A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR) poses a challenge for sponsors conducting combined studies of different types of products subject to these regulations. Each regulation has different rules and criteria that apply to clinical research of medical products in the EU, according to a recent study released under the COMBINE initiative.
The report was developed with input from the European Commission, the national competent authorities, ethics committees, the European Medicines Agency (EMA), and other stakeholders.
The COMBINE project was launched in June 2023 to “address the growing number of challenges identified when conducting combined studies in Europe,” said a March 2024 presentation on the project released by the European Commission’s D.2 unit on medical products and the D.3 unit on medical devices…
