Medical devices and in-vitro medical devices: News and forthcoming provisions
In recent days there have been developments in the regulatory framework for medical devices and in-vitro medical devices via the proposal of the European Commission for the amendment of the Medical Device Regulation[1] (“MDR”) and the In-Vitro Medical Device Regulation[2] (“IVDR”) and the new guidance of the Medical Device Coordination Group (“MDCG”). These new and forthcoming provisions focus on the transitional provisions of both the MDR and the IVDR, with the aim of addressing issues arising from implementation of the two regulations.
The new proposal of the European Commission amending the MDR and the IVDR
The European Commission’s proposal[3] of January 23, 2024 (“Proposal”) amends the MDR and the IVDR by introducing new provisions on a variety of subjects. On May 31, 2024, the European Economic and Social Committee (“EESC”) issued a favorable opinion on the Proposal, bringing it one step closer to final approval.
These are the main provisions included in the Proposal:
- Gradual roll-out of Eudamed: The Proposal lays the groundwork for a gradual roll-out of the electronic systems integrated into the European database of medical devices (“Eudamed”) without waiting for the implementation of all six modules, as currently provided by the regulations. According to the Commission and the EESC, the gradual implementation of Eudamed (especially its systems for registration of economic operators, devices, and certificates) will improve transparency and provide information on devices on the EU market, helping authorities monitor their availability.
- Information obligation in case of interruption of supply: The Proposal newly requires manufacturers to give advance notice before halting the supply chain of medical devices and in-vitro medical devices. Under the Proposal, a manufacturer must give advance notice to the appropriate authorities of its Member State and economic operators and health institutions and healthcare professionals to whom it directly supplies devices. An authority that receives the information then must promptly inform the appropriate authorities of other Member States and the European Commission; for their part, economic operators shall inform without undue delay any other operators, healthcare institutions, or professionals to whom they direct supply the devices.
- Extension of transitional provisions for certain in-vitro diagnostic medical devices: Lastly, the Proposal is designed to extend the transitional period for certain in-vitro medical devices through December 31, 2029,[4] at the latest,[5] by introducing requirements similar to those already provided for medical devices by Article 120 MDR. This provision is intended to mitigate the risk of shortages of in-vitro devices, and it is particularly important for high-risk devices, such as those used to test blood for infections and identify blood groups for transfusions.
Because of the urgency of the matter, the European Commission provided that if the amendments to the MDR and the IVDR are approved they will enter into force immediately on the date of their publication.
MDCG guidance on oversight regarding the transitional provisions under Article 120 MDR
On May 27, 2024, the MDCG issued new guidance[6] on appropriate oversight in relation to the transitional provisions under Article 120 MDR for devices covered by certificates under the Medical Device Directive[7] (“MDD”) and the Active Implantable Medical Device Directive[8] (“AIMDD”).
The new guidance outlines the activities that should be carried out by notified bodies as part of the oversight under Article 120 (3e) (which is one of the conditions to benefit from the transitional period, i.e., to place on the market/put into service devices covered by a valid certificate under the MDD and the AIMDD after the date of application of the MDR). The new guidance also includes requirements for manufacturer quality management system obligations.
[1] Regulation 2017/745.
[2] Regulation 2017/746.
[3] Proposal of the European Commission 2024/0021 of January 23, 2024 (see here).
[4] The IVDR has applied since May 26, 2022. In January 2022, the European Parliament and the European Council adopted a staggered extension of its transitional period, ranging from May 26, 2025 for high-risk IVDs to May 26, 2027 for lower risk IVDs, and to May 26, 2028 for certain provisions concerning devices manufactured and used in healthcare institutions.
[5] The Proposal foresees different deadlines for the different kinds and classes of in-vitro medical devices.
[6] MDCG Guidance of May 27, 2024 (see here).
[7] Directive 93/42/EEC.
[8] Directive 90/385/EEC.
