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Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form
Commission Guidelines on Union-wide derogations for medical devices
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context
Changelog file 2020
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
Privacy statement - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies
MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
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