New distribution rules for medical devices in Belgium
Since 7 February, certain medical devices and active implantable medical devices can be sold in Belgium not only via pharmacies but also via other distribution channels such as supermarkets, para-pharmacies or directly by manufacturers. This is the outcome of the recently adopted legislation liberalising the distribution of medical devices in line with the principle of the free movement of CE-marked products in the EU.
What is the impact of the new rules?
The distribution of medical devices in Belgium used to be a prerogative of certain specific healthcare professionals (e.g. (hospital) pharmacists or dentists). This restriction was considered by the authorities as no longer adapted to the existing standards, and medical and patients’ needs.
The new rules have opened up the market and make it now possible for medical device companies to use any distribution channel, such as supermarkets or para-pharmacies. Healthcare professionals and patients can also purchase certain medical devices directly from manufacturers. The distribution has this way moreover become easier for laboratories, elderly houses and private clinics.
Which medical devices benefit from the liberalisation?
The following types of medical devices can be freely distributed:
- Sterile medical equipment in contact with the patient (e.g. dressings, compresses);
- Sterile injections, infusions, transfusions or drainage equipment, catheters and probes, any equipment for medical and obstetrical procedures presented as sterile, including irrigation solutions and haemodialysis concentrates;
- Implantable medical devices (sterile or not);
- Medical devices for birth control and/ or the prevention of sexually transmitted diseases;
- Devices that are similar to medicinal products and/or have been previously registered;
- Devices that are used in dentistry, including custom-made devices (e. g. amalgam, crowns, prostheses), as well as systems and kits made of these devices; and
- Systems and kits comprising of the devices mentioned above. The new distributors must adhere to the same safety, quality and traceability requirements as pharmacists and dentists. They are therefore required to register with the relevant Belgian authority, the Federal Agency for Medicines and Health Products.
- The liberalisation has no consequences on the conditions for reimbursement of medical devices. Medical devices upon prescription continue to be reimbursed only if purchased in a pharmacy.
Are there any restrictions?
The new liberal approach of the Belgian system is now in line with what has been in place in other EU countries for many years.
StéphanieDe SmedtSenior associate Attorney at Law
Stéphanie De Smedt is senior associate within the Litigation & Risk Management Practice Group of our Brussels office.
She is head of the IP/IT & Data Protection Team in Belgium and is team leader of the firm-wide Healthcare and Life Sciences Team.