Hello Anon,
I understand that you make use of the MDR transitional provisions as documented in article 120(3). I understand the transitional provisions such that the requirements relating to post-market surveillance, market surveillance, vigilance, registrations of Economic Operators and of devices shall apply in place of the corresponding requirements in those Directives.
That means to me that
all the requirements relating to post-market surveillance, market surveillance, vigilance, registrations of Economic Operators and of devices needs to be fulfilled by all parties addressed (Manufacturer, Authorized Representative, Importer, Distributor and Notified Body, to name a few) but this does not mean that all the 'other' QMS-related requirements of the MDR are applicable. E.g. 10(9)a Strategy for regulatory compliance? Having said that, it's not black and white and open to interpretation and expectations of Notified Bodies.
It is beneficial to transition your QMS towards full MDR compliance without undue delay, covered by a Quality plan with planning and resources, because that is what expected by ISO 13485:2016, Clause 5.4.2 Quality Management system planning.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
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Original Message:
Sent: 25-Feb-2021 04:16
From: Richard Vincins
Subject: EU MDR Audit
Hello Anon,
If your QMS audit with scope including European CE Marking is going to be in July 2021, then yes they will perform the assessment against the EU MDR 2017/745. After May 2021, Notified Bodies will not legally be able to audit to the AIMDD as this will no longer be valid as the Date of Compliance of 26 May 2021 will have passed. You should have a discussion with your Notified Body to understand scope of the QMS audit, they should have already advised you it would be to the EU MDR. Keep in mind if your CE Certificate for the AIMDD product is till May 2024, they will still confirm product compliance to the AIMDD and activities under Article 120, i.e. no significant changes. This has been posted in other threads, under the European Union regulations there are basically two assessments: your quality management system (which will be to EU MDR after May 2021) and your product technical documentation (which will be to EU MDR whenever you transition or your current MDD/AIMDD/IVDD CE Certificate expires).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 25-Feb-2021 02:41
From: Kuldeep Tyagi
Subject: EU MDR Audit
Hi,
I am not able to understand when you say Quality audit, do you mean ISO 13485:2016 based QMS Audit? If yes, then it depends on your plan to transition to MDR. In case you have a plan to move to MDR before the audit (which is highly unlikely since your CE certificate expires in 2024), then they would expect your QMS to be compliant with MDR. Else you are not expected to move to MDR.
Regards,
Kuldeep
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Kuldeep Tyagi
Founder and CEO, Saraca
Expert on EMDR, CER, FDA
www.saracasolutions.com
+1- 901-286-1890
Original Message:
Sent: 24-Feb-2021 12:52
From: Anonymous Member
Subject: EU MDR Audit
This message was posted by a user wishing to remain anonymous
All,
Our current CE certificate is issued under the AIMDD and will expire May 2024.
We are anticipating a quality audit this July and would like to know if our current QMS should be updated due to the new EU MDR.
Does the NB will assess us based on the EU MDR or the AIMDD?
Please advise.
Thank you.