Authors' objectives: The study focuses on the legally acceptable possibilities for a guided introduction of high-risk medical devices (class III and implantable devices) after their CE-marking in Belgium. The research questions are as follows: - What are the existing legal opportunities in a selection of European countries, including Belgium, to introduce a high-risk device on the market in a guided manner (e.g. concentrate expertise, collect relevant data, etc.)? - Which legislative initiatives in Belgium are necessary to apply one or more (if any) of the above identified possibilities and new possibilities to have a guided introduction of CE-labelled devices (which are not in conflict with European law)? The study focuses on the legal possibilities and opportunities to implement a higher protection of the patients in the phase after the high-risk device or implant received a CE marking and before policy makers decide on reimbursement. With this aim, the study focuses on the regulation of the "devices" themselves and the "medical care/use" associated with the products. The financial barriers such as conditional reimbursement and/or research funding are thus out of the scope of this report.c The study also excludes the liability for defective products that may apply to medical devices manufacturers.d The post-market surveillance system is also of importance but falls outside of the scope since this is rather an a posteriori control while this report focusses on an a priori control on patients' safety and benefit before the product is widely spread on the market.

Authors' recommendations: The various measures proposed are all partial. They answer different parts of the issue. Their direct effect is sometimes less important than their induced effect. We believe that these measures should be seen as a whole to increase knowledge of the devices in question in order to, ultimatly, set, on the basis of this knowledge, enlightened health and reimbursement policies.

Project Status: Completed

Year Published: 2015

URL for published report: http://kce.fgov.be/sites/default/files/page_documents/KCE249_High-risk%20medical%20devices_Report.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Belgium

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

Copyright: Belgian Health Care Knowledge Centre (KCE)