Revealing the complexity of the Belgian legal landscape of MedTech

The Belgian regulatory framework for medical devices is very complex and the already dense legal landscape has recently been enriched by the adoption of two new Belgian royal decrees: the royal decree of 25 September 2022 relating to performance studies of diagnostic medical devices in vitro and the Royal Decree of 13 September 2022 amending and repealing various provisions relating to 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 more specifically address the consequences of these recent updates in the context of in vitro diagnostic medical devices.

The existing regulatory framework for medical devices

At European level, medical devices are regulated by Regulation (EU) 2017/745 (the Medical Devices Regulation), which replaced Directive 93/42/EEC (the Medical Devices Directive). The Belgian national measures for the implementation of the regulation on medical devices entered into force on May 26, 2021 and consist of the law of December 22, 2020 on medical devices, accompanied by three royal decrees:

  • The Royal Decree of May 12, 2021, which implements the provisions of the Belgian law of December 22, 2020;
  • The Royal Decree of 18 May 2021, which sets the provisions relating to clinical trials involving medical devices; and
  • The Royal Decree of 28 April 2021, which aligns previous national rules with the regulation on medical devices.

The new royal decrees for in vitro diagnostic medical devices

On May 26, 2022, Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation) entered into force, replacing Directive 98/79/EC (the In Vitro Diagnostic Medical Devices 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 regulation on in vitro medical devices by means of a law of June 15, 2022 which entered into force on July 1, 2022. The two newly adopted royal decrees mentioned above relate to this law and constitute additions important to Belgian legislation. countryside:

  • The Royal Decree of September 25, 2022 entered into force on October 26, 2022 and sets the provisions relating to performance studies of in vitro diagnostic medical devices; and
  • The Royal Decree of September 13, 2022 entered into force on November 4, 2022 and aligns previous national rules with the regulation on in vitro diagnostic medical devices.

The consequences of recent legal changes

The Royal Decree of 25 September 2022 relating to performance studies of in vitro diagnostic medical devices

This Royal Decree governs the conduct of performance studies involving in vitro diagnostic medical devices and includes coordinated assessment procedures for performance studies when Belgium acts as coordinating Member State.

Certain studies must now obtain prior authorization from the Federal Agency for Medicines and Health Products (FAMHP) and are subject to review by an ethics committee. These studies include i) performance studies in which invasive surgical specimen collection is performed, ii) interventional studies, (iii) performance studies involving additional invasive procedures or other risks to the subjects, and ( iv) performance studies involving companion diagnostics, and (v) performance studies that evaluate in vitro diagnostic medical devices even if outside the scope of their intended purpose.

Certain other studies must be notified to the FAMHP, but do not require prior authorization from the FAMHP and are not subject to review by the ethics committee. These studies include i) PMPF studies conducted to further evaluate in vitro diagnostic medical devices that are already CE marked and that involve subjecting subjects to invasive and cumbersome procedures additional to those performed under normal conditions of use of these devices, and ii) performance studies involving companion diagnostics using only remnant samples.

Unlike the regulation on in vitro diagnostic medical devices, the Belgian Royal Decree establishes a separate regime for performance studies involving in vitro diagnostic medical devices which are manufactured and used exclusively in healthcare establishments.

The Royal Decree also requires that substantial modifications to any regulated study be notified to the FAMHP for approval and submitted for review by the ethics committee. In addition, the FAMPA, in collaboration with the Minister of Social Affairs and Public Health or his representative, has the discretionary power to revoke or suspend the study, or to require the sponsor of the performance study to it modifies any aspect, if imposed requirements are not respected. meet.

Royal Decree of 13 September 2022 amending and repealing various provisions relating to in vitro diagnostic medical devices

This royal decree aims to repeal and modify various relevant royal decrees in the context of in vitro diagnostic medical devices in order to align the Belgian framework with the European level. In particular, this royal decree does not only apply to in vitro diagnostic medical devices but also modifies various royal decrees applicable to other types of devices, such as medical or implantable devices.

For example, the Royal Decree modifies and specifies the missions of the materiovigilance contact points, which currently consist of i) immediately informing the FAMHP and the distributors and/or manufacturers or their employees of any serious incident, ii) participating investigations carried out by the FAMHP and in the work related to the safety of use of the devices, or iii) record and assess any serious incident or risk of a serious incident due to a device, according to the procedure published on the website of the FAMHP (see article 3 of the Royal Decree of 15 November 2017 relating to the materiovigilance contact point in hospitals and the registration of distributors of medical devices).

The Royal Decree further specifies that economic operators must periodically confirm the accuracy of their device data, and the FAMHP will inform any economic operator that does not do so that its activities may be suspended until this obligation is fulfilled. respected. In addition, the Royal Decree specifies which information must be submitted to the FAMHP when requesting a derogation from the conformity assessment procedures. If the request is justified, the FAMHP may approve such a derogation in the interest of public health or patient safety (see article 8/1 and article 9 of the Royal Decree of 12 May 2021 implementing the law of 22 December 2020 relating to medical devices).

The Belgian legislator will undoubtedly continue to make changes to this already dense and complicated regulatory framework in order to bring it into line with European Union legislation. We will continue to monitor these developments and our Crowell & Moring MedTech team is here to answer any questions you have and to provide you with ongoing updates.

Sharon D. Cole