The medical device transition has moved from a cliff edge to a staged runway — but the conditions attached to those extensions have already passed, and EUDAMED became mandatory this year.
Regulation (EU) 2017/745 has applied since 26 May 2021. Regulation (EU) 2023/607 then extended the transition for legacy devices, giving manufacturers breathing room — on strict conditions.
The deadlines
- 26 May 2026 — class III custom-made implantable devices.
- 31 December 2027 — class III and class IIb implantable devices (with exceptions).
- 31 December 2028 — class IIa, other class IIb, class I sterile or with a measuring function, and devices that were class I under the directives but now require notified body involvement.
The sell-off period was removed, so qualifying legacy devices placed on the market before the deadline can continue to be sold without a fixed stock-clearance cut-off.
The conditions you have already passed
These extensions were never automatic in practice. They required an MDR-compliant quality management system by 26 May 2024, a formal application to a notified body by 26 May 2024, and a signed agreement with that notified body by 26 September 2024. If those milestones were missed, the extension never applied to that device — a fact some manufacturers have yet to confront.
EUDAMED is now mandatory
This is the most immediate change. A Commission Decision of November 2025 declared the first four EUDAMED modules functional, which under Regulation (EU) 2024/1860 triggered a six-month transition. Since 28 May 2026, four modules are mandatory: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance.
Actor registration is the gateway — manufacturers, authorised representatives and importers must register to obtain a Single Registration Number, without which nothing else in the system can proceed. The remaining modules covering vigilance and clinical investigation are expected to follow.
Reform on the horizon
In December 2025 the Commission proposed a targeted revision to simplify the device rules, with feedback closing in March 2026. The proposal introduces criteria for breakthrough and orphan devices — the latter aimed at very low-volume, high-need products for rare disease and paediatric use — with priority and rolling review. It would also narrow the summary of safety and clinical performance obligation and, notably, allow the Person Responsible for Regulatory Compliance to act on a contractual basis rather than as a permanent employee. Timing remains uncertain; treat published expectations with caution.
How PQRA helps
PQRA supports classification and conformity assessment strategy, technical documentation, registration and vigilance across the EU MDR framework.
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