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The clock is ticking for medical device manufacturers operating in the European Union as we move toward 2026 and 2027. Although the MDR transition deadlines may have once felt distant, the end of the transition period is now rapidly approaching, bringing with it serious risks for companies that have not yet fully prepared.
Manufacturers who wait too long to engage with Notified Bodies or to finalize their compliance strategy may find themselves in a severe bottleneck at the exact moment when regulatory workload across the industry peaks, resulting in disruption of supply chains, delayed certifications, and impact on patient access to essential devices.
If you're a manufacturer still relying on legacy certificates from the old directives, now is the time to act... before it's too late.
EU MDR: The End of the Transition Period Is Near — Manufacturers Must Act Now to Avoid a Bottleneck in 2027
The MDR, fully applicable since May 2021, introduced stricter requirements for clinical evidence, post-market surveillance, and quality management systems (QMS). To avoid device shortages, the EU extended transition periods for legacy devices (those certified under the MDD or AIMDD) through Regulation (EU) 2023/607. However, these extensions come with strict conditions, and the clock is ticking.
Here's a breakdown of the key end dates for placing legacy devices on the market or putting them into service:
With the current date being December 2025, many manufacturers who met the 2024 deadlines are now in the thick of conformity assessments. But Notified Bodies — already stretched thin — are facing a surge in applications as the 2027 and 2028 deadlines loom. This sets the stage for bottlenecks in 2026-2027, where delays in reviews could lead to certification backlogs, supply disruptions, and increased costs.
A Perfect Storm Is Forming for 2026–2027
Why 2026 Will Be One of the Most Demanding Regulatory Years
Several high-impact obligations converge in 2026:
- Mandatory use of EUDAMED from May 2026 onward
- Peak MDR transition activity, including technical file updates and Notified Body submissions
For many manufacturers, 2026 will require more regulatory resources than any other year since the MDR entered into force.
What Manufacturers Should Do Now
To avoid being caught in the 2026–2027 bottleneck, proactive action is essential.
Conclusion: Urgency Is Now a Necessity
The final MDR transition phase will test more than regulatory compliance; it will test operational resilience across the entire medical device industry.
2026–2027 will be the most demanding years yet, and those who delay may face certification gaps, market disruption, or withdrawal of devices from the EU. Don't wait for the bottleneck: act now to secure your place in the market.
Acting now is no longer optional: it is essential.
Our experts support manufacturers across the full MDR and IVDR lifecycle, from transition strategy to Notified Body submissions and EUDAMED implementation. Working together now can help relieve pressure on internal teams and secure continued access to the EU market.
Do not hesitate to get in touch.
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