This message was posted by a user wishing to remain anonymous
That was a lot of detailed information VERY USEFUL regarding the person responsible for signing the DoC. Thank you very much.
Another question would the notified body be informed via email of a change such as a discontinued product being removed from the DoC? Signature change as person no longer with the company? We do have an audit coming up, would a gap analysis be done from the last DoC to the current one as no notification/information was provided to the notified body.
Richard you mentioned in the future the DoC will get uploaded within EUDAMED, any idea when that will be?
Original Message:
Sent: 24-May-2023 11:07
From: Richard Vincins
Subject: PRRC - Declaration of Conformity
Hello Anon,
I have a slightly different view on how a Person Responsible for Regulatory Compliance (PRRC) is related to the Declaration of Conformity (DofC). Traditionally in the past, the DofC was usually signed by the most responsible in the quality system management, typically would have been the head of Quality or head of Regulatory (or smaller organisations would be both). There is no PRRC in EU MDD, so it was usually as just stated. I remember one time years ago (in the EU MDD world) a company had their Operations Manager sign the DofC when they had a Director of QA/RA (both reported to the CEO, but the Dir. QA/RA was "hands off" type of person) - the Notified Body questioned that, there was long discussions, and in the end they changed to the Dir. QA/RA.
Now concerning signing and dating the DofC, the whole point of having the PRRC signing because the key word is in the name ... 'responsible.' If you read Article 15, point 3 and the sub-points, it is pretty clear to me, this is the responsible person for quality and regulatory in particular for the product: 'the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.' As with any quality system or company, there are nuances and specifics which are not the same in every situation. But in general, why would a company not have the PRRC sign a DofC because according to their role and the description in the regulation, they are responsible. Now, can the President/CEO be the person signing? Sure. Can the head of quality/regulatory sign who are not the PRRC? Sure. Though why would the head of quality/regulatory not be the PRRC? Again, there are circumstances in companies, there can be more than one PRRC, it may be done externally, etc., but again in general it should be the most responsible person signing the DofC, thus the most responsible can be understood as the PRRC. If the PRRC is external to the company, then this is something the company needs to consider from a liability perspective and who at the company would take this responsibility for signing the DofC. Ultimately, if you have NB interaction (meaning Class IIa and above with sterile/measuring/reusable included) confirm with them who should be signing the DofC, because they will have their own expectation and interpretation from the regulation.
A change to the Declaration of Conformity is fairly straight-forward for me if there is a change made. Notified Body (NB) should be informed. Most Notified Bodies have their own criteria, which includes any change to the DofC, even just making updates to an Appendix or product listing (this could still be viewed as significant). At a minimum, if a DofC changes, your Notified Body should be sent the updated version with brief explanation of why it changed. Generally, if structured correctly, a DofC should not change that much. In the future this will not be so much of an issue, because within EUDAMED the DofC will get uploaded, so the most current version of a device or device family DofC would be located in EUDAMED which the NB or other entities can access.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 24-May-2023 03:15
From: Ronald Boumans
Subject: PRRC - Declaration of Conformity
Why would the PRRC sign the DoC? This may sound strange, but I don't consider signing regulatory documents part of the role of the PRRC. The PRRC is there to observe, form an opinion, and advice based on that opinion. That does not sound like much, but it is quite a task.
If a company insist the PRRC signs the DoC, and the PRRC agrees, that signature is just the same as any other signature. It should be valid and justified. If the person who signed changes or leaves the company, that does not change anything to the DoC. That signature was valid at the moment of signing and it remains valid if that person is no longer in the same position.
If a DoC is changed significant, it should be signed again. This can be done by anybody formally representing the company and under the rules of the certification applicable at the moment of signing. However, non-significant changes can be added by an addendum. For example, a change of address of the legal manufacturer that does not impact the conformity of the device or a change in authorized representative are not considered significant.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 23-May-2023 01:11
From: Anonymous Member
Subject: PRRC - Declaration of Conformity
This message was posted by a user wishing to remain anonymous
Please could anyone advise on what the responsibilities are for the PRRC responsible for the Declaration of Conformity, presently under MDD 93/42/EEC and moving forward with EU MDR.
If changes have been made to the DoC since last presented to the notified body i.e. discontinued product or addition of product, change of PRRC signing the DoC how do we determine whether these kind of changes need to be reported to the notified body.
Any advise would be greatly appreciated.