MDCG offers guidance on Class D tests during IVDR transition

Regulatory NewsRegulatory News | 09 April 2021 |  By 

The European Commission’s Medical Device Coordination Group (MDCG) on Friday issued guidance on how certifications of the highest risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) will be handled during the transition period that runs until 26 May 2022.
Under IVDR, diagnostics are divided into four classes, A, B, C and D, from lowest- to highest-risk, based on their intended purpose and their inherent risks, with certain requirements applying only to the higher risk classes. High-risk class D IVDs are subject to additional scrutiny and may need to be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL) against common specifications. (RELATED: MDCG releases long-awaited IVD classification guidance, Regulatory Focus 13 November 2020).
While members have already been appointed to the IVD expert panel, EURLs have yet to be designated and the Commission is still working to issue several implementing acts related to the laboratories and the fees they may charge.
During the transition period, MDCG says that notified bodies may accept applications from manufacturers for class D IVDs but cannot issue certifications before the expert panel is operational or before the panel has provided its views on devices that require consultation.
When expert panel consultation is required, notified bodies must submit performance evaluation reports from manufacturers to the expert panel within five days of receiving the reports. However, if the expert panel is not yet functional, MDCG says that notified bodies should submit the reports within five days of the panel becoming operational.
MDCG also says that guidance is coming to help notified bodies determine whether IVDs must undergo expert panel consultation when the certification would be the first for a specific type of device and where no common specifications exist.
“MDCG guidance is in preparation on what constitutes a ‘type of device,’ as well as on the process that notified bodies should follow to determine whether a given certification is the first one for that type,” MDCG writes.
As for the timeframe for notified bodies to receive the expert panel’s views, MDCG points to Article 48(6) of IVDR, which requires experts to provide their views within the deadline for delivery of the scientific opinion by the EURL. If there is no designated reference laboratory for a particular IVD, the expert panel should still provide its views within 60 days.
Notified bodies may also accept applications and issue certificates for class D IVDs during the transition even if a EURL has not been designated for a diagnostic. Such certificates will remain valid until their expiry date, even if a reference laboratory is designated for the device at a later date. Manufacturers and notified bodies are, however, instructed to follow EURL-related provisions for sample and batch testing from the time a EURL becomes operational. “For performance verification, the notified body should follow the EURL-related provisions of Section 4.9 of Annex IX or Section 3(j) of Annex X at the time of the re-certification in line with Section 4.11 of Annex VII. So, the procedure set out in paragraph 5 of Article 48 involving an EURL will be applied at the time of re-certification,” MDCG writes.


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Tags: EU, IVDR, IVDs

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