MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
Posts published in “Medical Device Regulation MDR”
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…
MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the…
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application…
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions