Join the Sponsor Webinar for the COMBINE ‘All-in-One’ coordinated procedure for combined studies on 20 June

📅 Save the Date! Join the Sponsor Webinar for the COMBINE ‘All-in-One’ coordinated procedure for combined studies on 20 June!

Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
In the EU, there are legal requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostics (IVDs).

These requirements are laid out in Regulation (EU) 536/2014 on clinical trials on medicinal products for human use (CTR), Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) respectively.

These Regulations may need to be applied together to develop innovative treatments combining medicinal products with medical devices or IVDs.

Following the COMBINE programme analysis report, the COMBINE PILOT on coordinated assessment is being launched. This initiative aims to streamline the review process for multinational clinical trials with a simultaneous performance study by synchronising competent authority and ethics committee reviews.

🔑 Key Details:

• Learn about the pilot for the ‘All-in-One' procedure
• Pilot Sponsor Guide will be published in June 2025
• Call for expression of interest will be published in June 2025
• Webinar on 20 June, 14:00-16:00 CEST – perfect for potential sponsors. Tune in via the link below.

Find out more about the COMBINE Programme here:
🔗Sign up now: https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies_en