A timely step towards a more efficient regulatory system
Brussels, 22 June 2026 – AESGP, together with six other associations, developed a joint position paper highlighting how the European Commission’s proposed revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) can deliver a more efficient, risk-based, and proportionate regulatory framework for medical technologies in Europe. The paper focuses on the proposed improvements to life cycle oversight and reporting requirements, demonstrating how simplification can go hand in hand with maintaining high levels of patient safety.
The MDR and IVDR marked an important step forward in strengthening Europe’s regulatory framework for medical technologies. However, their implementation has also brought increased complexity, administrative burden, and higher costs for manufacturers, affecting predictability and, in some cases, the availability of medical technologies in Europe.
The European Commission’s proposal offers an important opportunity to address these issues while preserving the core principles of the current system.
From administrative burden to meaningful oversight
The joint paper shows that the proposed revision enables a shift towards a more targeted and risk-based approach to regulation by:
- Focusing oversight on higher-risk products and real safety concerns
- Replacing duplicative administrative processes with more efficient, risk-based mechanisms
- Allowing notified bodies and authorities to use their resources where they are most impactful
By reducing routine and low-value tasks, the system can better detect safety signals earlier and respond more effectively when issues arise.
Maintaining strong safeguards for patient safety
Simplification does not mean lowering standards. The proposed revision fully preserves the life cycle approach introduced by MDR and IVDR:
- Manufacturers remain responsible for safety and performance throughout the entire product lifecycle
- Notified Bodies continue to provide independent conformity assessment and ongoing surveillance
- Competent authorities retain their roles in market oversight, vigilance, and enforcement
In addition, tools such as EUDAMED and enhanced coordination mechanisms will continue to support transparency, traceability, and faster intervention across the EU.
Supporting innovation and access in Europe
A more proportionate and targeted regulatory system is essential for both patient safety and the long-term resilience of Europe’s healthcare ecosystem.
By reducing unnecessary administrative burden and improving predictability, the revision can help:
- Strengthen the competitiveness of the European medical technology sector
- Support innovation and investment (evidence is showing economic stalling in the EU)
- Ensure continued availability of safe and effective devices for patients and healthcare systems
Simplification, when designed carefully, strengthens the system by ensuring that attention and resources are focused where they matter most.