Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
Posts published in “Medical Devices Directive – MDD”
UL International (UK) Ltd. (NB 0843) – Medical Device Notified Body Ceasing Operation In the UK
Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019)
New version, Version 1.21 (01-2019) – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES
Manufacturers with CE Marking shall update their procedures and forms. Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários. Manufacturer Incident Report (MIR) for Serious…
The EU Commission published some new templates for Field Safety Notices related to the current medical device directives and MEDDEV 2.12/1 rev.8. template links are below (they…