REACH Authorisation Decisions List
Posts published in “In Vitro Diagnostic Medical Device Regulation IVDR”
Second NB under the IVDR notified – BSI UK notified under the IVDR
Ongoing Guidance development within MDCG Subgroups
So it seems EUDAMED will be delayed by 2 years. Let’s see if an official announcement is made soon…
Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
Flyer – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Regulation (EU) 2017/746 on in vitro diagnostic medical devices – NB 0124 DEKRA Certification GmbH Germany
State-of-play of joint assessments of Notified Bodies in the medical device sector
EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 Manufacturer incident report Helptext 2020 Manufacturer incident report…