The EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were designed to enhance patient safety and device quality. 

However, by 2024, systemic challenges had reached a breaking point, leading to urgent calls for reforms to ensure the regulations achieve their intended goals without compromising the industry’s ability to innovate.

The European Parliament’s Resolution

In October 2024, the European Parliament responded to these escalating concerns by adopting a joint motion for a resolution that acknowledged the urgency of addressing the following issues:

• Certification Bottlenecks: Many devices have faced delays or have not been certified at all, which has been especially difficult for small and medium-sized businesses (SMEs) with limited resources.
• Notified Body Capacity Issues: A shortage of accredited notified bodies has caused delays and made certification timelines unpredictable.  
• Inconsistent Processes: Variability in procedures across notified bodies has added complexity and uncertainty for manufacturers.
• Bureaucratic Burdens: Strict and unclear documentation requirements have further delayed the market entry of life-saving devices.

The resolution urged the European Commission to propose actionable reforms by early 2025 to streamline these processes and restore confidence in the regulatory framework.

MedTech Europe’s Support

MedTech Europe, representing the medical technology industry, welcomed the European Parliament’s recognition of these issues and endorsed the resolution, reaffirming its concerns about the adverse effects on SMEs, which form the backbone of medical innovation. MedTech Europe’s key recommendations included:

• Reducing unnecessary bureaucratic requirements to accelerate device certification.
• Enhancing notified body capacity and aligning evaluation processes across the EU.
• Establishing a single, accountable governance framework specific to the medical technology sector.

Discussions at the EPSCO Council

In December 2024, the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) gathered to discuss reforms. Member states acknowledged the systemic issues and debated strategies to address the regulatory bottlenecks. The council’s discussions highlighted:

• The need to improve notified body capacity and consistency in evaluations.
• The importance of supporting SMEs to sustain innovation and prevent market disruptions.
• Proposals for streamlined governance and reduced bureaucratic complexity.

Based on these developments, it is clear that policymakers, industry leaders, and healthcare stakeholders are united in their commitment to create a regulatory framework that supports innovation, ensures patient safety, and facilitates timely access to life-saving devices.