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  • 1.  Soft Transition for Class IIa & IIb devices

    This message was posted by a user wishing to remain anonymous
    Posted 04-Mar-2020 12:46
    This message was posted by a user wishing to remain anonymous

    If a company intends to continue to CE mark a Class IIa or IIb device to the MDD, it still must have a PMS plan in place by May.  This plan should include the submission of the 1st PSUR.  For Class IIb, this should be May 2021 at the latest and for Class IIa this should be May 2022 at the latest.

    Is my understanding correct?


  • 2.  RE: Soft Transition for Class IIa & IIb devices

    Posted 05-Mar-2020 02:41
    Dear Anonymous, this is not entirely correct.
    Only for class III devices and implantable devices ​manufacturers shall submit PSURs by means of the electronic system on vigilance and on post-market surveillance to the notified body involved in the conformity assessment. For other devices manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
    Your timeframes are correct, manufacturers of class IIb and class III devices shall update the PSUR at least annually and for class IIa update the PSUR when necessary and at least every two years.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
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    Original Message


  • 3.  RE: Soft Transition for Class IIa & IIb devices

    Posted 05-Mar-2020 08:52
    This has been discussed in other threads, but there are definitely differing opinions on this from this group and also talking to Notified Body auditors.  Because the EU MDR is in force May 2017, working toward compliance should have already started.  Working on compliance does not start 27 May 2020.  Personally, I think you should have a PMSR/PSUR report available during your upgrade audit post May 2020.  Not just a plan to do it in a year.  Because some Notified Bodies I know are taking approach the regulation has been in force already and should be working toward being fully compliant on 26 May 2020.  This means plans and reports should already been in the system.  This is no different than when going toward an ISO 13485 certification audit, they expect to see a full cycle of internal audits, management reviews, and the system being used.  They will not want to walk into your facility doing an EU MDR audit in say August or September, and you turn around and tell them your reports will not be available until the next audit cycle May 2021.  Not a conversation I would want to negotiate through with a NB auditor.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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