19.09.2022
To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders
Please be informed that, on 14 September 2022, the European Commission published the MDCG 2021-22 Rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert group referred to in Article 48(6) of Regulation (EU) 2017/746.
This document provides information on Class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – sets out the conditions to be applied by the notified body in order to determine whether the expert group must be consulted on the manufacturer’s performance assessment report.
These conditions are: (1) the absence of common specifications for the Class D device in question;
(2) where is the first certification for that specific type of device.
This guideline provides clarification on the meaning of these conditions and the corresponding procedures to be followed by the notified body.
The notification of the European Commission is available online: https://health.ec.europa.eu/system/files/2022-09/mdcg_2021-22_en.pdf.