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EU-MDR Harmonized Standards

  • 1.  EU-MDR Harmonized Standards

    Posted 25-Jul-2021 12:10
    It appears there are now some standards harmonized to the EU-MDR. 

    See Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

    https://eur-lex.europa.eu/eli/dec_impl/2021/1182/oj

    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------


  • 2.  RE: EU-MDR Harmonized Standards

    Posted 26-Jul-2021 08:07
    Hi Dan,

    Thanks for posting this, I saw this come across the news feed and glad to see a start - if only 5 standards we can hopefully see this list get bigger so the whole "follow harmonised standards?" question is no longer such a big question.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: EU-MDR Harmonized Standards

    Posted 26-Jul-2021 09:05

    As I published on LinkedIn, Dan, some of the obstacles on getting EN ISO 14971:2019 harmonized have been overcome. It is expected that a European-only amendment to the standard will be published for Harmonization but not immediately.


    It will not contain any content deviations but a Correspondence Table in each of the Z Annexes published, a ZA for MDR and a ZB for IVDR.

    Hopefully it will be published sooner than later, as so many other standards have it as normative references, which will be obstacles to their harmonization. 



    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------

    Original Message


  • 4.  RE: EU-MDR Harmonized Standards

    Posted 26-Jul-2021 09:52
    Edited by Mark Swanson 26-Jul-2021 09:53
    Hoping for a similar outcome for EN ISO 13485. The Z annexes have been drafted for some time. The time has come for the gates to open and harmonized standards to flood forth. Looking forward to the ride!

    ------------------------------
    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
    ------------------------------

    Original Message


  • 5.  RE: EU-MDR Harmonized Standards

    Posted 27-Jul-2021 11:35
    Don't have the same perspetive on the EN 60601 series of standards but would be soooo nice to see if possible.  They are reliant on the EN ISO 14971 but the Particulars (60601-2-XX or 80601-2-XX) are mostly older versions that are connected with ISO 14971:2007 not ISO 14971:2019.  All the Collaterals of the EN  standards have all been updated thru CENELEC last summer and it looks like all but the EN 60601-1 (general std) are close to being approved for ESO publication or some have (European Standards Organization as CENELEC doesn't publish any standards).

    CENELEC approval is not the same as Harmonization, which is confusing for a lot of manufacturers because the standard has the same identification (i.e. EN 60601-1) just the list from EU OJ list is different is the only difference from a front facing perspective.  I know the Annex Z's and how described in the standard are the other indicators but not all manufacturers are that savoy to realize that, dare I say that.

    All for now,

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 6.  RE: EU-MDR Harmonized Standards

    Posted 29-Jul-2021 07:58
    Good to know, thanks for sharing! Hope the list will be expanded soon.

    Best regards,
    Marina

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    Marina Daineko
    Newtown PA
    United States
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    Original Message


  • 7.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 12:16
    Bumping this thread to see if this has been updated?

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 8.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 13:23
    For the EU-MDR the current version is Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

    See https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 9.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 13:46
    In a Working Group meeting last week, it was mentioned that the European HAS consultants' objections regarding the text of EN ISO 14971:2019 have been resolved and/or rebutted, and that the Annexes Z are being drafted in preparation for harmonization.  I'm estimating that this means we'll see EN ISO 14971 finally harmonized via published OJ reference in 2022.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 10.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 13:57

    The status of EN ISO 14971:2019/prA11 Medical devices - Application of risk management to medical devices (ISO 14971:2019) as shown in the database is Approved.

     

    The following dates apply:

    date of Ratification (DOR) (1)            2021-10-27

    date of Availability (DAV) (2)           2021-12-01

     

    As I understand the process, the next step is Published. At that point, we can see the Z annexes.

     

    Following that step, is harmonization, which, presumably, will the next regular update after Published.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 11.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 14:22
    Dan,

    Glad to see you found the notice.  The vote closed 10/26 and I have been watching for the announcement.  The publication date of 12/1 is designed to make the next Harmonization listing in the OJEU by year end.  Both EN ISO 13485:2016 A11:2021 and EN ISO 14971:2019 A11:2021 are expected to be on that list.  The EN 13485 was published in September and is currently available from the European standards suppliers with the Z Annexes (and from BSI it has an NZ for UK Regulations).  

    The next Harmonization listing is expected in the OJ before year end.  I will be presenting a program at AAMI on December 15th on the content of the Amendment to the EN ISO 14971:2019 standard.  The program is currently available for registration at AAMI course registration 

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------

    Original Message


  • 12.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 14:25
    Corrected link is:Corrected Registration

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------

    Original Message


  • 13.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 14:03
    The Harmonized Standards List is expected to be published in the OJEU in December.  Two important horizontal standards should be in that list, one is EN ISO 13485:2016 A11:2021, which has already been published by CEN (and released to the standards suppliers in the EU), but has not appeared in the OJEU.  The Official Journal is expected to be published only twice per year, with December being the next list.  EN ISO 14971:2019 A11:2021 is supposed to be published by CEN shortly.  It will be the candidate for Harmonization and if the timing is right it will appear on the next list.  Still "if's" but it is rapidly moving now, so we should be seeing the final standard soon.    Hopefully, 2021, and not 2022, Kevin.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------

    Original Message


  • 14.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 14:25
    I would be pleasantly, yet very, surprised if a reference to EN ISO 14971 is published in the December 2021 OJ.  I'll keep my fingers crossed Ed (Bills) based on your confidence that the remainder of the harmonization process would be finished in the coming weeks in time for a reference to be published in the December 2021 OJ.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 15.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 14:31
    Thanks all. We are waiting for a slot for our MDR Application so trying to keep our documents correct is no easy task.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 16.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 14:39
    Sounds promising Ed Bills.  Now I'm keeping at least three or four fingers crossed.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 17.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 16:57

    Kevin,

    With all this uncertainty that has crept into this process, you haven't also wanted to cross all your toes & nose too??? ha ha.
    Glad things are finally moving somewhat.
    But the main point that I think many agree on, I hope, is that no matter what use the most current versions of standards even if not Harmonized is most of the times the best solution. There is always an exception to the rule but that is a good starting position.



    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 18.  RE: EU-MDR Harmonized Standards

    Posted 15-Nov-2021 17:03
    Yes sir Leo, that's how I see it too.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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