UK Medical Device Regulations
What are the UK medical device regulations?
UK medical device law is mainly the Medical Devices Regulations 2002 (SI 2002/618, "UK MDR 2002"), but it applies differently in the two parts of the UK. Great Britain (England, Wales, Scotland) follows the amended UK MDR 2002, which is still built on the old EU Directives. Northern Ireland follows the EU MDR (2017/745) and IVDR (2017/746). The MHRA regulates both.
Approach: I read the UK MDR 2002 and the 2024 post-market surveillance amendment (SI 2024/1368) as published on legislation.gov.uk, plus MHRA guidance. I then checked GOV.UK and legislation.gov.uk for anything adopted in 2026.
How the 2002 Regulations are organised
- Part II, general devices: classes I, IIa, IIb and III, using the classification criteria of Directive 93/42 Annex IX (reg 7) [1].
- Part III: active implantable devices.
- Part IV: in vitro diagnostic devices (IVDs), including the rules for coronavirus test devices.
- Part 4A: post-market surveillance.
- Parts V–VII: approved bodies, fees and enforcement.
The Regulations do not cover medicinal products under the Human Medicines Regulations 2012, blood products, most human or animal tissues, or cosmetics (reg 3) [2].
Great Britain: what you need to place a device on the market
-
UKCA marking: a device "shall" not be placed on the market or put into service unless, where practical and appropriate, it bears a UK marking with any approved body number. The marking must also appear on the sales packaging and instructions for use (reg 10) [3].
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Registration: the person placing the device on the market must be established in GB, register the device with the Secretary of State and pay the fee (reg 7A) [4]. MHRA says all devices must be registered before being placed on the GB market, including IVDs, custom-made devices and system or procedure packs [5].
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UK Responsible Person (UKRP): a manufacturer based outside the UK must appoint a sole UKRP. The UKRP's duties (reg 7A(3)) include:
- holding the technical documentation and declaration of conformity;
- cooperating with the Secretary of State on preventive or corrective action;
- passing complaints and incident reports to the manufacturer;
- ending the relationship if the manufacturer breaches its obligations [4].
A UKRP "may be proceeded against" as the person placing the device on the market (reg 60) [6].
Using a CE mark in Great Britain
Devices that meet EU law are treated as meeting the GB requirements: regs 19B and 30A for the old Directives, and regs 19C, 44ZA and 44ZB for the EU MDR and IVDR [7][8]. Reg 1ZA sets when these provisions end [9]:
| Device route | CE-marked devices accepted in GB until |
|---|---|
| EU MDD / AIMDD compliant | 30 June 2028, or earlier if the certificate expires first |
| EU IVDD compliant | 30 June 2030, or earlier if the certificate expires first |
| EU MDR / IVDR compliant (including custom-made devices) | 30 June 2030 |
Source for the dates: MHRA guidance [10].
Exceptions:
- Self-declared Class I devices and general IVDs under the Directives only qualify if a notified body would be needed under the EU MDR or IVDR (for example, up-classified devices and reusable surgical instruments).
- Custom-made devices made to the MDD or AIMDD can no longer be placed on the GB market [10].
Post-market surveillance (GB, Part 4A)
Part 4A was added by SI 2024/1368 and took effect on 17.6.2025. It covers devices placed on the market from that date [11]. It requires:
- a post-market surveillance system and plan;
- field safety corrective actions and field safety notices;
- post-market surveillance reports, periodic safety update reports and trend reporting.
Serious incidents "must" be reported (reg 44ZH) [12]:
- no later than 15 days after the manufacturer becomes aware;
- no later than 10 days where there is a death or unanticipated serious deterioration in health;
- no later than 2 days for a serious public health threat.
Devices placed on the market before that date stay under the earlier rules (SI 2024/1368 reg 6) [13].
Northern Ireland
- The EU MDR has applied since 26 May 2021 and the IVDR since 26 May 2022.
- CE marking is required. The UKNI indication is also needed if a UK notified body does the conformity assessment.
- GB-based manufacturers must appoint an EU- or NI-based authorised representative.
- Custom-made devices must be registered with the MHRA within 28 days of being made available on the NI market.
