Transitional provisions for Class D IVDs: Updates to MDCG 2021-4

In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR).

Compared to the first version, the updated guidance includes, among others:

• Clarifications on scope
• Indication that a question is obsolete (Q1)
• Minor revision or introduction of reference (Q2-Q5)
• Revision of question (Q6)
• Additional question (Q7)

Key points of MDCG 2021-4

MDCG 2021-4 clarifies several aspects related to certifications of class D devices and their transitional provisions, such as:

• Expert panel consultation (Q3 and Q4): notified bodies should consult an expert panel as per IVDR when there are no common specifications and that device is undergoing its first certification for that device type. MDCG 2021-22 clarifies the meaning of “first certification for that type of device”. The expert panel should provide its views within 60 days.
• Designation of EURLs and certification process (Q5 and Q6): notified bodies can accept applications for a class D IVD and issue the certificate if an EURL is not designated for that device. If an EURL for that device is designated at a later time point, the certificate will remain valid until its expiry date, by performing sample of batch testing following the EURLs’ provisions.
• Application date of EURLs’ designation (Q7 – new question): the EURLs’ designation applies from 1 October 2024. Before the certificate issuance, notified bodies should engage with an appropriate EURL as regards preparation for batch testing. The device testing requires signing of contracts, shipping of equipment, shipping of device samples, installation activities, and similar. Test should start as soon as the installation and validation of any equipment are in place – as  of 1 October 2024. For all applications submitted to a notified body from 1 October 2024, notified bodies are obliged to contact appropriate EURLs. For all applications submitted before 1 October 2024 and still without certificate, the notified body should follow the EURL relevant provisions from Annex IX and X when renewing the technical documentation assessment certificates and EU type-examination certificates.

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