Clinical Investigations with medical devices: which regulation applies

"Clinical investigation" is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device”.

Since the MDR does not specify details about ethics review of clinical investigations, it is thus necessary to check national requirements in relation to submission to the Ethics Committee regarding clinical investigations with medical devices. If applicable, the Ethics Committees and the Member State Competent Authorities, need access to the same versions of the updated technical documents.

Complying with the MDR does not remove the obligation of sponsors to comply with other relevant legislation issued by the European Union or Member States.

In addition to the MDR, there is other European Union legislation that may be applicable in a clinical investigation, depending on whether other products than devices are being studied in the same clinical study, such as the EU Regulation 536/2014 (Clinical Trial Regulation for Medicinal Products for Human use - e.g., combination products) and/or and EU Regulation 2017/746 (In Vitro Diagnostic Regulation).

Reference: MDCG 2021-6 Rev.1 pub Dec23 in accordance with MDR

Text: Ana Catarina Ribeiro Carrao