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Will SRNs (EU MDR) issued before May 25?

  • 1.  Will SRNs (EU MDR) issued before May 25?

    Posted 09-Apr-2020 09:27
    Hi - apologies if this has already been discussed. Will SRN's be issued prior to May 25 despite EUDAMED delays? If not, does anyone have insight into when we can expect to get an SRN, and where the process will be captured for how to get one?

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    Allyson Swartz
    Quality Engineer II
    Coralville IA
    United States
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  • 2.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 09-Apr-2020 18:48

    The good news, so far, is that the EUDAMED delay means that economic operators do not need an SRN. Without EUDAMED, Article 123 says to revert to the MDD requirements. The applicable requirements are in MDD Article 14, which does not include an SRN.

    The bad news is that there now a plan to bring up EUDAMED module by module. One of the first modules in the plan relates to Actors which will probably include SRNs. The problem is that when modules come up separately, they create crazy workarounds. For example, MDCG 2019-5 create the ill-formed concepts of a Eudamed DI and a Eudamed ID because the design tightly-coupled some modules, but they come up together.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 10-Apr-2020 03:56
    According to the "Joint Implementation/preparedness plan" published in March 2020 "…an MDCG position paper is under preparation with the aim of explaining the issuing of Single Registration Numbers (SRNs)…". 

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    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
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    Original Message


  • 4.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 10-Apr-2020 10:48
    Hello,

    The short answer is unlikely we will see SRN assignment before the compliance date.  There was some back and forth where EUDAMED would assign, then it was up to the Competent Authorities to assign, now back to EUDAMED.  As already mentioned, until EUDAMED is functional to allow assignment of SRNs to Economic Operators, we have just been putting in our documentation, 'when assigned' or available.  Personally, there are a few things we are waiting for in relation to EUDAMED - so nice to see they are going back to module approach instead of the big bang theory.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 11-Apr-2020 02:28
      |   view attached
    Hi
    MDR has been postponed to 05/2021, so I also expect SRN to be moved as well.
    ----------------

    The Commission will propose a one-year delay for the Medical Device Regulation (MDR) transition deadline, Commission spokesperson Stefan De Keersmaecker said today.

    The Commission is still working on the proposal, De Keersmaecker said, but it aims to have it go to the Council and the Parliament at the beginning of April. De Keersmaecker urged them to adopt it quickly.

    "This will relieve pressure on industry and allow them to focus fully on urgent priorities related to the coronavirus crisis," De Keersmaecker said.
    ---------------------

    also please see EU proposal document in Appendix described as follows

    "The proposal has two aims:
    - to prolong the transitional period that started in 2017 by one year, by postponing from 26 May 2020 to 26 May 2021 the application of most of the provisions of Regulation (EU) 2017/745 and, for the same reason, to defer the repeal of most of the provisions of the two Directives until 26 May 2021."....

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    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
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    Original Message


  • 6.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 11-Apr-2020 08:31

    Actually, the EU-MDR Date of Application, DoA, has NOT been postponed.

    There is a proposal to amend the EU-MDR to change the date of application to May 26, 2021. There is also a proposed amendment to the proposal to amend the EU-MDR.

    As I understand the EU system, three legislative bodies must all pass the same document: the Commission, the Parliament, and the Council.

    The status today, I believe, is that the Commission passed the proposal, and that is the only thing that happened.

    The plan is to have it completed by the end of May 2020. See https://ec.europa.eu/growth/sectors/medical-devices_en



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 7.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 11-Apr-2020 09:34
    Edited by Ary Saaman 11-Apr-2020 09:35
    As far as I have been able to follow, the following currently exists (April 11, 2020) :
    European Commission - April 3, 2020 : Proposal for a Regulation (...) amending regulation (EU) 2017/745 (...)
    Council of the European Union - April 7, 2020 : NOTE - subject : Proposal for a regulation (...) - mandate for negotiation with the European Parliament
    Council of the European Union - April 8, 2020 : NOTE - COR 1, which is a correction to the NOTE issued on April 7, 2020

    As it may be burdensome to find these documents on the EU-website, I have appended them for your perusal.

    As far as I am aware, the European Parliament will vote on the above in its plenary session of April 16, 2020, and the expectation is that a "vast majority" will approve the above.

    To be continued ... .
    Stay safe, a Happy Easter to all of you, and as always with kindest regards,




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    Ary Saaman
    Director, Regulatory Affairs
    Lausanne
    Switzerland
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    Original Message


  • 8.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 11-Apr-2020 14:17
    In addition to my above post, see also the following blog by Erik Vollebregt about the proposal for delaying the EU MDR's DoA  till May 26, 2021.

    https://medicaldeviceslegal.com/2020/04/08/mdr-amendment-proposal-article-120-3-oversight-set-to-be-fixed-by-council/

    Stay safe and all the best,

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    Ary Saaman
    Director, Regulatory Affairs
    Lausanne
    Switzerland
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    Original Message


  • 9.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 12-Apr-2020 08:08
    Sorry for being cynical but don't you think it's just a political show? With only one month to go, any manufacturer who was planning to fully comply with EU MDR would be ready by now, or they would have decided to make use of Art. 120 and also be ready by now, or they would have stockpiled their older products at their distributors. Can you think of a single manufacturer who would actually benefit from this delay?

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    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
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    Original Message


  • 10.  RE: Will SRNs (EU MDR) issued before May 25?

