Conditional CE certificates: A new pathway for faster market access?
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
Over the past few years, the medical device industry has been navigating a complex regulatory landscape with the implementation of MDR 2017/745 and IVDR 2017/746. While these regulations have strengthened safety and performance standards, they have also created a bottleneck in the certification process, making it harder for manufacturers to bring their products to market efficiently.
With thousands of devices still awaiting certification, the backlog at Notified Bodies continues to grow, leading to significant delays and concerns over potential product shortages in the EU market.
What is Team NB’s proposal?
In response to this challenge, Team NB, the European association of Notified Bodies, has proposed conditional CE certificates as a strategic solution.
This regulatory tool, already foreseen under MDR/IVDR but seldom used, would allow devices to obtain CE marking under specific conditions, enabling earlier market access while maintaining rigorous post-market oversight.
How do conditional CE certificates work?
A device could be granted CE marking with restrictions such as:
More frequent post-market clinical surveillance, requiring ongoing safety and performance data collection
Shorter validity periods compared to the standard five-year certification, ensuring periodic regulatory review
Limited indications or restricted use until additional clinical evidence is gathered
Mandatory real-world data collection through dedicated registries
What are the benefits for manufacturers?
Faster market access: Devices could be introduced earlier while additional evidence is gathered post-market.
Greater regulatory flexibility: A progressive approval pathway could ease the burden on Notified Bodies.
Support for innovation: This approach could be particularly valuable for breakthrough technologies and unmet medical needs.
Addressing the MDR/IVDR backlog
One of the key drivers behind this proposal is the need to relieve regulatory congestion in the EU. With MDR/IVDR certification delays posing risks to market continuity, conditional CE certificates could offer a pragmatic pathway for manufacturers while maintaining high safety and compliance standards.
What’s next?
The proposal has sparked discussions among industry experts. While many see this as a practical approach to alleviating regulatory pressure, others stress the need for harmonized application across Notified Bodies to ensure fairness and consistency.
For now, it remains to be seen whether this approach will gain traction at a broader level. In the meantime, staying informed and strategically planning your certification pathway is crucial.
Want to learn more?
If your company is navigating the complexities of MDR/IVDR compliance, we can support you in optimizing your certification strategy and accelerating your market access.
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