New Belgian legislation on medical devices and in vitro diagnostics comes into force – Osborne Clarke
The transposition of EU medtech regulations is progressing in Belgium – with repercussions for all medtech companies active there.
Two new decrees on medical devices were published in the Belgian Official Gazette of October 25, 2022. While the decrees are presented as concluding the implementation of the European regulations on in vitro diagnostics (IVD) in national laws, a careful examination of their provision shows that they have a much broader scope – with repercussions for all medtech companies active in Belgium.
Implementation of European regulations on medical technologies
The first efforts to transpose the European MDR in Belgium took place last year with the entry into force of a fourfold legal and regulatory framework: the MDR law, published on January 19, 2021 and three decrees published only a few days before the date of the application MDR (May 26, 2021):
- the decree of application of the MDR intended to concretize the principal provisions of the law MDR;
- the clinical investigations decree, specific to studies carried out with medical devices for various purposes, some of which are not covered by the MDR;
- the MDR Repeal and Amendment Order was needed to clean up the local legacy device rules and align them with the new post-MDR framework.
Implementation of European IVD regulations
In vitro diagnostic medical devices are regulated by the IVDR, which, although (partially) applicable throughout the EU since May 26, 2022, has been deployed with significant delays with regard to the Belgian legal framework :
As is the case for the other medical devices governed by the MDR, the IVDs captured by the IVDR and placed, made available or put into service on the Belgian market are governed by a law: the IVDR law, published on 30 June 2022.
In addition, the two executive orders issued last week are:
- the performance studies decree, applicable since October 26, 2022;
- the decree repealing and amending the IVDR which will come into force on November 4, 2022.
An IVDR implementing decree reflecting the MDR implementing decree remains to be published.
IVDR Repeal and Amendment Order
The decree repeals provisions and adapts references in various legacy decrees (such as the IVDD implementing decree) on the grounds that in vitro diagnostic medical devices are now governed by the European IVDR instead of legislation legacy, with substantial changes limited to their regulatory framework.
Contrary to what its name suggests, the decree is not specific to IVDs and also covers other types of devices. In addition, the decree repeals provisions and adapts references in other decrees on the grounds that medical devices are now governed by the MDR, independently of the provisions of the IVDR.
The vigilance contact point (PCV) decree of 15 November 2017 was amended by the decree to define and align the missions of the PCVs according to the Belgian MDR law and the Belgian IVDR law. Interestingly, in the current state of the updated VCP decree, medical device distributors (IVDs) now find themselves without any local legal basis requiring them to appoint a VCP within their organizations.
The GDP guidelines issued by the local regulator (the Federal Agency for Medicines and Health Products or famhp) provide for such a requirement. However, it does not define the duties of the VCP and “compliance is not mandatory”.
Both the MDR and the IVDR impose general vigilance requirements on distributors, but both the registration of distributors and the supervision of their vigilance activities by competent authorities remain a competence of the Member States under EU law. Further information on the local specificities of the VCP is available on the famhp website (Dutch version – French version).
The decree creates a new section in the implementing decree of the MDR entitled “Registration of manufacturers, agents and importers”. This new section deals with the sanctions that can be imposed on economic operators who have not confirmed the accuracy of the data they have entered on Eudamed (the European online database of medical devices developed by the European Commission) such as the demands the MDR. If a violation of this MDR requirement is confirmed, famhp may take corrective action by suspending the operators’ activities until they become compliant.
Eudamed data must be confirmed no later than one year after the first submission, and then every two years (Article 31(5) of the MDR).
Producers and sterilizers of systems and procedure packs are bound by different Eudamed registration requirements (MDR Article 29(2)).
The local registration conditions on the famhp portal remain unchanged by the decree.
The procedure for requesting exemptions to Article 59 has been clarified. Article 59 of the MDR (Derogation from conformity assessment procedures) grants competent national authorities such as the famhp the power to authorise, upon duly justified request, the circulation on their territory of devices which are not ( yet) CE marked.
In Belgium, this procedure – which gained popularity during the Covid-19 pandemic and continues to be used by economic operators struggling with notified body bottlenecks – can only be triggered by manufacturers, agents or those duly authorized by them. The decree specifies the minimum information that applicants must provide, far from the complex application forms that they will have to fill out in practice to meet the requirements of the regulator (see the standard form and the patient-specific form).
