Other areas MDCG has published revision 1 of the ‘Summary of safety and performance’ format. T1, T2, T3 Read more " April 15, 2024
Other areas The MDCG has published the document ‘Safety reporting in perfomance studies of in vitro diagnostic medical devices under Regulation 8EU) 2017/746’. T1, T2, T3 Read more " April 15, 2024
Other areas The EMA has published revision 2 of the document on anonymization of personal data and assessment of marketing confidential information during the development of PGRs. T3 Read more " April 10, 2024
Other areas A new version of the document ‘Q&A-Pharmacovigilance Legislation’ (Rev.24) has been published. T1, T2, T3 Read more " April 3, 2024
Other areas A new version of the document ‘New organization First User QPPV/RP or Change of EU QPPV/RP’ (13 March 2024) has been published (T1, T2, T3). Read more " March 13, 2024
