In accordance with the conformity assessment procedures (described in Article 48 of IVDR), in addition to quality management system and technical documentation assessments, notified bodies are required to verify product batches of class D IVDs in line with Annexes IX and XI of the IVDR. Therefore, in order to verify the conformity of class D IVDs, manufacturers should forward to notified bodies the reports on tests carried out on each manufactured batch of class D devices IVDR. Moreover, the manufacturer should make available samples of manufactured class D devices or batches of devices to the notified body in accordance with pre-agreed conditions and detailed arrangements.
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The newly published guidance MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies 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 the IVDR.
This guidance also describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs.
It also includes guidance on:
- relevant information to be included within the notified body’s procedures,
- the content of the required pre-agreed conditions and detailed arrangements between the notified body and the manufacturer (IVDR Annex IX Section 4.12 & Annex XI Section 5.1),
- guidance on the frequency of samples of devices or batches of devices to be sent to the EURL (IVDR Annex IX Section 4.12 & Annex XI Section 5.1)
Read more in the MDCG guidance.
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