Anon, let me try and answer your specific questions:
1. Concerning the validity of a product and QMS certificates, which over rules the other one when it comes into MDR? If you have a Product Certificate on a product with XX validity and you have a QMS certificate on YY validity and the QMS certificate expires before the product certificate, is the product no longer compliant with MDD then from YY?
Response: Both certificates have to be valid in order to meet the MDD, so if one expires before the other, the CE mark allowed by those certificates is no longer valid from the expiry date of the first certificate to expire. Discussion with your NB may allow for the expiry dates to be rationalized, however.
2. Or if you have a class I product that is to be registered with your Competent Authority, you must then have a special QMS certificate against MDR then, or does the QMS certificate you had previously for your legacy product apply?
Response: It is assumed you are referring to non-sterile, non-measuring Class I devices. As Richard has stated, there is no such thing as a 'special QMS certificate against MDR'. The MDR requirement for such Class I devices is to have a QMS that complies with MDR Article 10(9) as part of the self-certification process for CE marking such Class I devices under the MDR.
3. As a Class I product you do not have to have a certified QMS, but a manufacturer may have both Class I and II products.
Response: Yes, so Class I device CE marking must follow the applicable conformity assessment process (Article 52(7)), while the Class IIa/IIb devices must follow the conformity assessment processes in Article 52(6) and 52(5) respectively. The MDR includes a certified QMS route option only for the Class IIa/IIb devices. As above, the Class I device QMS requirement is provided in Article 10(9), with no certification requirement.
4. The manufacturer may also have started their audits and TF reviews for MDR but would like to register their Class I products before.
Response: This is perfectly acceptable. Your NB has no input into the CE marking of your Class I non-sterile, non-measuring, non-reusable devices, so this can be undertaken by the manufacturer independently from the NB. 'Registration' may be a problem, however, depending on where you are located. Device registration in Eudamed is not available yet, even on a voluntary basis, and many local competent authorities have yet to advise how local Class I device registrations of MDR compliant Class I devices can be made while Eudamed is unable to accept such registrations.
Hope this helps.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 08-Apr-2021 01:50
From: Richard Vincins
Subject: MDR - validity of a product and QMS certificates, which over rules the other one when it comes into MDR
Good day Anon,
It sounds like you might need a bit more legal advice and not regulatory advice. Both of the situations you presented can be challenging which relates directly to the relationship with your Notified Body. In any case under the EU MDR, the requirement is to have an established, implemented, effective, and maintained quality management system. There is no requirement the quality system must be certified to say EN ISO 13485. However, least burdensome approach is to attain ISO certification supporting the implementing of a quality system, but even ISO 13485 does not address all of the requirements of the EU MDR.
In answering your questions the validity of a QMS certificate should be discussed with your Notified Body because according to content of the regulation like Article 52 and Annex IX - XI, the quality system must be assessed for conformity. Again this does not mean a certificate is necessarily issued, but the quality system needs to be compliant. It gets even more complicated when you have self-declare devices and devices which are reviewed by a Notified Body as they theoretically would not have anything to do with the self-declare devices. There is no such thing as a "special QMS certificate" for EU MDR for self declare products. The responsibility of the Manufacturer for self-declare devices (no Notified Body intervention) is to have a fully compliant quality management system and technical documentation.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 07-Apr-2021 11:09
From: Anonymous Member
Subject: MDR - validity of a product and QMS certificates, which over rules the other one when it comes into MDR
This message was posted by a user wishing to remain anonymous
Concerning the validity of a product and QMS certificates, which over rules the other one when it comes into MDR?
If you have a Product Certificate on a product with XX validity and you have a QMS certificate on YY validity and the QMS certificate expires before the product certificate, is the product no longer compliant with MDD then from YY?
Or if you have a class I product that is to be registered with your Competent Authority, you must then have a special QMS certificate against MDR then, or does the QMS certificate you had previously for your legacy product apply? As a Class I product you do not have to have a certified QMS, but a manufacturer may have both Class I and II products. The manufacturer may also have started their audits and TF reviews for MDR but would like to register their Class I products before.