Hi Meenakshi,
The general practice is to up-rev the CER- rev A to B to C and so on whatever the update, because that's better document control and if you use a doc management/ control software, that's how its most probably going to work. And with an important document like CER, you want to keep a detailed, self-explanatory Revision history and add new revisions whatever be the changes to the document - full literature update, update to complaints, updates from risk analysis activities from field actions, updates because of design changes or just a regulatory submission.
Your revision history can capture sections that were changed/not changed in the rev history. Of course, I don't see it being a hard and fast rule. Depending upon the extent of changes, you could choose to add/not add a revision number. I think creating new versions anytime there is an update is a cleaner process.
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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
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Original Message:
Sent: 10-Jul-2018 10:21
From: Meenakshi Verma
Subject: Clinical Evaluation Report
Hi,
Can anyone guide what is the best practice to pen down the update to a EU Clinical Evaluation Report? Is there any link whereby this is summarized?
Will it be just a new version? Like Version A and Version B?
Or Will it be an amendment document which will be an appendix to the initial version of the CER summarizing the sections which have changes and for the unchanged sections stating no changes made?
Any guidance is highly appreciated.
Best regards,
Meenakshi
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Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
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