Unveiling The Complexity Of The Belgian MedTech Legal Landscape

• Published date: 18 November 2022
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Biotechnology & Nanotechnology
• Law Firm: Crowell & Moring
• Author: Mr Kristof Roox, Jurgen Figys and Wietse Vanpoucke

The Belgian regulatory framework for medical devices is highly complex, and the already dense legal landscape was recently added to by the adoption of two new Belgian royal decrees: the Royal Decree of 25 September 2022 relating to performance studies involving in vitro diagnostic medical devices and the Royal Decree of 13 September 2022 amending and repealing various provisions regarding in vitro diagnostic medical devices.

What impact will these new Royal Decrees have? This alert will first provide you with a structured overview of the existing regulatory framework and then look more specifically at the consequences of these recent updates in the context of in vitro diagnostic medical devices.

The existing regulatory framework for medical devices

At a European level, medical devices are regulated by Regulation (EU) 2017/745 (the Medical Device Regulation), which replaced Directive 93/42/EEC (the Medical Device Directive). Belgian national measures to implement the Medical Device Regulation came into effect on 26 May 2021, and consist of the law of 22 December 2020 on medical devices, accompanied by three royal decrees:

• The Royal Decree of 12 May 2021, which implements the provisions in the Belgian law of 22 December 2020;
• The Royal Decree of 18 May 2021, which sets out the provisions regarding clinical trials involving medical devices; and
• The Royal Decree of 28 April 2021, which aligns previous national rules with the Medical Device Regulation.

The new royal decrees for in vitro diagnostic medical devices

On 26 May 2022, Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Device Regulation) came into force, replacing Directive 98/79/EC (the In Vitro Diagnostic Medical Device Directive) and introducing major updates to the European regulatory framework for in vitro diagnostic medical devices, including changes to the scope of performance studies or clinical studies involving these devices.

The Belgian legislator transposed the In Vitro Medical Device Regulation by means of a law of 15 June 2022 that came into effect on 1 July 2022. The two newly adopted royal decrees mentioned above relate to this law, and they are important additions to the Belgian legislative landscape:

• The Royal Decree of 25 September 2022 came into effect on 26 October 2022 and sets out the provisions regarding performance studies with in vitro diagnostic medical devices; and
• The Royal Decree of 13 September 2022 came into effect on 4 November 2022 and aligns previous...