Update – MDR and IVDR implementing measures rolling plan
Posts tagged as “IVDR”
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
Factsheet for healthcare professionals and health institutions
Update from the EU Council – Public session (health) – Friday, 14 June 2019 10:25 CET
UK NB Will Not Apply for EU MDR/IVDR