MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
Medical Device Expert News
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…
When participating in a discussion about ISO 14971 with Monir El Azzouzi, I mentioned suggestions about what to study to understand medical device risk management,…
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
MDCG 2019-3 Interpretation of Article 54(2)b rev 1
Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
Critical items for clinical management of COVID-19
Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
Conformity assessment procedures for protective equipment