The Commission is preparing a legislative amendment to address MDR implementation challenges
Medical Device Regulation 2017/745 (MDR) 2021 and In Vitro Diagnostic Regulation 2017/745 (IVDR) 2022 have brought significant changes to the legislation on medical devices. These changes also affect medical devices already on the market because they have to be updated to comply with the new requirements. According to the current estimate, several manufacturers have challenges in meeting the requirements during the transitional periods. In addition to late preparation for the changes, these challenges are brought by a lack of supporting elements for the implementation of the Regulation: for example, there are not enough notified bodies, as referred to in MDR and IVDR, the operation of expert panels started rather late, and the necessary reference laboratories for high-risk IVDs are not available. The joint European database (Eudamed) is also delayed.
Because of this, it is possible that the availability of some medical devices of risk class II–III will change when the transitional periods for the MDR will gradually come to an end. Together with the European Commission, authorities are actively seeking solutions to remove the challenges related to the implementation of the MDR and to mitigate the risk related to the availability of medical devices. Fimea actively participates in seeking solutions at the EU level with the aim of solving this challenging and complex situation and ensuring patient safety. Several proposals have been made to mitigate the risk of limited availability, and these proposals have been discussed in Medical Device Coordination Group’s (MDCG) meeting of 24–25 October 2022 and extraordinary meeting of 17 November 2022. To prevent potential problems with availability, the transitional periods of IVDR were already modified at the beginning of 2022 by amending Regulation 2022/112.
The medical device legislation does not include mechanisms allowing the supervisory authority to collect information or control the availability of medical devices. If problems with availability are suspected, it is important to first contact the manufacturer of the device to the discuss matter. It is also important to keep in mind that medical devices already acquired for patient use can be used normally after the end of the MDR and IVDR transitional periods, because these Regulations only set requirements for placing on the market of medical devices (i.e. manufacture) and making them available (i.e. distribution). Fimea would also like to remind that, with regard to device-specific exceptions, the assessment of patient safety by authorities takes several months.
Stella Kyriakides, Commissioner for Health and Food Safety, provided a state-of-play on the implementation status and proposed solutions that are under consideration at the European Parliament Plenary Session of 24 November 2022. You can read the speech by Stella Kyriakides, Commissioner for Health and Food Safety, at the EU Press Corner: https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_22_7145
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices
Fimea news: Medical Device Coordination Group (MDCG) guideline 2022–14 on addressing the challenges in implementing the MD and IVD Regulations (in Finnish)
What is Medical Device Coordination Group (MDCG)? Overview (europa.eu)
Ytterligare information ges av
- Susanna Peltoniemi, Head of Unit, Medical Devices, tel. +358 29 522 3270
- Jari Knuuttila, Chief Specialist, Medical Devices, tel. +358 29 522 3274
- Nelli Karhu, Senior Inspector, Medical Devices, tel. +358 29 522 3276
- Johanna Nystedt, Director, Supervision and Licences, tel. +358 29 522 3210
- E-mail address format: firstname.lastname@example.org