Medical Devices - Sector - Latest updates

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

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

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

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

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

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

MDCG 2022-2 - Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) - January 2022

MDCG 2022-1 - Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

Commission Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745

Commission Implementing Regulation (EU) 2021/2078 laying down rules for the application of Regulation (EU) 2017/745