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Endoscopy 2023; 55(06): 578-581
DOI: 10.1055/a-2052-2540
Position Statement

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

Michael Bretthauer
 1   Clinical Effectiveness Research Group, University of Oslo and Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
,
Yuichi Mori 
 1   Clinical Effectiveness Research Group, University of Oslo and Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
 2   Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
,
Jasmin Zessner-Spitzenberg
 3   Medical University Vienna, Vienna, Austria
,
Michal F. Kaminski 
 4   Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
,
Peter D. Siersema
 5   Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands
,
Thierry Ponchon
 6   Gastroenterology and Endoscopy Unit, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France
,
Helmut Messmann
 7   Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany
,
Ian M. Gralnek
 8   Ellen and Pinchas Mamber Institute of Gastroenterology and Hepatology, Emek Medical Center, Afula, Israel
 9   Rappaport Faculty of Medicine Technion Israel Institute of Technology, Haifa, Israel
,
Raf Bisschops 
10   Department of Gastroenterology and Hepatology, University Hospitals Leuven, and TARGID, KU Leuven, Leuven, Belgium
,
Cesare Hassan
11   Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
12   Endoscopy Unit, Humanitas Clinical and Research Center – IRCCS, Rozzano, Italy
› Author AffiliationsSupported by: European Union and the Health and Digital Executive Agency 101057099
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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.



Publication History

Article published online:
20 April 2023

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