Does anyone have any insight on how well EU medical labs are prepared for the in-house requirements of IVDR (Article 5(5)) coming into effect next May? MDCG 2023-1 says that even (for example) making a master-mix of primers, buffers and nucleotides for PCR would be considered manufacturing a medical device and so would require addition to QMS scope, declaration of conformity, manufacturing QA, "post-market" surveillance and application of GSPR, which seems like a big change, but I can't see any discussion about it. Is this because labs are all already on top of it or because labs aren't aware and there's a risk of a big compliance issue from next May?
In-house manufacturing of IVDs under IVDR
- Thread starter DanMann
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