not specific to DoA issues.

Questions & Answers: Application of Regulation on Medical Devices – EU rules to ensure safety of medical devices Direct from the European Commission as of 26 May 2021.

NOTICE TO STAKEHOLDERS: STATUS OF THE EU-SWITZERLAND MUTUAL
RECOGNITION AGREEMENT (MRA) FOR MEDICAL DEVICES Notice from the European Commission on the Status of the EU – Switzerland MRA for Medical Devices.

Join the conversation on LinkedIn and add comments to the conversation there.

Confused by the MDR? 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/.

Heads Up! – Updated 24 May 2021

Written by Bill Hardin and Leo Eisner

Thx for all the great support from the LinkedIn, RAPS Forum, the standards and test lab communities that have provided feedback on this post.  Turns out with all the good feedback we got from these communities we need to update this post as CISPR 11 Group 2 intentional radiators was included in the previous edition but you really need to be aware of RFID requirements.

The FDA has been insisting that medical device, IVD and even implanted medical device manufacturers meet AIM 7351731 RFID immunity testing as part of their 510k/PMA submissions.  This test is onerous since it includes RF immunity at levels of up to 54V/m, nearly twice the field strength (28V/m) that the IEC 60601-1-2 table 9 requires, and would often result in design changes to increase RF immunity.

From AIM 7351731:

IEC 60601-1-2:2020, edition 4.1, got fast tracked by the FDA since it contains new immunity tests (table 11 – RFID requirements based on AIM 7351731 standard values) that they want manufacturers to do before submitting. The FDA has been accepting the IEC 60601-1-2:2020 table 11 test in lieu of AIM 7351731 testing, which is very good news as there are only two AIM 7351731 frequencies to be tested instead of all the test frequencies and test levels of Table 3 of the AIM 7351731 standard.

This 2020 version of IEC 60601-1-2 is still about three years out from taking effect in EU (with no grandfathering allowed) unless your Notified Body may expect ‘State of the Art’ in a shorter time period (some do require this) or your company will go with ‘State of the Art’ which is a requirement of the EU MDR 2017/745 Annex I, Items 1 & 4, and per MDCG 2021-5, but FDA went first by Recognizing the standard at the end of 2020.

This blog previously erroneously stated that CISPR 11 Group 2 radiated emission limits had changed as part of the transition to IEC 60601-1-2:2020. They have not changed. So no redesign is needed for that but you still may need to redesign your product based on the RFID requirements.

Join the conversation on LinkedIn and add comments to the conversation there.

Confused by these EMC, standards or regulatory issues? This is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner is an expert on standards development and sit on many standards committees. Bill Hardin is an EMC expert and a design expert that can help you thru the design process. Let us help you through this process. Need help with Essential Performance. 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/.

In my last post on this Standardization Request I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request to be accepted even if not perfect. Which it did. So, yes congratulations it passed but will we be able to get anything out of this document? Let’s hope, even though I’m not so hopeful if you read my last post.

So, officially we have a basis for the harmonization of the listed standards (Annex I & II) in the Standardization Request for the MDR and IVDR with CEN and CENELEC accepting the Request. The Policy Officer at the EC dealing with this is Mario Gabrielli Cossellu and he stated “This is the legal basis now in force to start publications in the OJEU of references of Harmonised Standards to confer presumption of conformity with the legal requirements of the Regulations. The first lists should be ready by June 2021 and periodically updated and enlarged.”

Now the BIG QUESTION is will Annex III of the Standardization Request be able to be met for any of the Standards that are to be Harmonized and will we ever get any Harmonized Standards for the MDR & IVDR?

In Annex III there are multiple examples:

For the “legal requirements to be supported by the harmonised standards”:

“Where a definition in a harmonised standard differs from a definition of the same term set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746, the differences shall be indicated in the foreword of that standard and in its Annex Z. That Annex shall also state that, for the purpose of using the standard in support of the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746, the definitions set out in those Regulations prevail.”

For the “Reduction of Risk”:

“The specifications of harmonised standards concerning the reduction of risk which may be associated with the device shall take into account the general requirements laid down in point 2 of Chapter I of Annex I of the MDR or IVDR to reduce risks as far as possible without adversely affecting the benefit-risk ratio.“

For the “Normative References”:

It’s a bloody mess and it would be hard to just repeat it all here so just look at it on your own. Realize a normative reference is a requirement whereas an Informative reference is optional and more for your information. So, in Annex III refer to Item 4.

There is more but I’m not going to continue as this sets the scene of the crime as you can plainly see by now.

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Confused this is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner is an expert on standards development and sit on many standards committees. Let us help you through this process. Need help with Essential Performance. 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/.