Contacts to allow the check of the validity of the CE certificates
Medical Device Expert News
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
Ongoing Guidance development within MDCG Subgroups
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
Privacy statement – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Notification of a Body in the framework of a technical harmonization directive – NB 0483 – MDC MEDICAL DEVICE CERTIFICATION GMBH
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. 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…