This message was posted by a user wishing to remain anonymous
Leonard, Roger, and Richard - Thank you for your conformations. We already have a 13485 certificate, and we held our recertification audit recently, so we will have a newly issued certificate for 13485. We also had a separate (initial) MDR audit, for which I believe we should get a separate MDR QMS certificate.
Could it be that BSI might put 13485 and MDR on the same certificate? I would think not, considering the recertifications are on different schedules (3 and 5 years), so that would not make sense.
Richard - I too am very curious on why BSI is saying this. This was stated by someone who was speaking to us on behalf of the Scheme Manager while he was on vacation. We are working on getting clarification, but it's taking a few days due to overlapping vacation schedules.
Original Message:
Sent: 03-Apr-2021 05:34
From: Richard Vincins
Subject: MDR QMS Certificate?
Good day Anon,
There are basically two certificates issued under the EU MDR (and also the previous EU MDD):
- QMS certificate to EU MDR (things like Article 10, Annex IX - XI - and also most companies utilise EN ISO 13485 as least burdensome approach)
- EC Certificate or CE Certificate issued by device or device family - this depend on how many product families or groupings there may be
I would be curious why your Notified Body is saying there is not a QMS certificate - is this from your Scheme Manager, Sales person, the auditor? You definitely want to get clarification from your Notified Body on this point because they are the ones issuing you certificates for EU MDR.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 03-Apr-2021 03:54
From: Roger Gray
Subject: MDR QMS Certificate?
MDR Annex XII lists the different types of certificates issued by Notified Bodies, viz:
- EU technical documentation assessment certificates
- EU type-examination certificates
- EU product verification certificates
- EU quality management system certificates
- EU quality assurance certificates
Annexes IX, X and XI explain which certificate(s) are issued for which conformity assessment paths followed.
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.com
www.donawa.com
Original Message:
Sent: 02-Apr-2021 16:06
From: Leonard Eisner
Subject: MDR QMS Certificate?
Yes, all Notified Bodies will have to issue an MDR QMS certificate based on the appropriate path and classification used.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
Original Message:
Sent: 02-Apr-2021 14:46
From: Anonymous Member
Subject: MDR QMS Certificate?
This message was posted by a user wishing to remain anonymous
Hi everyone,
I know there is a product-specific EC certificate issued after the Technical Documentation review.
Is there an MDR QMS certificate (similar to an ISO 13485 certificate) issued after an MDR QMS audit? I'm convinced there is because I've seen mentions of it in various places but our Notified Body (BSI) said there isn't. I've even seen an example of an MDR QMS certificate issued by TUV SUD on this forum. Could Notified Bodies be handling this differently? Doesn't seem like the sort of thing NBs should be diverging on.
We are working on getting clarity from BSI but input from your experiences are welcome!
Thanks.