MDCG offers clarification on ‘first certification’ trigger for IVDR expert panel review

The European Commission’s Medical Devices Coordination Group (MDCG) on Wednesday released a document explaining what constitutes the “first certification” of a high-risk in vitro diagnostic device in the context of determining whether an expert panel review is required under the In Vitro Diagnostic Regulation (IVDR).

Under Article 48(6) of IVDR, notified bodies are required to consult with the expert panel on the performance evaluation report supplied by the manufacturer of an IVD when common specifications for a class D device do not exist and it is the “first certification for that type of device.”

Recital 53 of IVDR specifies that notified bodies should consult the expert panel when the first certification for a specific type of device comes up “and there is no similar device on the market having the same intended purpose and based on similar technology.”

“Therefore, ‘first certification for that type of device’ in Article 48(6) of the IVDR should be understood as the first certification under either Directive 98/79/EC or under Regulation (EU) 2017/746 by any notified body in relation to a product with a specific … intended purpose [or] analysis technology and process used,” MDCG said.

The group also offers a list of factors related to the intended purpose that should be considered, including what is detected or measured; the function of the device; the disease, condition or risk factor it is intended to detect, define or differentiate; and whether the test is automatic, qualitative, semi-quantitative or quantitative. Other considerations include what type of specimen(s) are required, who makes up the testing population and who are the intended users of the test.

“Once a device with a specific set of elements … has been certified either under Directive 98/79/EC or under Regulation (EU) 2017/746, any other device to be certified for the first time under Regulation (EU) 2017/746 with a similar set of elements will be considered the same “type of device” irrespective of the manufacturer and therefore will not need to be subject to a consultation with the expert panel,” MDCG said.

It is up to notified bodies to determine whether a certification is the first for a type of device. MDCG writes that notified bodies should rely on their knowledge and expertise, information provided by the manufacturer, and “the information on type of device for the already completed and ongoing consultations of the expert panel.”

“If the notified body comes to the conclusion that no device of that type has been certified yet (either under Directive 98/79/EC or under Regulation (EU) 2017/746), and if no common specifications are available for that device, the notified body has to consult the expert panel,” MDCG said.

The document also provides a template for notified bodies to follow for describing the type of a device when consulting with the expert panel, which follows the criteria for intended purpose and technology specified above.

If a notified body is presented with an IVD that would be the first certification for that type of device, but the expert panel is already in the midst of a consultation on a similar device, the notified bodies should wait to issue a certificate until the consultation is complete.

“These notified bodies should not issue the certificate until the consultation of the expert panel on the first certification for that type of device is completed and the views are published. It is highly recommended that the notified bodies should give consideration to the views of the expert panel in its decision to issue the certificate,” MDCG said.

MDCG

MDCG offers clarification on ‘first certification’ trigger for IVDR expert panel review

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