Class D IVD Certification: Updated Guidance

The MDCG 2021-4 rev.1 document, updated in September 2024, offers essential guidance on Class D IVD Certification, specifically focusing on the transitional provisions under Regulation (EU) 2017/746. This updated guidance details the steps and requirements manufacturers must follow to secure certification during the transition period.

For more detailed information, read the full guidance here. 

Key Changes:

Introduction: The introduction now includes a link to the Commission Implementing Regulation (EU) 2023/2713. This update is significant because the first EURL (EU reference laboratory) designations become applicable for EURL tasks starting from October 1, 2024. 

Q1: The question has been removed as the date of May 26, 2022, for Notified Bodies to accept applications for the certification of Class D IVDs has passed. 

Q2: The option for manufacturers to provide the performance evaluation report within five days of the expert panel becoming operational has been removed. 

Q3: The updated guidance now includes MDCG 2021-22, which provides clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies in the context of the expert panel consultation referred to in Article 48(6) of Regulation (EU) 2017/746. 

Q4: Minor wording change. 

Q5: Wording change – the term “transition period” has been removed. 

Q6: The updated guidance adds provisions on consulting the EURL in case of changes. This includes the second paragraph of Section 4.11 of Annex IX or Section 5.4 of Annex X, if the initial performance verification by an EURL is carried out. 

Q7: New question added: “What does the date of application of the designation of EURLs (October 1, 2024) mean in practical terms for EURL tasks, particularly for sample or batch testing according to Article 100(2)(b) IVDR and performance verification according to Article 100(2)(a)?” 

• • From October 1, 2024, designated EURLs must undertake the responsibilities outlined in Articles 10-16 of Commission Implementing Regulation (EU) 2022/944. For batch testing, Notified Bodies that have issued IVDR certificates for Class D devices must contact a relevant EURL to perform activities detailed in Articles 10, 11, and 13 of the same regulation. 

Important Considerations for Manufacturers and Notified Bodies:

Batch Testing Preparations

Notified Bodies are expected to coordinate with EURLs before issuing certificates for any Class D devices they assess under the IVDR that fall within the scope of the designated EURLs. Preparations include contract finalization, equipment and sample shipment, and installation tasks. Since EURLs must support and conduct these tasks from October 1, 2024, actual testing may not commence immediately but will occur as individual circumstances permit following proper setup and validation of necessary equipment. 

Performance Verification

For Class D devices submitted to a Notified Body from October 1, 2024, within the scope of designated EURLs, Notified Bodies must liaise with the appropriate EURLs as part of the conformity assessment process, per Articles 10-12 of Commission Implementing Regulation 2022/944. For applications submitted before October 1, 2024, but without a certificate issued by that date, Notified Bodies should adhere to the EURL-related requirements during the renewal process for EU technical documentation assessment certificates and EU type-examination certificates. 

Stay updated with the latest regulatory news to ensure compliance and smooth transitions during this period. If you need support, please contact us so we can help.

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