Regulatory Open Forum

 View Only

  • 1.  ISO 13485 QMS certificate

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jun-2019 08:21
    This message was posted by a user wishing to remain anonymous

    Hi RAPS members,
     Do class I non measuring, non sterile devices need ISO 13485 QMS certificate for EU? 

    Thanks


  • 2.  RE: ISO 13485 QMS certificate

    Posted 26-Jun-2019 19:27

    Under the EU-MDR, the answer is no.

    Art. 52(7) says, "Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III."

    Because these devices don't use Annex IX, X, or XI there is no NB to issue an EU quality management system certificate.

    I'm making the assumption that such a certificate would include the new version of EN ISO 13485 that would have been issued to support the new regulations.



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

    Original Message


  • 3.  RE: ISO 13485 QMS certificate

    Posted 27-Jun-2019 07:52
    There will have to be a new EN version of ISO 13485 created to be Harmonized for the MDR/IVDR as Dan has alluded. There will also have to be a process for Harmonization created for the new regulations as none exists now. Then the standards will have to be submitted and published in the Official Journal along with hundreds of other standards. I hope the process is created soon, although it seems as no one is too concerned about the lack of NBs either.

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

    Original Message


  • 4.  RE: ISO 13485 QMS certificate

    Posted 27-Jun-2019 08:13
    Dan,

    How does the EU expect a class I, non sterile, non measuring device manufacturer to demonstrate compliance with the QMS requirements in Article 10 of the MDR? I would have thought they would expect to see an ISO 13485 certificate. Even if no NB is involved, the manufacturer needs to maintain technical documentation demonstrating compliance with MDR requirements.

    Thanks

    ------------------------------
    Travis Scott
    Rifton NY
    United States
    ------------------------------

    Original Message


  • 5.  RE: ISO 13485 QMS certificate

    Posted 27-Jun-2019 13:50

    My answer is in two parts. First, implement a QMS that satisfies the requirements of Art. 10(9). There are many things required in ISO 13485:2016 that are not in Art. 10(9). Similarly, there are many things in Art. 10(9) that are not in ISO 13485:2016. A review of CEN/TR 17223:2016 will convince you that an ISO 13485:2016 QMS will fall far short of the EU-MDR requirements.

    Second, to whom would you demonstrate your QMS? Nobody will audit you (with one rare exception), so there is nobody to ask for an ISO 13485:2016 certificate. The rare exception is that the competent authority can audit you. However, they should not ask for the certificate because it is not a requirement.

    You must maintain the technical document on your products as required by Annex II and Annex III. There is no NB to audit it. However, your Authorized Representative will review your technical documentation and should point out any discrepancies. (The AR will have a Person Responsible with the required competence to conduct the review.)



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

    Original Message


  • 6.  RE: ISO 13485 QMS certificate

    Posted 27-Jun-2019 15:12
    Dan,

    Since there is not a Harmonization process for the MDR/IVDR it is not possible to get a EN ISO 13485 certificate for the MDR/IVDR.  There will have to be a new EN version of the standard with new "Z Annexes" to identify the route for compliance to the regulations. For instance, with the new ISO 14971:2019 we will have an EN version available following the CEN approval of the submitted standard, but it still will not be Harmonized until a Harmonization Process is in place and staffed to accept submitted standards.  It will be up to the  Notified Bodies and the manufacturers to fill the gap until the Harmonized Standards can be in place.  This is another roadblock to full implementation of the new EU regulations.

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

    Original Message


  • 7.  RE: ISO 13485 QMS certificate

    Posted 27-Jun-2019 21:10

    Ed,

    I'm in total agreement.

    Such Class I devices, however, are a special case. They don't require an NB and they don't require conformity assessment using Annex IX, annex X, or Annex XI.

    A harmonized standard is not a requirement, even if they were to exist. Some NBs require harmonized standard implementation and some do not for the MDD. Leonard Eisner recently commented on the issues this raises with standards in the IEC 60601-1 family. It will be interesting to see their position on May 26, 2020.

    A manufacturer of such a Class I device must complete the CE Mark process by May 26, 2020. The Article 120 transition does not apply. However, such a manufacturer does not have to implement ISO 13485:2016 as the QMS for those devices.



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

    Original Message


Related Content