Category: In Vitro Diagnostic Medical Device Regulation IVDR
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 for importing XML file with Adobe Professional 2020 Changelog file 2020
Application form – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Procedural guidance on declaration of interests – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Declarations on confidentiality and commitment – Call […]
Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices
EU – State-of-play of joint assessments of Notified Bodies in the medical device sector – June 2019
Update – MDR and IVDR implementing measures rolling plan
Unique Device Identification (UDI) System – FAQs
EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay
