New Belgian Royal Decree liberalises the distribution of medical devices

On 7 February 2019, the Royal Decree on the liberalisation of the distribution channel of medical devices became applicable (published in the Belgian Official Journal on 28 January 2019). The Royal Decree revokes certain articles in existing Royal Decrees relating to medical devices and two Ministerial Decrees implementing those articles, all of which restricted the distribution channels for certain medical devices in Belgium.

Specifically, the Royal Decree removes Article 19 from the Royal Decree on active implantable medical devices, which restricted the reception, storage and sale of active implantable medical devices to hospital pharmacists. "Active implantable medical devices" are devices which are implanted in the human body via medical intervention, designed to stay in the human body for a certain amount of time and are dependent on an energy source. Examples include pacemakers and defibrillators.

In addition, the Royal Decree removes certain paragraphs of Article 10-bis from the Royal Decree on medical devices which also restricted the reception, storage and sale of specific medical devices to specific healthcare professionals, that is, certain sterile medical materials (such as dressings, compresses or injection materials), implantable devices (whether or not sterile), birth control and/or sexually transmitted diseases prevention devices and devices related to medicines or which used to be subject to registration.

These changes may significantly impact the way these categories of medical devices will be marketed in Belgium, as new actors, such as supermarkets or the manufacturers of the medical devices themselves, will be able to enter the distribution and sales markets for the devices. These actors should of course comply with other legislation relating to medical devices.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2019 Issue (Thomson Reuters).