Category: In Vitro Diagnostic Medical Device Regulation IVDR
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
European implementation of Medical Device and IVD Regulations – Implications for Australia
Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC)
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Industry Perspective on the Implementation Status of the MDR/IVDR
European Commission expert panels on medical devices and in vitro diagnostic devices
