MDCG 2021-4 Rev. 1: How to apply transitional provisions for certification of class D IVD according to Regulation (EU) 2017/746
26 September 2024
Yesterday, 25 September 2024, the Medical Device Coordination Group (MDCG) published the revised MDCG 2021-4 document on the European Commission’s website. This revision aims to summarise the new key changes to the certification process of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746 for manufacturers and notified bodies, and to clarify the regulatory framework. A particular focus is made on the assessment of certain elements by an expert panel and/or additional testing by an EU Reference Laboratory (EURL).
This guidance document specifies how to apply the IVDR transitional provision in relation to expert panels and the EURLs. As of 1 October 2024, EURLs will be fully operational and designated to carry out specific tasks as defined in Articles 10-16 of Commission Implementing Regulation (EU) 2022/944. If an IVDR has been certified before the EURLs become operational, the certificate will remain valid until its expiry date according to the IVDR. Sample or batch testing, however, is required for all certified devices under the IVDR falling within the scope of a designated EURL (see Q7). In this case, Notified Bodies are obliged to contact the EURL to carry out the activities described in Articles 10, 11 and 13 of the Commission Implementing Regulation (EU) 2022/944.
Until now, there was no guidance for notified bodies based on which they could decide whether a device should be subject to expert panel consultation. Q3 contains a reference to MDCG 2021-22 Rev1 which provides further clarification and guidance on when an expert panel consultation is required. According to Article 48 of the IVDR, it is recommended to consult relevant experts for all Class D devices when this is the first certification of this type of device. The article also provides for a 60-day time limit within which the opinion of the panel must be sent to the notified body (Q4).
If you have further questions regarding Regulation (EU) 2017/746, the MDCG 2021-4 Rev 1 or would like to know whether further steps are required for your product, our SCC experts will be happy to help you.
