CE Marked Devices in the UK
Can CE marked medical devices still be sold in the UK?
Yes, CE marked medical devices can still be sold in the UK. In Great Britain (England, Wales and Scotland) they are accepted under transitional provisions that currently end on 30 June 2028 or 30 June 2030, depending on the device and the EU law it meets. In Northern Ireland CE marking is still the required mark. On 21 October 2026 the government said it will legislate to recognise EU MDR and EU IVDR CE marked devices in GB indefinitely. Until that law is made, the current end dates still apply.
Approach: I searched MHRA's medical device guidance and the UK Medical Devices Regulations 2002 (SI 2002/618) as revised. I also read the GOV.UK government response to the 2026 consultation on indefinite CE recognition.
Great Britain: the law today
Regulation 1ZA of the UK MDR 2002 (inserted by SI 2023/627) sets the end dates for the CE acceptance provisions [1]:
- Regulations 19B and 30A stop having effect at 23:59 on 30 June 2028.
- Regulations 19C, 44ZA and 44ZB stop having effect at 23:59 on 30 June 2030.
How MHRA applies those dates [2]:
| CE basis | Can be placed on the GB market until |
|---|---|
| General devices under EU MDD or AIMDD, with a valid declaration and CE marking | 30 June 2028, or earlier if the certificate expires first |
| IVDs under EU IVDD | 30 June 2030, or earlier if the certificate expires first |
| General devices (including custom-made) under EU MDR, and IVDs under EU IVDR | 30 June 2030 |
| Class I devices self-declared against EU MDR | 30 June 2030 |
| Class I devices self-declared against MDD before 26 May 2021 that need a notified body under EU MDR (upclassified devices, reusable surgical instruments) | 30 June 2028 |
| Class Is/Im (sterile or measuring) with a valid MDD certificate | 30 June 2028 |
Exclusions and conditions:
- No longer accepted: custom-made devices compliant with EU MDD or AIMDD.
- No expired certificates: you cannot rely on an expired certificate unless the EU has deemed it valid [2].
- Extended EU certificates: certificates extended under EU MDR Article 120 or IVDR Article 110 can be used for both the GB and NI markets. Any mandatory third-party assessment for the CE mark must be done by an EU notified body.
- Market surveillance: the enforcement and market surveillance powers that apply to UKCA marking also apply to CE marked devices in GB [3].
Great Britain: the decision published 21 October 2026
The government response (on the consultation page) sets out what the government intends to do:
- EU MDR and IVDR devices: indefinite recognition of all CE marked devices certified under EU MDR and EU IVDR. The requirements in regulations 19C, 30A and 44ZB stay in place.
- EU MDD devices: acceptance lines up with the EU transition deadline, currently 31 December 2028. MDD devices placed compliantly on the EU or GB market before the EU transition ends could stay on the GB market, mirroring the EU approach.
- Rejected: a separate reliance route for devices classified higher in GB than in the EU.
- Timing: the changes need Parliament's approval. They are to be made before 30 June 2028, the earliest current deadline.
Until that legislation is made, the dates in regulation 1ZA remain the law. MHRA's guidance says the transitional arrangements stay in place while the consultation is being considered [2].
Obligations that stay either way: manufacturers of CE marked devices sold in GB must still:
- appoint a UK responsible person if they are based outside the UK;
- register their devices with MHRA;
- meet the GB post-market surveillance requirements in force since June 2025;
- make technical documentation and certificates available in English.
Northern Ireland
Under the Windsor Framework, the EU MDR and IVDR apply in Northern Ireland [4]. A CE marking is required there, and devices carrying only a UKCA mark cannot be sold in NI. Dual-marked devices (CE, or CE plus UKNI, together with UKCA) are accepted. "CE UKNI" (used where a UK notified body did the assessment) is valid in NI but not in the EU [5].
A GB-based manufacturer supplying NI must appoint a sole authorised representative based in the EU or NI [6].
Is there still a deadline for CE marks in Great Britain?
Yes, for now. In Great Britain, CE marked devices are still accepted only until 30 June 2028 or 30 June 2030, depending on the device and the EU law it meets. On 21 October 2026 the government said it intends to remove the deadline for EU MDR and EU IVDR devices, but that change has not been made into law yet.
Approach: I checked the UK Medical Devices Regulations 2002 (SI 2002/618, as revised) and MHRA's medical device guidance. I also reread the GOV.UK government response published on 21 October 2026.
The law today
Regulation 1ZA of the UK MDR 2002, substituted by SI 2023/627, sets the end dates. Regulations 19B and 30A stop having effect at 23:59 on 30 June 2028. Regulations 19C, 44ZA and 44ZB stop having effect at 23:59 on 30 June 2030 [1]. MHRA applies these dates as follows [2]:
| CE basis | Deadline to place on the GB market |
|---|---|
| EU MDD / AIMDD general devices | Certificate expiry or 30 June 2028, whichever comes first |
| EU IVDD IVDs | Certificate expiry or 30 June 2030, whichever comes first |
| EU MDR devices (including custom-made) and EU IVDR IVDs | 30 June 2030 |
| Class I self-declared under EU MDR | 30 June 2030 |
| Class I self-declared under MDD before 26 May 2021 that need a notified body under EU MDR (upclassified devices, reusable surgical instruments) | 30 June 2028 |
| Class Is/Im with a valid MDD certificate | 30 June 2028 |
MHRA's guidance says these arrangements stay in place while the consultation is considered [2].
What the government now intends
The government response of 21 October 2026 sets out three points (pages 18 and 21):
- EU MDR and IVDR devices: the government intends to recognise all CE marked devices certified under EU MDR and EU IVDR indefinitely, keeping the requirements in regulations 19C, 30A and 44ZB. For these devices, the deadline would go.
