Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions

Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension

Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023

Updated information pack for candidate EU reference laboratories published

Call for EU reference laboratories sent to Member States

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746

On 17 June 2022, the European Commission adopted two implementing acts to lay the groundwork for EU reference laboratories for high-risk diagnostics.

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

Notice to Stakeholders EU-Türkiye Customs Union Agreement in the field of medical devices

Update - Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Handover of Experts Panels Secretariat

Updated - Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR