EUDAMED: the 28 November deadline for devices already on the market
Regulatory briefing · 3 November 2026
EUDAMED
Devices already on the EU and Northern Ireland markets, and still being placed on them, need a EUDAMED record by 28 November 2026. A valid certificate does not exempt them.
Jonathan Phillips, Lead Auditor. 3 November 2026.
EUDAMED is the EU database for medical devices and IVDs.
Four of its modules have been mandatory since 28 May 2026. They cover actor registration, UDI and device registration, notified bodies and certificates, and market surveillance.
New devices must now be registered before they are placed on the market. Devices already on the market were given until 28 November 2026.
This briefing sets out who that deadline covers, what is outside it, and what comes next.
In short: if a device was on the EU or Northern Ireland market before 28 May 2026 and you are still placing it on the market, it needs a EUDAMED record by 28 November. Work to Friday 27 November.
At a glance
The deadline is 28 November 2026 on the Commission's timeline. It applies under the MDR and the IVDR.
It covers devices placed on the market before 28 May 2026 that are still being placed on the market. This includes legacy devices on Directive certificates or declarations.
A valid certificate does not exempt a device. This includes MDD and AIMDD certificates extended to 2027 or 2028, and IVDD certificates extended to 2027.
Devices no longer placed on the market from 28 May 2026 are outside the deadline, for now.
Custom-made devices are outside it under the MDR.
A legacy device does not need its own record if the same device is already registered as an MDR or IVDR device.
Northern Ireland is in. EUDAMED replaced MHRA registration for the NI market from 28 May 2026. Custom-made devices stay with the MHRA.
Notified bodies have until 28 May 2027 to enter MDR and IVDR certificates issued before 28 May 2026.
Who the deadline covers MDR Article 123(3)(e); IVDR Article 113(3)(fa)
The obligation is on the manufacturer. The manufacturer must enter the device registration information in EUDAMED. Under the MDR this is the information in Article 29. Under the IVDR it is Article 26.
It applies to two groups:
MDR/IVDR: devices that went through conformity assessment under the MDR or IVDR.
Legacy: devices placed on the market under MDR Article 120(3), (3a) or (3b), or IVDR Article 110(3), (3a) or (3b). These rely on a Directive certificate or declaration.
There is one condition. The device must also be placed on the market from 28 May 2026. If you are still placing units on the market, it is in.
A legacy device does not need its own record if the same device is already registered as an MDR or IVDR device. The Commission’s Q&A says the same device means the same identification, such as the UDI-DI, catalogue number or trade name. A redesigned replacement with a new UDI-DI does not count.
A valid certificate does not exempt you MDR Article 120; IVDR Article 110
Many legacy devices rely on Directive certificates extended under MDR Article 120 or IVDR Article 110.
Under the MDR, an MDD or AIMDD certificate can run to 31 December 2027 for class III and most class IIb implantable devices. For other class IIb devices, class IIa, and class I sterile or measuring devices, it can run to 31 December 2028. In both cases the Article 120 conditions must be met. Under the IVDR, IVDD certificates run to 31 December 2027.
The extension keeps the device on the market. It does not remove the EUDAMED obligation. Legacy devices are named in it.
What is outside the deadline
Discontinued: if you stopped placing a device on the market before 28 May 2026, the deadline does not apply to it. That may change once the vigilance module is mandatory. A device may then need registering if a vigilance report or PSUR is required.
Excluded: custom-made devices, under the MDR.
Registered: legacy devices where the same device is already registered as an MDR or IVDR device. See above.
Triage the portfolio before you start uploading. List every device and mark which are still being placed on the market. For some manufacturers this takes out a large part of the job.
27 or 28 November?
The notice that the four modules are functional is Commission Decision (EU) 2025/2371. It was published in the Official Journal on 27 November 2025.
The MDR deadline is 12 months from that publication. The IVDR deadline is 6 months from the date the modules became mandatory. The Commission's timeline gives 28 November 2026 for both.
Some summaries give 27 November. For the MDR, that reading can be defended under the EU rules on counting time periods.
28 November 2026 is a Saturday. Work to Friday 27 November.
Northern Ireland Windsor Framework
The MDR and IVDR apply in Northern Ireland under the Windsor Framework. That includes the changes made by Regulation (EU) 2024/1860.
