Hello Hasnaa,
To reiterate Richard's comment, I have had recent experience with consultation submissions to EU Competent Authorities, although based on Rule 14 of Annex VIII rather than Rule 21 although the same GSPR 12.2 applies.
We very closely followed the CDT format for submission and provided ADME/non-clinical data as well as clinical data within the CDT. Fortunately, most of this testing has remained unchanged since our last MDD consultation so we have not had to repeat this and we have also conducted literature reviews to add more recent suporting data also.
As Richard has stated though, the CAs really are very unclear on what they want/expect/need in the submissions and now the powerhouse that was MHRA has been removed from the equation the rest of the CAs are playing catch up on how to handle these submissions for the various device sectors.
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Adam Gregory
Regulatory Affairs Manager
Winsford
United Kingdom
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Original Message:
Sent: 03-Aug-2022 00:12
From: Hasnaa FATEHI
Subject: Substance-based MDs: Rule 21 and GSPR 12.2
Hello,
I am relatively new to the substance-based medical devices world but quite excited for the opportunity to have hands-on experience in this category.
I hit a wall recently though, you (maybe) know what I am talking about. Rule 21, Annex VIII of the EU-MDR in combination with GSPR 12.2 which calls for additional testing per Annex I to Directive 2001/83/EC.
Anyone had experience with the same issue/category of products? If yes, did you run additional testing (e.g. pharmacokinetics)? How long did it take?
Any experience sharing is welcome!
Thank you,
Hasnaa
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Hasnaa FATEHI
Principal Consultant
Vancouver BC
Canada
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