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…
Posts published in “In Vitro Diagnostic Medical Device Regulation IVDR”
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
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…
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…
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