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KCE Reports 402C (2025)

KCE Reports 400C (2025) In Belgium, cost-effectiveness is one of the criteria used by public authorities to assess applications for reimbursement of medicines and Class 1 medical devices, i.e. products for which the applicant claims added therapeutic value and for which a higher price may be charged.

KCE Reports 347C (2021) To obtain marketing authorisation for the European market, any new product must provide evidence of its quality, safety and efficacy. For high-risk medical devices (e.g. implants), the requirements are less strict.