- Incidents are reported to the MHRA [14].
- Devices that are "qualifying Northern Ireland goods" may be placed on the GB market as if they met the GB requirements (reg 2A) [15].
Upcoming changes
-
CE marks to be accepted indefinitely: on 21 October 2026 the government confirmed that GB will keep accepting CE-marked devices with no extra UK approval route. UKCA continues alongside it. The announcement does not identify any legislation laid yet (GOV.UK announcement). Until the law changes, the reg 1ZA end dates above remain the legal position.
-
Pre-market statutory instrument (planned for 2026): MHRA says it will:
- add an international reliance route;
- require unique device identifiers (UDI) and implant cards;
- reclassify some devices, aligning IVDs with IMDRF classifications;
- strengthen technical documentation requirements;
- bring the GB essential requirements closer to the EU's [16].
I found no made instrument yet.
-
Other recent instruments: searches turned up the Medical Devices (Fees Amendment) Regulations 2026 (SI 2026/197) and SI 2025/591. I could not open either text, so I can't confirm what they contain.
What changed for post-market surveillance?
Since mid-June 2025, Great Britain has had a full post-market surveillance (PMS) regime in a new Part 4A (regs 44ZC to 44ZR) of the UK MDR 2002, added by the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024/1368). It covers devices placed on the market or put into service on or after the date the 2024 Regulations came into force (reg 44ZD(1)) [11]. The main changes are a shorter incident-reporting deadline, MHRA sign-off of field safety notices before they go out, a 3-working-day deadline for documents MHRA asks for, and fixed timetables for PMS reports and PSURs.
Approach: I read Part 4A and SI 2024/1368 as published on legislation.gov.uk, and checked them against MHRA's June 2025 "summary of main changes" table and its current guidance.
Start date: the two sources differ by a day. The legislation.gov.uk note dates Part 4A to 17.6.2025 [17]. MHRA says the rules came into force on 16 June 2025 [18]. The SI itself only says it comes into force "6 months after the day on which they are made" (reg 1(2)) [19].
What changed
| Area | New GB requirement |
|---|---|
| Definitions (44ZC) | New terms: "PMS period" (from the first device of a model to the end of the lifetime of the last one), "incident", "serious incident" and "serious public health threat". "Serious deterioration" now covers self-administered treatment [17]. MHRA adds that a use error can be reportable when there is only a risk of serious deterioration, without it having happened [20]. |
| PMS system (44ZE) | The manufacturer "must" keep a PMS system for each device, proportionate to its risk, and use it through the PMS period. Its data must be used to update labelling and instructions, the risk analysis, the clinical or performance evaluation and the technical documentation. That updating duty does not apply to CE-marked devices placed on the market under regs 19B, 19C, 30A, 44ZA or 44ZB [21]. |
| PMS plan (44ZF) | MHRA describes the plan as "now mandatory within the regulations" [22]. The plan must state the device lifetime, how data is collected (including patient and public engagement), risk indicators and thresholds, and the statistical method for spotting trends. It must be given to MHRA within 3 working days of a request [23]. |
| Preventive and corrective actions (44ZG) | Actions "must" be notified to the UK Responsible Person (UKRP) and the approved body, where there is one. The approved body "must" check whether the action affects its certificate [24]. |
| Serious incidents (44ZH, 44ZI) | Report immediately once a causal link is established, and in any case no later than: 15 days (the general limit), 10 days (death or unanticipated serious deterioration) or 2 days (serious public health threat). The report must include unique device identifiers (UDIs). MHRA and the manufacturer "may" agree periodic summary reports for similar incidents [12]. MHRA says the deadline for anticipated serious deterioration was previously 30 days [22]. A final investigation report is now required. Investigation documents are due within 3 working days of a request, and the device must not be altered in a way that could affect later evaluation before MHRA is told [25]. |
| Field safety corrective actions (FSCAs) and field safety notices (44ZJ) | Before taking an FSCA, the manufacturer must produce a risk assessment and send MHRA an initial report plus the draft notice. In urgent cases these can follow the action instead. The notice must give UDIs in a searchable format. A final report with evidence that the action worked is required [26]. |
