Regulatory Open Forum

Dear all

We are manufacturing products of class IIa, aiming for the Conformity Assessment Procedure of MDR, annex XI. We would appreciate very much if you comment both our analysis of the MDR requirements as well as our envisaged approach.

1. Article 52(6) refers for products of class IIa to section 10 in Annex XI.
2. Section 10.1 asks manufacturer to declare that products meet the requirements of Annexes II and III.
3. Section 10.2 refers for the QMS to section 6.3 of Annex IX and 6.3 itself to section 2.3 of Annex IX.
4. Section 2.3 asks NB to audit the QMS based on the requirements of section 2.2 and assume conformity if harmonised standards are satisfied

Last point is interpreted that NB can opt for a desktop audit on documentation confirming fulfilment of the requirements of section 2.2 if there is also an audit report of ISO 13485 available. This option is supported by paragraph 2 of article 52(6) which requires just a conformity assessment and of paragraph 2 of section 2.2 which mentions documentation to be submitted for the assessment of the quality management system. In addition annex XI does not refer to section 2.1, which lays down the application to the NB for a QMS assessment.

Our approach would be to pass an ISO 13485 audit. The auditors do not need necessarily to be approved as MDR auditors. We can receive a MDR certificate just by filing in the detailed audit report, detailed documents in accordance with the requirements of section 2.2 and the technical documentation of a product. As long as our MDD certificate is still valid, the technical documentation has just to fulfil MDD requirements.

Can you confirm this approach? Could this approach reduce the MDR certification work of NB drastically with regard to I* and IIa manufactures?

Thank you very much!

Jürg

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Jürg Allemann
QA/RA Manager
Dübendorf
Switzerland
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Jürg,

Unfortunately because there has been no Notified Body audit to the new EU MDR 2017/745, it is not quite clear on the exact approach Notified Bodies will be taking.  The least burdensome approach for quality management system is to achieve EN ISO 13485 certification through either a Registrar and/or Notified Body - it would be best to get QMS certification from the same NB doing QMS and technical documentation review.  The legal manufacturer needs to comply, complete, and have available all technical documentation under Annex II and III.  Regarding desktop audits, remote audits of technical documentation, before or after QMS certification, you should have these discussions with your NB.  Again, not sure anyone can answer that question at the moment since no NB audits to EU MDR have been performed.  If you are planning to renew your MDD Certificate this does not have anything to do with the EU MDR regulation.  You should discuss with your NB on renewal of the MDD and when you would upgrade/update to a MDR certificate.

'Our approach would be to pass an ISO 13485 audit. The auditors do not need necessarily to be approved as MDR auditors. We can receive a MDR certificate just by filing in the detailed audit report, detailed documents in accordance with the requirements of section 2.2 and the technical documentation of a product.'  This statement you made there, not sure a viable approach to upgrading to MDR certification.  You should definitely discuss this with your NB.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Jul-2019 03:04
From: Jürg Allemann
Subject: Conformity Assessment Procedure under MDR, annex XI

Dear all

We are manufacturing products of class IIa, aiming for the Conformity Assessment Procedure of MDR, annex XI. We would appreciate very much if you comment both our analysis of the MDR requirements as well as our envisaged approach.

1. Article 52(6) refers for products of class IIa to section 10 in Annex XI.
2. Section 10.1 asks manufacturer to declare that products meet the requirements of Annexes II and III.
3. Section 10.2 refers for the QMS to section 6.3 of Annex IX and 6.3 itself to section 2.3 of Annex IX.
4. Section 2.3 asks NB to audit the QMS based on the requirements of section 2.2 and assume conformity if harmonised standards are satisfied

Last point is interpreted that NB can opt for a desktop audit on documentation confirming fulfilment of the requirements of section 2.2 if there is also an audit report of ISO 13485 available. This option is supported by paragraph 2 of article 52(6) which requires just a conformity assessment and of paragraph 2 of section 2.2 which mentions documentation to be submitted for the assessment of the quality management system. In addition annex XI does not refer to section 2.1, which lays down the application to the NB for a QMS assessment.

Our approach would be to pass an ISO 13485 audit. The auditors do not need necessarily to be approved as MDR auditors. We can receive a MDR certificate just by filing in the detailed audit report, detailed documents in accordance with the requirements of section 2.2 and the technical documentation of a product. As long as our MDD certificate is still valid, the technical documentation has just to fulfil MDD requirements.

Can you confirm this approach? Could this approach reduce the MDR certification work of NB drastically with regard to I* and IIa manufactures?

Thank you very much!

Jürg

------------------------------
Jürg Allemann
QA/RA Manager
Dübendorf
Switzerland
------------------------------