Unlocking MedTech Innovation in Europe: A Call for Smarter, Faster Certification
In an evolving healthcare landscape, timely access to innovative medical technologies is more critical than ever. However, high certification costs and unpredictable regulatory pathways are slowing down progress in Europe. With the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) now fully in effect, the need for a more efficient and innovation-friendly framework has become urgent.
MedTech Europe, the leading trade association for the medical device industry in Europe, has outlined four priority measures to address these challenges and ensure Europe remains competitive as a launch market for new medical technologies. At the same time, the European Commission has presented its own regulatory improvement agenda for 2025.
MedTech Europe’s Four Urgent Priorities
To facilitate faster market access and sustain innovation, MedTech Europe recommends the following reforms:
1. Faster Initial Product Approvals
The current approval process is marked by delays and administrative burdens. To accelerate time to market, the industry is calling for binding review timelines, greater transparency on approval durations and costs, structured early dialogue with Notified Bodies, and a reduction in redundant steps.
2. Lifetime Risk-Based Certification
Routine recertification cycles are straining Notified Bodies and threatening supply continuity. The proposal? Extend the validity of existing certificates from 5 to 10 years, and shift to a risk-based reassessment model that focuses on actual safety concerns or significant changes—rather than automatic re-certification.
3. A Fast-Track Pathway for Breakthrough Devices
Breakthrough innovations deserve accelerated pathways. MedTech Europe advocates for a 120-day review track for eligible technologies, supported by early collaboration and real-world evidence. A pilot program in 2025 could pave the way for long-term integration into the EU regulatory framework.
4. Smarter Change Notification Procedures
To avoid unnecessary delays, the process for notifying changes to certified devices should differentiate between major and minor modifications. Only impactful changes should require Notified Body involvement, allowing manufacturers to maintain and improve devices efficiently.
The European Commission’s 2025 Vision
Alongside the industry-led proposals, the European Commission is also taking action. In a recent address, the Commissioner for Health shared key initiatives planned for 2025, including:
- Simplifying conformity assessments by capping timelines at 12 months and lowering certification costs.
- Broadening the use of electronic instructions for use (eIFU) to enhance accessibility and reduce environmental impact.
- Launching an expert panel for breakthrough and orphan devices to speed up access to critical innovations.
- Expanding the list of well-established technologies (WET) to simplify approval pathways for low-risk products.
- Issuing an Implementing Act for Notified Bodies to harmonize performance expectations and increase transparency across the EU.
What This Means for Manufacturers
For medical device companies navigating the EU market, these developments represent a significant shift. Faster approvals, reduced bureaucracy, and a more risk-based approach could make Europe more attractive for innovation once again.
At Certification Experts, we stay closely aligned with these evolving regulations. As your partner in EU MDR and IVDR compliance, we help you anticipate changes, streamline your certification journey, and bring your innovations to the European market—faster, safer, and more efficiently.
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