Medical device CE marking

3 New MDCG documents published

2022-05

On May 20, 2022, the MDCG published 3 new documents:

  • MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
    This document presents questions and answers on the Unique Device Identification system (UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The questions covered by the document aim to provide further detail to operators on the application and practical implementation of the UDI requirements.
  • 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
    Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3), in terms of scope and timing. Following the approach set out in the report of the MDCG ad hoc task-force on transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) published as MDCG 2021-25 , the present document provides guidance as regards the applicability of IVDR requirements to ‘legacy devices’ and ‘old’ devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to ‘legacy devices’.
  • MDCG 2022-9 – Summary of safety and performance Template
    Section 1 – SSP Template for devices not intended for self-testing
    Section 2 – SSP Template for self-testing devices

Source: European Commission