Reporting Modifications to Performance Studies of IVD Equipment under the IVDR

For modifications to clinical trials that have already been assessed by the MREC, the following application form for Article 58 and Article 70(2) trials must be used:

Application Form for Substantial Modifications

And the following application form for Article 70(1):

Application Forms for Substantial Modifications Art. 70(1)

When making modifications to trials, the original approved documents that are being amended should be included. Changes to the relevant documentation must be clearly identifiable.


Supplementary protocols for clinical trials with medical equipment for in vitro diagnostics, which were approved by a regional ethical committee before May 26, 2022, will continue to be processed by the approving regional committee.

Last updated 01-02-2024

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