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active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022 and it repeals Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic [...] quality documentation for medicinal products when used with a medical device ”, valid since 01.01.2022) and the EMA Q&A document in the current revision (EMA/37991/2019, “ Questions & Answers for applicants
2017/745 07/03/2022 Document: Guideline for the classification of change requests | 222 KB Guidance for classification and reporting of amendments during the clinical investigation 07/03/2022 Form: Changes [...] Regulation (EU) 2017/745 25/02/2022 Form: Changes with relevance for monitoring | 91 KB Changes to the investigation with significance for the regulatory oversight 25/02/2022 Form: Security measures, suspension [...] (EU) 2017/745 25/02/2022 Form: Termination notification | 44 KB Notification of completion of a clinical investigation according to Article 77 of Regulation (EU) 2017/745 25/02/2022 SAE Reporting Form |