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  • 1.  EU MDR Audit scope

    Posted 21-Apr-2019 20:52
    ​​Hi RAPS members,

    During preparation of EU MDR, I'm a bit confused scope of EU MDR works to receive audit prior to enforcement date, May. 26, 2020.
    I guess technical files of all devices and SOPs of new requirements such as PSUR should be ready.

    How about agreement with economic operators, incluing Authorised representative, importer and distributor?
    In EU MDR, they have expanded or created new obligations which should be addressed through new/amended agreement/contract.
    Should it also be readied for audit?

    Thank you for your advice in advance.

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    Jeongpyo Hong
    Sr. Professional, Regulatory Affairs
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  • 2.  RE: EU MDR Audit scope

    Posted 22-Apr-2019 05:24
    Simple answer Jeongpyo: Yes.  If you are going through a Notified Body audit (once designated) prior to May 2020 for EU MDR, then expectations is your full quality system and technical documentation will be compliant.  If you are extending some of your MDD CE Certificates beyond May 20202, then any audit to EU scope after May 2020 will assess the quality system against the requirements (and expectations) of the EU MDR.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: EU MDR Audit scope

    Posted 22-Apr-2019 07:46

    The easy way to think about this that everything you need for conformance to the EU-MDR is in place on the day you submit your Annex IX application. You must include a lot of the documentation with the application. For example, you will need submit your QMS documentation of clinical evaluation system and for each device a clinical evaluation plan and a clinical evaluation report.

    This means (at least) implementing Article 10, Article 15, establishing contracts with other economic operators, and preparing the Annex II and Annex III technical documentation.

    Consider the optimistic case. Your MDR Notified Body has a queue of six months. This means that from the time they receive your Annex IX application, it will take them 6 months to schedule the audit, conduct, the audit, and issue the certificates. That will allow you to complete the Declarations of Conformity and put the EU-MDR CE Mark on your products. In this case you need to have fully implemented the EU-MDR and submitted your application by December 26, 2019.

    Consider the likely case. You will use the Article 120 soft transition to keep your devices on the market. You will follow the methods established by your MDD (not MDR) Notified Body. The means using the MDD technical documentation and a hybrid QMS that includes MDR post-market surveillance, market surveillance, and vigilance. If the MDD NB has a six month queue, the you will have to submit all the documentation by December 26, 2019. Many MDD NBs have a longer queue. They may have a two-step process. The first is an application to enter the queue and the second is the application for the hybrid system audit. I know of one NB that wanted the first application by March 31, 2019 and I've heard that others wanted it sooner.

    Consider the pessimistic case. Neither your company nor the NB (either MMD or MDR) can complete all the work by May 26, 2020. In this case, you will not be able to sell products in the EU.



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


  • 4.  RE: EU MDR Audit scope

    Posted 22-Apr-2019 21:57
    Thank you for your kind advice, Richard and Dan.​

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    Jeongpyo Hong
    Sr. Professional, Regulatory Affairs
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    Original Message


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