Latest updates

Public health: Stronger rules for placing medical tests on the market

Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Notice to stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices

MDCG 2022-9 - Summary of safety and performance template

Webinar: Healthier Together – EU Non-communicable diseases initiative (22 June 2022, 15.00 - 16.40 CET)

MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC

MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Flash report - Joint Meeting of the Sub-group on Healthier Together – EU NCD Initiative and Sub-group on Cancer (19 May 2022)

Minutes - 5th drafting group meeting on managing AMR across the health system (26 April 2022)