HomeHealthHealth CareUnveiling the Complexity of the Belgian MedTech Legal Landscape

Unveiling the Complexity of the Belgian MedTech Legal Landscape

The Belgian regulatory framework for medical devices is very complex and the already dense legal landscape was recently supplemented by the adoption of two new Belgian Royal Decrees: the Royal Decree of 25 September 2022 on performance studies with in vitro diagnostic medical devices and the Royal Decree of 13 September 2022 amending and repealing various provisions on in vitro diagnostic medical devices.

What impact will these new royal decrees have? This alert first gives you a structured overview of the existing regulatory framework and then focuses more specifically on the implications 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 Medical Devices Regulation 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 lays down the provisions regarding clinical trials on medical devices; and
  • The Royal Decree of 28 April 2021, which brings previous national rules into line with the Medical Devices Regulation.

The new royal decrees for in vitro diagnostic medical devices

On 26 May 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 with important updates to the European regulatory framework for in vitro diagnostic medical devices, including changes to the scope of performance studies or clinical studies with these devices.

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The Belgian legislator transposed the In Vitro Medical Devices Regulation through a law of 15 June 2022, which entered into force on 1 July 2022. The two newly adopted Royal Decrees mentioned above relate to this law and are important additions to the Belgian legislative landscape:

  • The Royal Decree of 25 September 2022 entered into force on 26 October 2022 and contains the provisions on performance studies with in vitro diagnostic medical devices; and
  • The Royal Decree of 13 September 2022 entered into force on 4 November 2022 and aligns previous national rules with the In Vitro Diagnostics Medical Devices Regulation.

The consequences of recent legislative changes

The Royal Decree of 25 September 2022 on the performance studies of in vitro diagnostic medical devices

This Royal Decree regulates the performance studies with in vitro diagnostic medical devices and includes coordinated assessment procedures for performance studies with Belgium acting as coordinating Member State.

Certain studies must now receive prior approval 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 involving surgically invasive sampling, ii) interventional studies, (iii) performance studies involving additional invasive procedures or other risks to subjects, and (iv) performance studies with companion diagnostics, and (v) performance studies involving medical devices for evaluate in vitro diagnostics, even if it falls outside the intended purpose.

Certain other studies must be reported 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 already carry the CE Mark and subject subjects to invasive and burdensome procedures in addition to those performed under the normal conditions of use of a such device, and ii) performance studies with concomitant diagnostics using only residual samples.

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Contrary to the In Vitro Diagnostic Medical Devices Regulation, the Belgian Royal Decree provides for a separate system for performance studies with in vitro diagnostic medical devices that are exclusively manufactured and used in healthcare institutions.

The Royal Decree also requires that substantial changes to regulated studies are reported to the FAMHP for approval and are subject to review by the ethics committee. In addition, the FAMHP, in collaboration with the Minister of Social Affairs and Public Health or his representative, is empowered to withdraw or suspend the study, or to require the sponsor of the performance study to change any aspect, if imposed requirements are not met. are complied with. Met.

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

This Royal Decree aims to repeal and amend several Royal Decrees relevant 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 amends several Royal Decrees applicable to other types of devices, such as medical devices or implants.

The Royal Decree thus modifies and specifies the tasks of the material monitoring contact points, which currently consist of i) immediately reporting serious incidents to the FAMHP and the distributors and/or manufacturers or their agents, ii) participating in investigations carried out by the FAMHP and in activities related to the safety of the use of devices, or iii) register and evaluate any serious incident or risk of serious incident resulting from a device in accordance with the procedure published on the website of the FAMHP (see article 3 of the Royal Decree of 15 November 2017 on the point of contact for material monitoring in hospitals and the registrations of distributors of medical devices).

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The Royal Decree further stipulates that economic operators must periodically confirm the correctness of the data of their device, and the FAMHP will inform any economic operator who does not do so that its activities may be suspended until this obligation is met. The Royal Decree also clarifies which information must be submitted to the FAMHP when requesting a deviation from the conformity assessment procedures. If the request is justified, the FAMHP can approve such a deviation 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 on medical devices).

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

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