On 15 February 2023, the European Parliament has almost unanimously supported a proposal to amend the EU Medical Devices and In Vitro Diagnostic Medical Devices Regulations, which introduces a longer transition period for the recertification of medical devices. The European Commission's proposal was approved, in agreement with the Swedish Presidency of the EU Council, without any amendments.
Under certain conditions, the amendment allows for an extension of the time by which manufacturers have to re-certify their devices. The second most important change brought by the amendment is the removal of the so-called "sell-off" date, which will also help distributors.
The specific new dates are as follows:
Until 26 May 2026, for custom-made risk class III implantable devices
Until 31 December 2027, for Class III devices and Class IIb implantable devices with a few partial exceptions with a valid certificate under the directive (higher risk devices such as pacemakers or hip implants)
until 31 December 2028, for other Class IIb devices and Class IIa, Class I sterile or Class I devices with a measuring function with a valid certificate under the existing Directives
However, as it was already mentioned above, only manufacturers who have already started preparing for the re-certification process will be subject to these prolongations. Such a manufacturer must implement a new quality management system in accordance with the MDR by 26 May 2024 at the latest, and by the same date it or its authorized representative must also submit a formal application for the start of certification of the device concerned, or the device to replace it, to a notified body designed under MDR, and the manufacturer must also conclude a written certification agreement with that body by 26 September 2024 at the latest.
The legislative amendment also abolishes the provision with a one-year deadline, i.e. until May 26, 2025, for the sell-off of medical devices that will be legally on the market by May 26, 2024, the original deadline for the end of the transition period, and have not yet been recertified. Otherwise, they would have to be withdrawn from the market and disposed of after this deadline. The same applies to in vitro diagnostic medical devices.
The amendment allows for two possibilities when an expired certificate is renewed. The first option is the signing of a contract between the manufacturer and a notified body appointed under the MDR for re-certification. The second option is the granting of an exemption from the conformity assessment by the competent national authority in accordance with Article 59 of the MDR or the procedure under Article 97 of the MDR, whereby the competent national authority may require the manufacturer to carry out the conformity assessment procedure within a specified period of time for a device found to be non-compliant. In our opinion, such a setup is not completely seamless.
Several pitfalls arise here. Firstly, it is generally accepted in legal theory that a time limit or a period that has already expired cannot be extended. Furthermore, it should be noted that the granting of exemptions from conformity assessment is the responsibility of the competent national authorities and their validity is territorially limited to the territory of the Member State concerned. It is up to the Member State concerned to decide how to approach the issue - some Member States do not grant exemptions in practice (e.g. the Czech Republic), while others make excessive use of this possibility (e.g. France). However, according to the proposal, contrary to the prohibition of extraterritorial validity of an exemption granted, the exemption would automatically revalidate an expired certificate and the product could thus be traded throughout the EU. JUDr. Veronika Moravová, LL.M., Porta Medica
The amendment will take effect immediately upon publication in the Official Journal – the commonly used 20-day waiting period will be skipped, due to its urgent nature. When this happens, we will inform you immediately.
Author: Aneta Jaroschyová