The European Medical Device Regulation – Advice to Endoscopy Services

Dr Michael Bretthauer

The new European Union (EU) rules for approval of medical devices is affecting our services.

• Increased need for clinical trials at European endoscopy centres
• Higher demand for robust data of endoscopic devices
• Better liaison of endoscopy centres with industry and regulators

The ESGE plays an active role in the establishment of the new system and supports endoscopists with relevant and updated information about the new rules and what they mean for our services, and for our patients.

More information:

ESGE Position Statement

Read the ESGE 2023 Position Statement on Endoscopy Devices and the European Union Medical Device Regulation here.

Apply for expert panel membership

The EU is establishing independent expert panels for device regulation in gastroenterology and hepatology, including endoscopy. We encourage European endoscopists with expertise in technical and clinical performance of endoscopy devices to apply for expert panel membership. Information on how to apply is available here.

Notified bodies

Private companies called “notified bodies” are entitled to conduct device approval for the EU. Find your nearest notified body-approved company here.