Category: Medical Devices Directive – MDD
Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
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 Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) New Manufacturer Incident Report helptext.
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 can also be found at: https://ec.europa.eu/growth/sectors/medical-devices/guidance_en). A Comissão da UE publicou alguns novos modelos para Avisos de Segurança de Campo relacionados às diretivas atuais de dispositivos médicos e ao MEDDEV 2.12 […]