MDCG 2022-3 Rev.1 released
MDCG 2022-3 Rev.1 released
Regulatory Affairs In Vitro Diagnostics
Tuesday, 24 December 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On December 18, 2024, the Medical Device Coordination Group (MDCG) released a revision of the guidance on verification of manufactured class D IVDs by notified bodies.
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MDCG 2022-3 Rev.1 released | QbD Group Regulatory Update
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Notified bodies are required to verify product batches of class D IVDs. Therefore, manufacturers should forward to notified bodies the reports on tests carried out on each manufactured batch of class D devices, and they should also make samples of such devices available to the notified body.
If designated by the European Commission, one of the EU reference laboratories (EURLs) should carry out batch testing on class D IVDs and, in turn, inform the notified body about its findings. This MDCG 2022-3 guidance document aims to provide guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of Regulation (EU) 2017/746 (IVDR).
MDCG 2022-3 Rev.1: Verification of manufactured class D IVDs by notified bodies
Some key takeaways from MDCG 2022-3 Rev.1:
This revision contains several subtle updates and clarifications, such as:
- A clarification that not all Class D devices are subject to batch testing, for example IVDR batch testing requirements do not apply to Class D medical software.
- The verification test plan no longer needs to contain decision making criteria for success or failure of the batch. However, such criteria must be included in the agreement between the notified body and the EURL.
- It is also clarified that testing, results and conclusions need to take place within 30 calendar days rather than weekdays.
- A clarification is added that the manufacturer may have direct agreements with an EURL for logistic aspects, under the oversight of the notified body.
- A previous note, specifying that calibrators and controls intended to be used specifically with a device/reagent should be considered as the same level of risk as the corresponding device/reagent, has been removed.
- In the determination of the initial number of samples to be sent to the EURLs, the previously included sentence “For first-line assays and devices intended for diagnosis every batch has to be tested” has been revised to “For first-line assays falling under the first indent of rule 1 section 2 Annex VIII every batch has to be tested”.
- In the determination of the testing frequency for each group of class D IVDs, a note has been added to make specific provisions for calibrators and controls placed on the market separately from the corresponding device(s)/reagent(s).
What does this mean to you?
MDCG 2022-3 Rev.1 is important for all manufacturers of class D IVDs. The guidance helps to better understand the process to be followed for batch testing, and the interaction between the manufacturer, their notified body and the EURLs. Understanding the current revision is important to take MDCG’s current interpretation of these processes into account.
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