Good day Anon,
This might be some standard wording your Notified Body uses in their report, but indeed is quite a strange statement. It is always confusing when statements are written in double-negative phrases.
You are absolutely correct, there are a few documents which will be publicly available once EUDAMED is fully functional such as the SSCP and vigilance information. There are other documents which will be uploaded to electronic systems which at this time seems only viewable by Notified Bodies and/or Competent Authorities. Indeed the GSPR and Clinical Evaluation would not be posted publicly as these would contain significant proprietary and confidential information. They way I read that statement is they are just saying this would not be available as there is no Class III, but it would be interesting for you to post the entire information for the communities information. Hopefully it is that, and hopefully not something that is blatantly wrong.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Apr-2021 15:36
From: Anonymous Member
Subject: GSPRs and clinical evaluations: publicly available?
This message was posted by a user wishing to remain anonymous
Hello,
I took note of this line from our MDR assessment report: "I confirmed the requirements for GSPR/Clinical Evaluations to be publicly available do not apply, as there are no Class III devices per device schedule."
We do not have an EU Class III device, but I would like to clarify this for my own understanding. Per my reading of MDR, SSCPs are expected to be publicly available, but I have not seen any mention of the entire GSPRs and clinical evaluations needing to be publicly available. Has anyone come across this expectation before?
Thank you.