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Harmonized standards under the MDR

  • 1.  Harmonized standards under the MDR

    Posted 10-Sep-2021 10:11
    Hello,

    is there already more known about the harmonized standards that can be used under the MDR?
    Those are still not listed on the website of the ec
    Still only referring to the MDD
    Or can be just refer to the latest version of the standards (non harmonized) ?

    Greetings,

    ------------------------------
    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
    ------------------------------


  • 2.  RE: Harmonized standards under the MDR

    Posted 10-Sep-2021 10:23

    Some standards are harmonized under the MDR. See https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en


    In meeting the MDR or IVDR Annex I requirements, there is no regulatory requirement to use a harmonized standard. However, I tell my clients that the best order to select standards is:
    EU harmonized to the MDR or to the IVDR
    EN not harmonized
    ISO or IEC not EN

    The EN standards may be behind the ISO or IEC. For example, the ISO standard on symbols is not yet a published EN standard so I recommend using the ISO version.

    Standards harmonized under the directives may not be considered as harmonized under the regulations.



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

    Original Message


  • 3.  RE: Harmonized standards under the MDR

    Posted 10-Sep-2021 14:37
    Hi Franky

    The main page still says MDD, which is a little confusing.
    https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

    But if you click the link, it goes to the page Dan mentioned​, where you can find the standards published for both MDD and MDR.

    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------

    Original Message


  • 4.  RE: Harmonized standards under the MDR

    Posted 11-Sep-2021 15:17
    I would go a couple of steps further with Dan's list of best Harmonized standards &/or standards are (italics are added by me):
    EU harmonized standards to the MDR or to the IVDR
    EN not harmonized
    EU Country Specific National Standards that are not EN based (not part of CEN or CENELEC or ETSI)
    ISO or IEC or ASTM not EN
    Non EU Country National Standards (i.e. AAMI, UL, CSA, NFPA, ANSI, etc.)

    A non standard concept -- the manufacturer's own internal specifications to test against if there is no standard and the manufacturer is the expert in the field.  Would have a high bar to prove to the notified body in this case.

    I would like to clarify Dan's following comment on EN ISO 15223-1 has been approved but not yet published by the European Standards Organizations (ESOs). "The EN standards may be behind the ISO or IEC. For example, the ISO standard on symbols is not yet a published EN standard so I recommend using the ISO version."


    ------------------------------
    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


  • 5.  RE: Harmonized standards under the MDR

    Posted 11-Sep-2021 06:41
    Yesterday BSI released BS EN ISO 13485:2016+A11:2021 which will be the Harmonized version of the standard when it is published in the Official Journal. CEN has completed their portion of Harmonization and it is up to the EC to acknowledge that standard. The last word on the street is that the publication in the Official Journal may only occur a couple of times a year. 
    Manufacturers can get a jump on updating their Quality System for MDR or IVDR with the use of this latest version. 
    The requirements in the standard itself (Clauses 1-8) did not change, the new document contains Annexes ZA and ZB which discusses the relationship of the standard to the regulatory requirements in the EU. 
    Other European standards providers will also be publishing their copies of this standard, but will be identical as this is a CEN standard. So you should be able to get a copy from your EU standards provider. 


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

    Original Message


  • 6.  RE: Harmonized standards under the MDR

    Posted 17-Sep-2021 12:37
    I just looked at BS EN ISO 13485:2016+A11:2021 and noticed that it includes a National Annex NZ addressing UK MDR 2002, but does not address the EU MDR nor IVDR in Z Annexes; does anyone know if this will be in a different version?

    ------------------------------
    Christopher Erwin
    Scottsdale AZ
    United States
    ------------------------------

    Original Message


  • 7.  RE: Harmonized standards under the MDR

    Posted 18-Sep-2021 07:34
    Hey

    There is- it is just in the beginning of the document. Took me some time to find it also.

    Great day :)

    ------------------------------
    Ella Sheiman
    Haifa
    Israel
    ------------------------------

    Original Message


  • 8.  RE: Harmonized standards under the MDR

    Posted 18-Sep-2021 08:33

    The following description is from BSI standards describing contents of the edition I referred to and indicates annexes for MDR and IVDR are in this edition  

    https://shop.bsigroup.com/products/medical-devices-quality-management-systems-requirements-for-regulatory-purposes-3



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

    Original Message


  • 9.  RE: Harmonized standards under the MDR

    Posted 18-Sep-2021 13:56
    Ah, it seems BSI was a bit misleading as they added a NZ annex for the national UK MDR 2002 rather than EU MDR.

    ---------------------------------
    Christopher Erwin


    Scottsdale AZ
    United States
    ---------------------------------



    Original Message


  • 10.  RE: Harmonized standards under the MDR

    Posted 18-Sep-2021 16:02
    From the cited announcement:

    What's new about BS EN ISO 13485:2016+A11:2021?

    This is an amendment to BS EN ISO 13485:2016 which adds annexes mapping the requirements of the European MDR and IVDR against the requirements for quality management systems within each of the regulations. Each regulation has its own annex. Each annex contains three tables. These three tables map out the relationship of the standard with requirements in the regulation



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

    Original Message


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