On 28 January 2019, the new Royal Decree of 19 DECEMBER 2018 on the liberalization of the distribution channel for medical devices has been published in the Belgian Official Gazette. The new Royal Decree will come into force on 7 February 2019.
The most important changes imply that, as of 7 February 2019, the Belgian distribution channel for Medical Devices and Active Implantable Medical Devices is no longer restricted to (hospital) pharmacies. From that date, patients and healthcare professionals can purchase medical devices, such as sterile bandages or physiological serum, directly from any distributor, from pharmacy to supermarket, and even directly from the manufacturer. The distribution of medical devices will also be facilitated for laboratories, nursing homes and private clinics. This liberalization should ensure that the access of end-users and patients to medical devices is better aligned with the principles of free movement of products with CE Marking within Europe. Nevertheless, the liberalization shall have no impact on the safety or efficacy of the medical devices on the Belgian market and does not affect the reimbursement conditions set by the RIZIV/INAMI.
In Belgium, all distributors and exporters must be registered with the FAMHP. For manufacturers, there is currently no direct obligation to register.
More information can be found here.