Reporting Modifications to Clinical Investigations of Medical Devices under the MDR

See guidance on reporting changes:

Guidance on Reporting Modifications in Approved Trials of Medical Devices

For modifications to trials that have already been assessed by the MREC, the following application form for Article 62 and 74(2) must be used:

Application Form for Substantial Modifications to Trials of Medical Equipment (Article 62)

And the following application form for Articles 74(1) and 82:

Application Form for Modifications to Trial Protocol in Connection with Trials of Medical Equipment (Article 82)

Overview of the Most Common Changes in a Trial Protocol

See the list of the most common changes in a trial protocol

Last updated 01-02-2024

Please note that the text on this page has been translated with the help of AI. If you find any errors in the text or something is unclear, please contact us for clarification.