Annex I (23.2)(g) does not stand alone. The "as appropriate" depends on how you control the manner of production. If it is by lot number, then the lot number is on label, similarly for serial number, read more
I agree with the longstanding adage that, if there is no lot number or serial number, then a manufacturer may need to recall a wider swath of units than might otherwise be necessary compared to when the read more
Anon, This is a basic Good Manufacturing Practice (GMP) requirement/expectation which has been in place for many years. While regulations may give an option of a serial number or lot number, from a post read more
This message was posted by a user wishing to remain anonymous Is a lot number or serial number on the label always required by EU MDR Annex 23.2(g)? Or does the "as appropriate" instead mean that neither read more
This message was posted by a user wishing to remain anonymous hi, I think many EU IVD manufacturers are currently struggling with the question how to be in compliance when they need venous blood collections read more
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This message was posted by a user wishing to remain anonymous hi, I think many EU IVD manufacturers are currently struggling with the question how to be in compliance when they need venous blood collections for analytical performance studies. The ...
Liebe Community, die ISO/TR Arbeitsgruppe für den Technical Report 20416 (Post-Market Surveillance) hat eine Umfrage gestartet und bittet um Feedback zu dem Dokument, sowie um Verbesserungsvorschläge. Die Umfrage ist noch bis zum 31. Oktober offen. ...
This message was posted by a user wishing to remain anonymous As the title says, can a new (and initial) PCCP be included as part of a Special 510(k)? Reviewing the PCCP guidance, I get the impression that the answer is likely no, but I wanted to ...
Dear Community, Has anyone had experience with being granted a Type D meeting in the form of a teleconference ? In my experience to date, I have only seen WROs granted. I would like to request a meeting that qualifies for Type D, but would prefer ...
Hi all, For drug/biologic INDs supported by a Phase 1-enabling toxicology study(s), we have often taken the option to submit a draft unaudited study report(s) due to tight study start timelines. Has anyone had experience with this strategy now that ...
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