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European Commission Launches Targeted Consultation on MDR and IVDR

Date
March 1, 2025
Category

EU Regulations

Description

The European Commission (EC) has launched a targeted, public consultation to gather insights and feedback on the implementation and effectiveness of the Medical Devices Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR (EU) 2017/746). Although both the regulations are due to be evaluated in 2027, the Commission has decided to adjust this timeline to be completed in Q4 2025. Transitioning to the regulations has been wrought with delays, forcing numerous extensions over several years. The consultation aims to assess the effectiveness of these regulations, identify any challenges faced by stakeholders, and explore potential areas for improvement.

The MDR and IVDR are two crucial regulations governing the safety and performance of medical and in vitro diagnostic devices in the EU. They came into full force in May 2021 and May 2022, respectively, replacing the previous directives, the Medical Devices Directive (MDD) and theIn Vitro Diagnostic Devices Directive (IVDD).

The regulations ensure that medical devices and diagnostic tools sold within the EU meet stringent safety, health, and performance standards. These regulations also introduce more stringent requirements for clinical evaluations, post-market surveillance, and traceability to enhance patient safety and device performance.

Despite their comprehensive nature, the regulations have introduced significant changes to the regulatory landscape, with some stakeholders facing challenges related to the complexity of the new rules and the operational impact of the transition.

The consultation, in congruence with the October 2024 European Parliament’s joint resolution which cited the “urgent need to revise the Medical Devices Regulation” and directed the EC to provide an impact assessment on the regulations by Q1 2025, seeks to collect valuable input from a range of stakeholders, including medical device manufacturers, in vitro diagnostic device producers, notified bodies, healthcare professionals, regulators, and patient advocacy groups.

Gathering this feedback aims to:

  • Evaluate how effectively the regulations have been implemented, highlighting successes and identifying areas for adjustments.
  • Provide an opportunity for manufacturers and other stakeholders to express concerns about the regulatory burden, the cost of compliance, and the availability of qualified personnel and notified bodies.
  • Help the Commission understand whether the current rules continue to be adaptable, relevant, and practical as technology and healthcare needs evolve, and evaluate the overall impact on patient health.
  • Evaluate whether the current regulations encourage or hinder innovation, especially for smaller companies and startups.
  • Explore whether the EU’s regulatory framework is aligned with international standards and practices, ensuring that European manufacturers can remain competitive in the global market.

While the consultation covers a broad range of issues, there are several key themes under consideration:

  1. The regulations introduced more stringent requirements for clinical evidence, which some stakeholders have found challenging. The consultation will explore whether the current expectations are practical, particularly for high-risk devices.
  2. The new regulations placed more responsibility on notified bodies, the organizations responsible for assessing the conformity of devices before they can be marketed in the EU. However, notified bodies’ availability and capacity to handle the volume of devices needing certification has been a concern. The consultation will examine the effectiveness of the notified body system and potential improvements.
  3. One of the regulations’ key principles is stronger post-market surveillance, which aims to identify any device issues after entering the market. The consultation will assess whether the current systems for reporting incidents and monitoring device performance are sufficient.
  4. Implementing UDI systems has been a major step forward in ensuring the traceability of medical devices. The consultation will evaluate whether the UDI system is functioning as intended and whether any barriers to its implementation exist.
  5. Due to the resources required, small and medium-sized enterprises (SMEs) often face the greatest challenges in complying with the regulations. The consultation will seek to understand SMEs’ specific difficulties and how the regulatory framework can be adapted to support them.
  6. EU regulations must remain competitive on a global scale. The consultation will explore whether the EU’s regulatory environment aligns with international standards, particularly with the U.S. FDA, and whether regulatory convergence can simplify the process for global manufacturers.

The EC opened the consultation to stakeholders on December 12, 2024, allowing them to submit responses until March 21, 2025. In the first month, the feedback has been quite negative, citing systemic issues with implementation, high costs, and strong concerns over patient safety. After collecting and analyzing the complete feedback, the Commission will review the findings and potentially propose modifications or further actions to improve the regulations’ frameworks. The goal is to ensure that the regulations are rigorous enough to protect patient safety and flexible and supportive enough to encourage innovation.

Access the public consultation here: EU rules on medical devices and in vitro diagnostics – targeted evaluation