    This message was posted by a user wishing to remain anonymous
    Posted 13-Apr-2020 09:33
    This message was posted by a user wishing to remain anonymous

    Can you think of a single manufacturer who would actually benefit from this delay?

    1- Every single org involved in class 1 accessories / class 1 devices for distribution is celebrating because a vast number of those small mfrs never did a thing to prep until a bigger company who distributes for them got in their face. 

    2- Every mfr involved in urgently increasing demand to up production fir the crisis (vents and more) is already getting allowances for dig changes to MDD certified models as they scramble to add new manufacturing locations, new suppliers, and design mods.  Nearly all sig change to an MDD ought to be frozen right now but absolutely all would be not allowed after may 26 if Mdr went into force, repealing MDD.  

    3- Now imagine how those two scenarios combine when you consider exam gloves/ surgical masks- some of the hottest items most urgently needed.  Imagine if EU MDR went as planned and only served as an obstacle to the global supply of these class 1 devices at this time- pretty unacceptable.  


     


    Original Message


  • 11.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 15-Apr-2020 00:28

    I don't find it unacceptable.  To whom?  And why?

    I do think it's a challenge, but life is full of challenges.  Some stride right through them, others struggle their way through, others just fold.  Those who come out the other side are the stronger and the better for it.  The others remain just folded.

    And here I am once again, teetering uncomfortably on the sharp edge of Hanlon's Razor.  I can't decide if it is worse to think that the EU, and some number of medical device manufacturers, are not up to this challenge, or if they are just using COVID-19 as an excuse to duck out on it.  Or both, sigh.

    I'm also starting to get the discouraging impression that some number of medical device manufacturers would actually not ship supplies that are urgently needed in this pandemic, simply because that might violate some regulation.  (Talk about the difference between compliance and regulatory, there you have it.)  If I were queen of the world, I'd immediately make it illegal to manufacture, sell, or distribute ventilators, masks, gloves, and gowns.  Then we would see what this industry is made of.

    On a more practical note, I think any company that is still scrambling to add new manufacturing locations, new suppliers, and design modifications has missed this pandemic already.



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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 12.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 14-Apr-2020 02:06
    Edited by Julie Omohundro 15-Apr-2020 00:30
    Not the least bit sorry for being cynical. :)

    If it is a political show, who is it for and what is its purpose?  I don't pretend to understand EU politics (US is more than enough), but if this were happening in the US, it would be for one of two reasons:

    1) Congress and/or FDA caved to pressure from industry. 

    I can see that happening in the EU, too, but in this case, I would expect all the companies with political clout to be fully behind keeping with the present deadline, since, as far as I can tell, this serves their interests as much as anyone's.  They should be ready and looking forward to expanding their market share, due to smaller players being forced from the market.

    2) FDA isn't ready.

    I have not figured out whether the EU is ready or not, because of all the people eagerly seizing on every little hiccup as a reason to delay. Clearly it was never necessary to have Eudamed up and running, for all the legions of people who tried to insist otherwise.  As for guidances, they are helpful, but not necessary.  In any case, the EU seems to have published a bookcase full in recent months.

    Beyond that, FDA has a lot of leeway on these things; I have been assured many times that the EU has none. Since I am not only cynical, but also skeptical, I never accepted these assurances as facts, but I was inclined to think that, at the very least, it was not something the EU could just decide to up and do because it felt like it.  Now it seems that is the case.

    As for your last question, I think manufacturers who were not planning to comply with the MDR will benefit.  I think manufacturers who can't figure out how to get through this without the EU throwing down its coat, taking them by the hand, and gently guiding them across the MDR puddle think they will benefit.  I think that this is something that remains to be seen.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 13.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 13-Apr-2020 03:28
    The decision of moving the enforcement of MDR to 2021 WILL be voted. There is not doubt about that (i can still some people in the forum having hopes about that).
    This is not an MDR delay, but an extension of the MDD. You can go with MDR if you like. There are designated NBs.

    In any case, I do not see having SRN before May 2021. But I believe that we will actually have SRN before EUDAMED. They will find a way to generate these numbers. When EUDAMED is live, all the certified products must be inducted to EUDAMED. What happens if they do not have a SRN?

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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    Original Message


  • 14.  RE: Will SRNs (EU MDR) issued before May 25?

    Posted 15-Apr-2020 01:19
    Edited by Julie Omohundro 15-Apr-2020 01:20

    I'm not much of a hoper.  However, for almost a decade now I have been looking forward to finding out whether the EU was really going to step up its game or not.  I am excited to think that, atfer all these years, I might finally get an answer to this long-standing question tomorrow.

    Rather than hoping the EU would step up, I have always been inclined to think it would not, maybe even cannot, but I like to keep an open mind.  Anything can happen.  That said, I would certainly love to see the EU step up.  I don't want CDRH to be first in the world due to lack of competition.  I don't want a CE Mark to mean little to anyone on a device that has also been FDA whatevered. But I would still love to see "an-end-to-world-hunger-and-peace-in-our-time," and I never had any hope of seeing those, either.

    In any case, if the EU doesn't have what it takes to stand firm on the date that the MDR goes fully into force (perhaps the easiest of all the things it would have to do, COVID-19 or no COVID-19, to really step up), then all doubt will be removed as far as I'm concerned.  The EU is not going to be stepping up, because it doesn't have what it would take.  I'm sure a lot people will continue to hope that it will/can still step up, in spite of the caving, but not me.



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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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