Belgium Complements and Updates National Regulatory Framework on In Vitro Diagnostic Medical Devices
- 26/10/2022
- Articles
On 25 October 2022, the Belgian Official Journal published two Royal Decrees complementing and implementing the regulatory framework governing in vitro diagnostic medical devices as based on Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices (the IVDR) and the Belgian Law of 15 June 2022 on in vitro diagnostic medical devices (the Law of 15 June 2022).
First, a Royal Decree of 13 September 2022 “amending and repealing various provisions regarding in vitro diagnostic medical devices” which repeals and updates provisions in a wide range of Royal Decrees to bring them in line with the IVDR and the Law of 15 June 2022 as well as with Regulation (EU) 2017/745 of 5 April 2017 on medical devices and the Belgian Law of 22 December 2020 on medical devices. Except for its Article 7, the Royal Decree of 13 September 2022 will enter into force on Friday 4 November 2022.
Second, a Royal Decree of 25 September 2022 “on performance studies concerning in vitro diagnostic medical devices”. As its title indicates, this Royal Decree implements the IVDR and the Law of 15 June 2022 as regards performance studies, i.e., studies undertaken to establish or confirm the analytical or clinical performance of a device. Articles 2 through 23 of the Royal Decree set forth rules on performance studies as meant in Article 58(1) and (2) IVDR (this includes, amongst others, performance studies involving invasive procedures on the study subjects and performance studies involving companion diagnostics) and in Article 70 IVDR (i.e., performance studies regarding devices bearing the CE marking). Articles 24 through 34 of the Royal Decree, in turn, introduce specific requirements for performance studies involving devices which are manufactured and used exclusively in healthcare institutions. The Royal Decree of 25 September 2022 enters into force on 26 October 2022.
Both Royal Decrees and the related opinions of the Council of State are attached.
