Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
Posts published in April 2020
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
IMDRF Standards Checklist modified in scope of COVID-19
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
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…