Public consultation: Evaluation of the EU Medical Device Regulations - comments must be submitted by 21 March 2025

The MDR and IVDR were adopted in 2017 to enhance safety and efficiency of medical devices marketed in the EU. As the MDR and IVDR introduced significant changes, the regulations introduced transition periods until the full implementation of the new legislation on medical devices. 

In view of the significant challenges encountered by the industry in transitioning to the new rules, the European Commission has initiated a targeted evaluation of the regulations. 

The evaluation comes after much pressure to revise the MDR and IVDR as expressed by EU member states and the European Parliament and in industry feedback. A key challenge with the current regulations is the complexity and length of the regulatory procedures, which have led to delays in the certification and approval of medical devices and in vitro diagnostics.

The European Parliament has requested that the EU Commission propose specific solutions to the raised challenges of the regulations and their implementation. Consequently, the EU Commission now launches its first evaluation of the MDR and IVDR. In particular, the evaluation will focus on how the regulations have impacted the availability of medical devices, the development of innovative devices in the EU, costs and administrative burdens, as well as the benefits of the legislation. 

Now you have the possibility to submit comments. The deadline for participating in the evaluation is 21 March 2025. Access the survey

Read more about the call for feedback and the evaluation

Do you want to know more?

If you have any questions, please contact Plesner's Life Science team.