Medical Devices - Sector - Latest updates

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

MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements

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)

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

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

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

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 2022-9 - Summary of safety and performance template

MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on 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)

Update - MDCG 2019-9 - Rev.1 - Summary of safety and clinical performance

Handover of Experts Panels Secretariat

Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

Update - MDCG 2021-21 Rev.1 - Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

MDCG 2022-3 - Verification of manufactured class D IVDs by notified bodies

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