MDCG Manual on borderline & classification medical devices 2017/745 and IVD 2017/746, 09/22 Beatrice Burtsov2023-06-09T07:23:20+00:00November 8th, 2022|
EU Clinical Trials Regulation EU 536/2014, Questions & Answers, Version 6.2, 09/22 Beatrice Burtsov2023-06-09T07:21:35+00:00October 5th, 2022|
EU Guidance Inspection of Tissue & Cell procurement and Tissue establishments, 04/15 Beatrice Burtsov2022-04-05T13:27:16+00:00April 5th, 2022|
EMA Post-authorisation procedural advice for users of the centralised procedure, 12/21 Beatrice Burtsov2023-06-09T07:20:21+00:00January 26th, 2022|
EMA Reflection paper on GMP and Marketing Authorisation Holders, 07/21 Anna Sandberg2023-06-09T07:22:07+00:00September 29th, 2021|
EMA Guideline on Quality documentation for medicinal products used with a medical device, 07/21 Anna Sandberg2023-06-09T07:19:50+00:00September 28th, 2021|