EU / Medical Devices — MDR Transition
Class III and most implantable Class IIb legacy devices still on old MDD/AIMDD certificates lose that basis on 31 December 2027. Every other legacy device class follows on 31 December 2028. Custom-made Class III devices had no extension at all — their deadline, 26 May 2026, has already passed.
Last updated 24 August 2026
The extended MDR transition timeline was never a single cut-off. Class III devices and most implantable Class IIb devices — the highest-risk categories — must hold MDR certification by 31 December 2027, at which point their old MDD or AIMDD certificate stops being valid. Every other legacy class still on the market under transition provisions — non-implantable Class IIb, Class IIa, Class Is/Im, and any device up-classified under MDR's new rules — has until 31 December 2028.
Source: morulaa.com's EU MDR Compliance Timeline 2024–2028, corroborated by elexes.com and lso-inc.com MDR extension coverage (WebSearch/WebFetch, 2026-08-23).
Reaching either 2027 or 2028 date on the extended timeline required two earlier milestones. A Quality Management System had to be in place and a formal Notified Body application submitted by 26 May 2024. A signed Notified Body agreement then had to follow by 26 September 2024. A manufacturer who missed either milestone generally cannot rely on the extension at all — their MDD/AIMDD certificate may already be invalid, regardless of device class.
Custom-made Class III devices never had access to the longer extensions in the first place. Their own deadline, 26 May 2026, has already passed as of this page's last update.
This is a distinct compliance-risk hook from EUDAMED registration (27 November 2026), which covers database entry, not certificate validity. A device can be correctly registered in EUDAMED and still fall off the EU market on 31 December 2027 if the underlying certificate itself has lapsed. Both deadlines apply independently to the same legacy-device population.
Two hard dates. Class III devices and most implantable Class IIb devices still on old MDD/AIMDD certificates must hold MDR certification by 31 December 2027 — after that, the old certificate no longer works. All remaining legacy devices (non-implantable Class IIb, Class IIa, Class Is/Im, and up-classified Class I devices) follow by 31 December 2028. A narrower deadline of 26 May 2026 already applied to custom-made Class III devices, which cannot access either extension.
EUDAMED (27 November 2026) is a database registration requirement — actor, device, UDI and certificate data must be entered into the EU's database. This deadline is about certificate validity itself: whether the underlying MDD/AIMDD certificate a legacy device relies on still legally permits it on the market at all. A device can in principle be EUDAMED-registered and still fall off the market on 31 December 2027 if its certificate lapses.
No. Access to the 2027/2028 extensions required two earlier milestones: a Quality Management System in place and a Notified Body application submitted by 26 May 2024, and a signed Notified Body agreement in place by 26 September 2024. Manufacturers who missed either milestone generally cannot rely on the extension and their MDD/AIMDD certificates may already have lapsed.
The old MDD/AIMDD certificate stops being valid. Without a transitioned MDR certificate in place by that date, a Class III or implantable Class IIb device loses its legal basis to stay on the EU market — the same practical effect as any other lapsed conformity certificate.
Tracking which legacy SKUs qualify for the extension, which already missed a 2024 milestone, and which class deadline applies to each is a portfolio-wide audit, not a single form. We scope the legacy-device gap across your product range, coordinate with your Notified Body on transition timing, and manage the certification programme end to end.
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