State of implementation of the MD and IVD regulations discussed at ministerial level

The Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council discussed the French initiative to support the implementation of the MD and IVD regulations and to plan new actions to make available the significantly delayed European database EUDAMED. Minister Sanni Grahn-Laasonen from Finland attended the EPSCO meeting. The meeting was held on 30 November 2023.

The initiative has raised concerns about the significant backlog of structures supporting the MD and IVD regulations, which could at worst jeopardise the availability of medical devices in Europe. The initiative proposes new measures to speed up the EUDAMED timetable. Finland was one of nine countries to support the French initiative. 

Fimea is actively participating in the debate with other competent authorities in the Member States to address the challenges of implementing the regulations. Fimea supports the proposal to find a procedure for the rapid implementation of EUDAMED. Fimea considers it important that EUDAMED be provided with a comprehensive collection of sufficient information on CE-marked medical devices. The collection of such information will enable the promotion of patient safety and provide a basis for mapping the availability of equipment. The information collected in EUDAMED will also enable effective market surveillance.

Read more:

Medical devices

MD Regulation EU/2017/745

IVD Regulation EU/2017/746

Summary of the EPSCO meeting on the Commission website: Employment, Social Policy, Health and Consumer Affairs Council (Health) - Consilium (europa.eu)

Medical devices initiative text on the Commission's website (pdf)