The MHRA's guidance says that since 28 May 2026, devices other than custom-made devices must be registered in EUDAMED before they are placed on the Northern Ireland market. MHRA registration is no longer required for them.
So the 28 November deadline covers devices on the Northern Ireland market as well.
Custom-made devices are not registered in EUDAMED’s device module. They stay with the MHRA and must be registered within 28 days of being made available on the Northern Ireland market.
The MHRA guidance does not say what happens to Northern Ireland registrations made with the MHRA before 28 May 2026. If you rely on one, check it.
What comes next
Certificates: notified bodies must enter certificate information by 28 May 2027 on the Commission's timeline. MDCG 2026-4 rev.1 gives 27 May 2027.
Summaries: MDCG 2026-4 rev.1 says the upload of SS(C)Ps and SSPs is moving from the notified body to the manufacturer. MDR Article 32(1) still names the notified body, and MDCG 2019-9 has not yet been revised. New EUDAMED functionality is planned for December 2026. For MDR and IVDR devices placed on the market before mandatory use, it says manufacturers should upload no later than 27 March 2027. This is guidance, not a legal deadline. Under MDR Article 32(1), SS(C)Ps are needed for implantable and class III devices, other than custom-made and investigational devices. Under IVDR Article 29(1), SSPs are needed for class C and D IVDs, other than devices for performance studies. Legacy devices do not need them.
Vigilance: the vigilance module is not yet mandatory and no date has been set. The Commission's November 2025 roadmap indicated Q2 2027, subject to audit. It expected the notice in Q4 2026, and that notice has not been published. Once it is mandatory, submitting a PSUR, or reporting a serious incident, a field safety corrective action or a trend, through EUDAMED means the device must be registered at that point. Devices placed on the market under the Directives before 26 May 2021 (MDR) or 26 May 2022 (IVDR) are excepted. On the Commission's Q&A and MDR Article 120(3d) and (4) and IVDR Article 110(3d) and (4), that exception does not cover legacy devices placed on the market under MDR Article 120(3), (3a) or (3b), or IVDR Article 110(3), (3a) or (3b).
What to do now
List every device you place on the EU or Northern Ireland market.
Mark which are still being placed on the market from 28 May 2026.
For each legacy device, check whether the same device is already registered as an MDR or IVDR device.
Check which devices already have a EUDAMED record.
Register the rest by Friday 27 November.
Check your actor registration and SRN are in place. Device registration depends on them. If you need an Authorised Representative, it must be registered too.
Put the next dates in the diary: 27 March 2027 for SS(C)P and SSP uploads where they apply, and 28 May 2027 for certificates.
What is opinion, and what is not verified
Working to 27 November is my advice, not a legal requirement.
That the deadline covers Northern Ireland follows from the MDR and IVDR applying there. The MHRA guidance does not mention 28 November.
The Commission's Q&A has not been formally endorsed by the Commission. MDCG 2026-4 rev.1 says it does not reflect the Commission's official position.
The vigilance roadmap date is indicative and subject to audit.
If you would like help, please contact us. We can:
triage your portfolio against the 28 November deadline
register your devices in EUDAMED
check legacy devices against their MDR or IVDR registrations
set out your Northern Ireland position
This briefing is for general information and is not legal advice.
Sources
Regulation (EU) 2024/1860, 13 June 2024, OJ L, 9 July 2024. Regulation (EU) 2017/745 (MDR), Articles 29, 31, 32, 120 and 123(3), consolidated text. Regulation (EU) 2017/746 (IVDR), Articles 26, 28, 29, 110 and 113(3), consolidated text. Commission Decision (EU) 2025/2371, 26 November 2025, OJ L, 27 November 2025. European Commission, EUDAMED overview, transition timelines and roadmap. European Commission, Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed, current version on the Commission website. MDCG 2026-4 rev.1, Management of SS(C)P in EUDAMED after mandatory use, October 2026. Regulation (EEC, Euratom) No 1182/71, Articles 3 and 5. Windsor Framework, Articles 5(4) and 13(3) and Annex 2. MHRA, Register medical devices to place on the market, updated 16 October 2026.
Jonathan Phillips is Managing Director of B.S. Partnership Ltd, Cardiff, and EU-UK Authorised Representative Ltd, Belfast. This page reflects the legislative position as at 3 November 2026.