Updated July 2026. Scope: EU MDR 2017/745, legacy medical devices, the extended transition, and EUDAMED. For the definition on its own, see the legacy medical device glossary entry.
Key takeaways
- A legacy medical device is one still on the market under an old-directive certificate during the MDR transition, not a device that has completed MDR conformity assessment.
- Regulation (EU) 2023/607 extended the transition deadlines to 31 December 2027 or 31 December 2028 depending on class, but only when specific conditions are met.
- The extension is not a compliance holiday. MDR rules on post-market surveillance, vigilance, market surveillance, and registration already apply to legacy devices.
- Registration obligations run through EUDAMED. Legacy devices and their economic operators are in scope for the EUDAMED registration that is becoming mandatory.
What a legacy medical device is
“Legacy device” is a defined transition concept, clarified by MDCG guidance (MDCG 2021-25). In line with MDR Article 120, a legacy device is a device placed on the market after the MDR date of application (26 May 2021) on the basis of a valid certificate issued under the old directives, Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD), before 26 May 2021, or a Directive 93/42/EEC Class I device that now requires notified-body involvement under the MDR. These devices may continue to be placed on the market during the transition window without having completed MDR conformity assessment.
The label matters: a legacy device is neither a fully MDR-certified device nor an off-market device. It is a device lawfully bridging the gap, under conditions.
The extended transition deadlines
Regulation (EU) 2023/607 amended MDR Article 120 and pushed the transition deadlines out, staggered by risk class:
| Device class | Extended deadline |
|---|---|
| Class III and Class IIb implantable devices (with limited exceptions) | 31 December 2027 |
| Class IIb (other), Class IIa, Class Im/Is/Ir, and Class I devices requiring notified-body involvement | 31 December 2028 |
These dates replace the earlier 26 May 2024 cliff. They apply to devices that meet the conditions below. Devices that do not meet the conditions do not get the extended timeline.
The conditions for the extension
The extended transition is conditional, under MDR Article 120 as amended. In outline, a legacy device keeps the benefit of the extended deadline only if:
- the device continues to comply with the applicable old directive (MDD or AIMDD);
- there is no significant change in the design or intended purpose of the device;
- the device does not present an unacceptable risk to health or safety;
- by 26 May 2024, the manufacturer had lodged a formal application for MDR conformity assessment with a notified body; and
- by 26 September 2024, the manufacturer and the notified body had signed a written agreement for that assessment.
If a manufacturer missed those application and agreement milestones, the device is outside the extended transition. This is a common and expensive misread: the later 2027 and 2028 dates only help devices whose MDR process was already in motion on the earlier milestones.
The extension is not a compliance holiday
The most costly misunderstanding is treating a legacy device as exempt from the MDR until its deadline. It is not. Under MDR Article 120, MDR requirements on post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices already apply to legacy devices, in place of the corresponding old-directive obligations.
In practice that means a legacy device needs:
- an MDR-grade post-market surveillance system and the associated reporting;
- MDR vigilance and incident reporting;
- registration of the manufacturer and other economic operators, and of the devices themselves.
Oversight of the old-directive certificate stays with the notified body that issued it during the transition, while these MDR obligations run in parallel.
EUDAMED and registration
Registration under the MDR runs through EUDAMED, the European database on medical devices. Legacy devices and their economic operators are within the scope of EUDAMED registration, and the registration modules are moving from voluntary to mandatory use. A legacy-device manufacturer should confirm its actor registration and its device and certificate data are captured, rather than waiting for full MDR certification to engage with the database. For the timeline and module detail, see the EUDAMED guide below.
Frequently asked questions
What is a legacy medical device under the MDR?
A device placed on the market during the MDR transition on the basis of a valid MDD (93/42/EEC) or AIMDD (90/385/EEC) certificate issued before 26 May 2021, or an MDD Class I device that now needs notified-body involvement under the MDR. It is defined by the transition, not by having completed MDR conformity assessment.
What are the new transition deadlines?
Regulation (EU) 2023/607 set 31 December 2027 for Class III and Class IIb implantable devices, and 31 December 2028 for most other classes, provided the conditions in the amended MDR Article 120 are met.
Does every old-certificate device automatically get the extension?
No. The extended deadline is conditional. Among other things, the manufacturer had to have lodged a formal MDR application by 26 May 2024 and signed a written agreement with a notified body by 26 September 2024. Devices that missed those milestones are outside the extended transition.
Do MDR rules apply to legacy devices during the transition?
Yes. MDR requirements on post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices apply to legacy devices now, in place of the corresponding old-directive requirements.
Do legacy devices need to be in EUDAMED?
Registration under the MDR runs through EUDAMED, and legacy devices and their economic operators are in scope. As the EUDAMED modules become mandatory, legacy-device manufacturers should ensure their actor, device, and certificate data are registered.
Related guides and services
- Regulatory Affairs support from CENIT Consulting: managing the MDR transition for legacy devices, the Article 120 conditions, and the post-market and registration obligations that apply now.
- For the database timeline, see the guide on EUDAMED becoming mandatory in 2026, and for the definition see the legacy medical device glossary entry.
This article is for general information only and is not legal or regulatory advice. Teams remain responsible for regulatory decisions and staying current with applicable regulations and guidance.
Talk to CENIT Consulting about your legacy-device transition plan: book a 30-minute consult.