The European Commission has launched a new Call for Evidence as part of a targeted initiative to streamline the EU regulatory framework for medical devices—without conducting a full impact assessment. This step builds on ongoing evaluations of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Originally adopted in 2017, the MDR and IVDR were designed to ensure a high level of safety and public health while supporting innovation and aligning EU rules with international standards. The MDR became applicable in May 2021, followed by the IVDR in May 2022.
However, the implementation journey has proven complex. Key issues include:
- Increased regulatory demands that apply not only to new devices but also to legacy products.
- Limited capacity of notified bodies, slowing down conformity assessments.
- Insufficient preparedness among manufacturers, particularly small and medium-sized enterprises (SMEs).
These challenges have led to concerns over potential shortages and even the disappearance of critical medical devices from the market. As a response, the EU has extended the transitional provisions multiple times—most recently under Regulation (EU) 2024/1860, which now sets end dates of 2027, 2028, or 2029 depending on device type and risk classification.
Amid these issues, the Commission has been carrying out a targeted evaluation since 2024. In parallel, numerous stakeholders—including the European Parliament and Member States—have called for a simplified and future-proofed regulatory system.
What the Initiative Seeks to Address
This new Call for Evidence is distinct from previous efforts. While the earlier evaluation focused on identifying problems within the legal framework, the current initiative aims to gather stakeholder input on potential solutions.
The core problems being addressed include:
- Unpredictable certification timelines and inconsistent interpretation across EU Member States.
- Disproportionate requirements that do not always align with the risk posed by specific devices.
- Administrative burdens and high compliance costs, particularly for SMEs, which may discourage innovation or lead to market withdrawals.
If unaddressed, these issues are likely to have a continued negative impact on the availability of medical devices, patient care, and the overall competitiveness of the EU’s medical technology sector in a global context.
Objectives of the Targeted Revision
The initiative seeks to:
- Reduce administrative burdens while maintaining safety and performance standards.
- Enhance predictability and cost-efficiency of the regulatory process.
- Ensure timely availability of medical devices, particularly those critical to patient care.
- Support the EU’s innovation capacity and competitiveness in the global medical device market.
This Call for Evidence is an opportunity for stakeholders to shape a more resilient and responsive regulatory framework. All interested parties are encouraged to provide their input as the EU moves forward in refining its approach to medical device regulation.
To have your say in this initiative, please use the following link
Feedback period: 08 September 2025 – 06 October 2025 (midnight Brussels time
