M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization…
Posts published in “Europe”
Notification of a Body in the framework of a technical harmonization directive – NB 2862 -Intertek Medical Notified Body AB
Manufacturer incident report 2020 Manufacturer incident report for importing XML file with Adobe Professional 2020 Changelog file 2020
Contacts to allow the check of the validity of the CE certificates
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