- EU MDD devices: there would still be a deadline. It would move to the end of the EU transition period, currently 31 December 2028. MDD devices placed compliantly on the EU or GB market before then could stay on the GB market.
- Timing: MHRA will bring in the legislation, subject to Parliament's approval. It is to be made before 30 June 2028, the earliest current deadline.
The response does not say what happens to the 30 June 2030 date for IVDD devices.
In practice: until the amending regulations are made, the 2028 and 2030 dates in regulation 1ZA still apply. Once they are made, EU MDR and IVDR CE marked devices would have no GB end date, and MDD devices would have a deadline that follows the EU's.
What about IVDs and Northern Ireland?
For IVDs, Great Britain still accepts CE marked devices until 30 June 2030 (or earlier, when the certificate expires). For Northern Ireland, CE marking under the EU IVDR is the requirement itself, so there is no end date to plan around. The government's 21 October 2026 plan would remove the GB deadline for IVDR devices, but the law has not changed yet.
Approach: I searched MHRA's medical device guidance (the IVD registration, Northern Ireland and CE-acceptance timeline pages) and regulations 44ZA and 44ZB of the UK Medical Devices Regulations 2002 (SI 2002/618, as revised).
IVDs in Great Britain
What the law says. Two regulations let a CE marked IVD meet the UK rules:
- Regulation 44ZA (IVDD devices): the device must have an EU IVDD declaration of conformity drawn up before 26 May 2022. Any notified body certificate must still be valid under IVDR Article 110(2) [7].
- Regulation 44ZB (IVDR devices): any notified body certificate must not have expired or been withdrawn [8].
Both regulations stop having effect at 23:59 on 30 June 2030 under regulation 1ZA, as covered in my earlier answers.
How MHRA applies it [9]:
- CE marked IVDs that meet EU IVDD or EU IVDR can be placed on the GB market until 30 June 2030 or until the certificate expires, whichever is sooner.
- IVDD self-declared general IVDs only qualify if they are upclassified, meaning the IVDR would now require a notified body for them. This is also the condition in regulation 44ZA(3A) [7].
- Expired certificates cannot be relied on unless the EU has deemed them valid.
- IVDD certificates extended under IVDR Article 110 are valid in GB for as long as GB accepts IVDD CE marked devices. MHRA encourages manufacturers to update their entries in its Device Online Registration System (DORS).
Practical cut-off dates. Because an IVDD device can only be relied on while its EU validity lasts, the EU's extended dates act as the real cut-off in GB. MHRA's timeline infographic [10] and the IVD registration guidance [11] give these dates:
| IVDD basis | IVDR class | IVDD basis valid until | After that |
|---|---|---|---|
| Annex II List A, List B, self-test (IVDD EC certificate) | D / C / B | 31 Dec 2027 | IVDR CE certificate, until 30 Jun 2030 |
| General IVD, self-declared, upclassified to D | D | 31 Dec 2027 | IVDR CE certificate |
| General IVD, self-declared, upclassified to C | C | 31 Dec 2028 | IVDR CE certificate |
| General IVD, self-declared, upclassified to B, or Class A sterile | B / A sterile | 31 Dec 2029 | IVDR CE certificate |
| Class A (non-sterile) | A | n/a | IVDR self-declaration, until 30 Jun 2030 |
Conditions behind these dates:
- Certificates issued under IVDD Annex VI became void on 27 May 2025 at the latest.
- Self-declared IVDD devices can only use these dates if the conditions in IVDR Article 110(3c), as amended by Regulation (EU) 2024/1860, are met [10].
The 21 October 2026 government response. As covered last time, the response proposes recognising CE marked devices certified under the EU IVDR indefinitely. It does not say what happens to IVDD devices or to the 30 June 2030 date that applies to them. Until amending regulations are made, 30 June 2030 remains the legal end date for both IVDD and IVDR IVDs in GB.
Northern Ireland
- Which law applies: under the Windsor Framework, the EU IVDR has applied in Northern Ireland since 26 May 2022, the same as in EU member states. The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (in force 21 March 2024) added the NI rules needed to implement it, including penalties and enforcement notices [4].
- GB transition dates do not apply: those regulations omitted regulation 44ZA for Northern Ireland [7], and regulation 44ZB extends only to England, Wales and Scotland [8].
- Marking: CE marking is required, with an EU-recognised notified body where one is needed. Class A (non-sterile) IVDs can be self-declared against the IVDR. UKCA-only devices are not accepted in NI [6][12].
- UK notified bodies: if one is used, the device must carry the UK(NI) indication alongside the CE mark, as Article 7(2) of the Windsor Framework requires [4]. CE plus UK(NI) devices can be sold across the whole UK but not in the EU [6].
- Legacy IVDD devices: certificates extended under IVDR Article 110 remain valid in NI until the end of the relevant transition period in Article 110(3a) and (3b). The devices must still comply with the IVDD, have no significant changes in design or intended purpose, and present no unacceptable risk. The manufacturer also had to:
- have an IVDR quality management system in place by 26 May 2025;
- have lodged a formal application with a notified body by 26 May 2025;
- have a signed written agreement with that notified body by 26 September 2025 [13].
- Economic operators:
- GB-based manufacturers need a sole authorised representative in the EU or NI [6].
- A NI business bringing in goods from GB is an importer, with IVDR importer obligations [14].
- Four EUDAMED modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) became mandatory on 28 May 2026 [15].
- Selling NI IVDs into GB: IVDR-compliant IVDs that are "qualifying Northern Ireland goods" can be placed on the GB market with a valid CE marking indefinitely, under the UK Internal Market Act 2020 [6][4].