Gastrointestinal endoscopy devices and the European Union Medical Device Regulation: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement

Authors: Michael Bretthauer, Yuichi Mori, Jasmin Zessner-Spitzenberg, Michal F. Kaminski, Peter D. Siersema, Thierry Ponchon, Helmut Messmann Ian M. Gralnek, Raf Bisschops, Cesare Hassan

Abstract

Gastrointestinal endoscopy is largely dependent on medical devices. The European Union (EU) has recently introduced stricter rules and regulations for the approval of medical devices. This has consequences both for endoscopists and for patients.

The new regulations increase the need for clinical trials and observational studies for new and current devices used in endoscopy to ensure clinical benefit and reduce patient harm. European endoscopy environments should facilitate industry-sponsored clinical trials and registry studies to meet the demand for robust data on endoscopic devices as required in the new legislation. The European Society of Gastrointestinal Endoscopy (ESGE) will play an active role in the establishment of the new system.

The EU is establishing independent expert panels for device regulation in gastroenterology and hepatology, including endoscopy, that are charged with assessing the requirements for device testing. The ESGE encourages endoscopists with expertise in the technical and clinical performance of endoscopy devices to apply for expert panel membership. The ESGE has provided information for interested endoscopists on the ESGE website.

Private European companies called “notified bodies” are entitled to conduct device approval for the EU. The ESGE will actively engage with these notified bodies for topics related to the new endoscopy device approval process to ensure continued access to high quality endoscopy devices for endoscopists in Europe.

Introduction

All procedures in gastrointestinal (GI) endoscopy are dependent on medical devices. This includes endoscopes and processors, water, suction, and CO 2 pumps, and a large variety of disposable devices such as snares, knives, biopsy forceps, stents, ligation bands, clips, and needles. Without proper and immediate access to these devices, the field of GI endoscopy would not be able to function in its entirety.

The European Union (EU) introduced stricter rules and regulations for the approval of medical devices in their new Medical Device Regulation (MDR), which became effective in May 2021 [1]. The MDR includes a transition period in which devices approved under the previous EU legislation (the Medical Device Directive [MDD]) need to be re-certified. This transition period was originally scheduled to expire in May 2024; in January 2023, the EU commission extended the transition period until December 2027 or December 2028, depending on the device risk class.

After these deadlines, all medical devices in Europe, current and new ones, will require certification under the new stricter rules. Devices that are not re-certified or do not meet the bar under the new rules will no longer be available for endoscopists in Europe. This will have far-reaching consequences for both endoscopists, patients, and healthcare systems.

This ESGE position paper summarizes the new requirements, discusses its implications, and aims to raise awareness of the challenges and opportunities for endoscopy services in the EU