Hello Anon,
There would probably need to be some clarification because of terminology used. A Certificate of Conformance can be used for a variety of things from supplying raw materials to supplying finished product. A Certificate of Conformance is also not a Declaration of Conformity in the EU - these are two different types of documents and scopes. It is not clear what is meant by 'EU supply' which could be supply of materials into the EU or distribution of finished medical devices in the EU. ISO 13485 and EU ISO 13485 are so-called "voluntary" standards where a company claims compliance or obtains certification to these standards. There is no requirement for mentioning compliance to EU ISO 13485, though companies often do this on their Certificate of Conformance if they are certified to support their quality system activities.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 01-Mar-2024 09:26
From: Dan O'Leary
Subject: EN ISO 13485
Neither Art 17 nor Annex IV requires that the DoC identify the standard used for the QMS. It is not necessary.
However, your QMS should conform to EN ISO 13485:2016/A11:2020, since this is the EU version.
In the end, there will be at least three types of 13485 to contend with:
13485 as written, which most regulations require
13485 as modified by the EU
13485 as modified by FDA in QMSR
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 29-Feb-2024 18:36
From: Anonymous Member
Subject: EN ISO 13485
This message was posted by a user wishing to remain anonymous
Hi,
Recently during our notified body audit , we were challenged by the auditor for not mentioning conformance to EN ISO 13485 on the Certificate of Conformance for EU supply? Is this necessary ?