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…
Posts tagged as “MDR”
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
Industry Perspective on the Implementation Status of the MDR/IVDR
European Commission expert panels on medical devices and in vitro diagnostic devices
Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’
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
The next meeting of the MDCG is schedule for 20 June 2019. Some guidance are up for endorsement: Vigilance: Manufacturer Periodic Safety Report (MPSR) form…