Public Consultation on the Medical Devices Regulations

On December 12, the European Commission (EC) launched a Public Consultation to gather feedback from stakeholders on the implementation of the medical devices regulations, namely Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (collectively, the "Regulations").

Objective of the Public Consultation

The primary goal of this initiative is to identify the challenges faced by the industry participants, health care providers and other stakeholders in the implementation of the Regulations. It aims to uncover the reasons behind these difficulties and understanding the reasons for the repeated extensions of the transitional periods that had to be approved.

Key issues identified

Taking into consideration the experience with the implementation of the Regulations, it is important to highlight that the practical application of the standards set out in the Regulations has highlighted several complexities:

• Regulatory burden: the requirements introduced by the Regulations have required the reclassification and recertification of many medical devices and in vitro diagnostic medical devices, significantly increasing the workload of Notified Bodies.
• Extended processes: length reclassification and recertifications, have become more time-consuming, leading to extended transition periods in order to avoid product discontinuation and market shortages.
• Impact on SMEs: the requirements have a particular impact on small and medium-sized enterprises (SMEs), which struggle with lengthy processes and significant costs involved.

Call for Stakeholder participation

Given these challenges, the European Commission seeks to identify the issues that the industry representatives, patients, healthcare professionals and other stakeholders perceive as needing improvement.

The public consultation began on December 12, 2024, and will continue open until March 21, 2025 (ending at midnight, Brussels time). It is open to all interested parties and can be conducted on the European Commission's website, without any specific formalities. 

Next Steps

After March 21, 2025, the European Commission aims to conduct further actions to ensure the analysis is as complete as possible in order to overcome the challenges that have been experienced. The objective is to include a set of specific consultation activities tailored to specific stakeholder groups, with a view to further deepen the contributions and comments and prepare the solutions to overcome the difficulties faced.

Why participate

We believe that the initiative taken by the Commission is important opportunity to shape the future of medical device regulations, and we encourage the active participation of all interested parties to contribute with your insights. Any contributions may represent a step towards ensuring that existing Regulations are not only applied, but also adapted to the requirements of the sectors effectively and efficiently.