Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.

Aim: To determine the level of evidence for innovative high-risk medical devices at market entry.

Methods: We reviewed all Belgian healthcare payer (RIZIV-INAMI) assessor reports on novel implants or invasive medical devices (n = 18, Class IIb-III) available between 2018 to mid-2019 on applications submitted for inclusion on their reimbursement list. We also conducted a review of the literature on evidence gaps and an analysis of relevant legal and ethical frameworks within the European context.

Introduction of high-risk medical devices: national measures that can be taken under the current European legislation to put the patient interest central.

High-risk medical devices may not always provide a therapeutic added value to patients. In Europe, no proof of efficacy is required to receive a CE label, making it difficult for policymakers to decide on reimbursement of (often expensive) high-risk medical devices. We explore, within the framework of the European legislation, the possibilities at a national level for a guided introduction of such devices.