Performance studies decree
The new decree regulates the conduct of performance studies in Belgium, including when Belgium acts as “Coordinating Member State” or “Member State concerned” in accordance with Article 74 of the IVDR (Coordinated Evaluation Procedure performance studies).
Prior authorization and review by the ethics committee
It submits the following studies to prior authorization by the famhp and to an examination by the ethics committee (EC) according to the distribution of responsibilities listed in appendix Ia of the decree (see our extract in Dutch – French):
- Performance studies involving invasive removal, interventional clinical performance studies and performance studies involving additional invasive procedures or other risks to subjects (Article 58(1) IVDR);
- Performance studies involving companion diagnostics (including those using leftover samples only) (Article 58(2), first sentence of the IVDR).
A separate and specific authorization procedure is established by the decree relating to performance studies of devices manufactured and used in healthcare establishments (Article 5 (5) of the IVDR). Requests for authorization must follow the outline of appendix IV (see our extract in Dutch – French).
EU law is silent on the regulatory framework applicable to such studies. The national specificities provided for in Chapter 3 of the decree have been applied in accordance with Articles 34 and 36 of the Treaty on the Functioning of the European Union by the Belgian Council of State.
Opinion and review of the ethics committee
Under the new decree, the following studies are not subject to prior authorization but must be notified and subject to an EC opinion according to the checklist in Annex II (see our extract in Dutch – French) of the decree:
- PMPF studies, which consist of subjecting subjects to procedures complementary to those performed under normal conditions of use of the device, when these complementary procedures are invasive or costly (article 70 of the IVDR).
PMPF studies are performance studies conducted to further evaluate, within the scope of its intended use, an IVD device that already bears the CE mark. For greater clarity, the performance studies carried out to evaluate a device that already bears the CE marking, outside the scope of its intended purpose, are subject to the famhp/CE authorization procedure mentioned above.
In accordance with the IVDR, the decree also requires that the following studies be notified to the famhp by their sponsor:
- Performance studies involving companion diagnostics using only leftover samples (Article 58, paragraph 2, second sentence of the IVDR).
A model notification form is provided in appendix III (see our extract in Dutch – French), mistakenly called “request form” in article 21 of the decree. As part of this notification, the study protocol and informed consent documentation must also be provided to the regulatory body, unless this documentation has already been approved by an EC under the Health and Safety Act. human experiments. In order to use the remaining samples in a performance study, informed consent from the patient must have been obtained at the time of sample collection according to the regulator. Sponsors must therefore provide famhp with proof that consent has been obtained.
Substantial changes to the above studies are generally subject to notification to famhp and review by the EC. This means that the famhp is also involved, for example, in the examination of substantial modifications of the PMPF studies mentioned above with the EC; the two bodies are responsible for examining the appropriateness of the modifications in accordance with appendix Ib of the decree (see our excerpt in Dutch – French).
A certain number of corrective measures can be taken by the famhp in collaboration with the Ministry of Health when non-conformities are identified. These range from requests to change any aspect found to be non-compliant, to suspending or stopping performance studies, to revoking relevant permissions, where applicable. The decree specifies the applicable procedure and the rights of the sponsors, in particular that of expressing themselves before a measure is taken.
Commentary by Osborne Clarke
The two new decrees aim to solidify the Belgian regulatory framework in the post-MDR/IVDR era. Although labeled as IVD-specific legislation, it was partly used to align national legislation with a number of MDR changes and requirements that are not specific to IVD companies, months after the May 2021 deadlines. and May 2022. The old legislation enacted before the MDR/IVDR coexists with these new requirements in a disparate but extremely dense regulatory framework where local specificities and the implementation of the EU acquis merge. This configuration should encourage companies active in the local market to monitor their steps in the construction of their regulatory strategy. Delays in the implementation of EU regulations and inconsistencies between updated rules and the regulator’s website support this recommendation. Belgium is one of the top 10 countries in the European IVD market and in the medical device market (MedTech Europe, The European Medical Technology Industry in figures 2022).
- Relevant legislation in French and Dutch