| FSCAs outside GB (44ZK) | New duty: if the same model is on the GB market but the same FSCA is not being taken in GB, the manufacturer must report it to MHRA and explain why GB is not included [27]. |
| PMS report (44ZL) | Applies to lower-risk devices: Class I, IVDR Class A/B, and IVDs not on Annex II of the IVD Directive. First report within 3 years of placing on the market, then updated at least every 3 years [28]. |
| Periodic safety update report, PSUR (44ZM) | All other devices. Class IIa: first PSUR within 2 years, then at least every 2 years. Everything else: within 1 year, then yearly. PSURs go to the approved body. For Class III, implantable, active implantable and Annex II IVDs, the approved body must review each PSUR and issue a report [29]. |
| Trend reporting (44ZN) | Report significant increases in how often or how severely incidents occur, measured against the method in the PMS plan. For IVDs, also report increases in erroneous results. An initial and a final report are required [30]. MHRA says this also covers incidents that are not individually reportable [31]. |
| Incidents and signals flagged by MHRA (44ZO, 44ZP) | If MHRA notifies an incident, the manufacturer must treat it as serious or explain why it is not. If MHRA disagrees, it must be treated as serious. Risks MHRA identifies must be investigated and reported on [32][33]. |
| Record keeping (44ZQ, 44ZR) | The manufacturer and UKRP keep PMS documents for the PMS period or 15 years (implantables) / 10 years (other devices), whichever is longer. MHRA "may" extend the 3-working-day deadline [34][35]. |
Scope and transition
- Custom-made devices are only partly covered. They are subject to regs 44ZC to 44ZJ and 44ZO to 44ZR, but not the PMS report, PSUR or trend-reporting rules. They are also exempt from the parts of the plan on post-market clinical follow-up and periodic reports (44ZF(3)(g)-(h)) [11].
- Excluded entirely: devices for clinical investigation or performance evaluation, and devices supplied under a regulation 12(5), 26(3) or 39(2) authorisation [11].
- System or procedure packs are outside the PMS report and PSUR duties unless they include a device without a UKCA or CE mark, or combine devices in a way that does not match their original intended use [28].
- Devices already on the market before the start date: SI 2024/1368 reg 5 deletes specified sections and indents from Schedule 2A. Reg 6 keeps the old Schedule 2A wording for devices placed on the market or put into service before that date [36][13].
- Other definitions: reg 3 adds a definition of "working day" to reg 2(1) [37].
- Northern Ireland: reg 4, which inserts Part 4A, extends to England, Wales and Scotland only [19]. Northern Ireland stays on the EU MDR and IVDR.
Electronic reporting
For GB submissions, MHRA updated the reporting templates for manufacturer incident reports and FSCA reports on its online portal (MORE). The new GB templates went live on 16 June. The old templates could be used until 16 October 2025, with the new fields, such as UDI, approved body certificate number and GB device and user numbers, typed into comment fields. Reporting incident codes from the international regulators' forum (IMDRF) became mandatory. MHRA withdrew that interim guidance on 16 October 2025 [38].
When will the new UK framework apply?
No date has been set yet for the new GB framework to apply. The planned pre-market regulations exist only as a draft, the Medical Devices (Amendment) Regulations 2026. MHRA gives no in-force date for them, only that they will come in "subject to" transitional provisions. The one firm date is for the CE-marking changes: the government says that legislation will be made before 30 June 2028.
Approach: I read MHRA's "Implementation of the future regulations" guidance and its reform roadmap. I then checked GOV.UK for later material: the May 2026 call for evidence on the draft 2026 Regulations, and the 21 October 2026 government response on recognising CE-marked devices indefinitely.
Where each part of the reform stands
| Part of the reform | Status and timing |
|---|---|
| Post-market surveillance (new Part 4A of the UK MDR 2002) | Already in force. MHRA says it came into force on 16 June 2025 [18]. |
| Pre-market statutory instrument: international reliance, UDI, implant cards, reclassification, IVD changes, essential requirements | MHRA says this instrument "will follow in 2026", and that rollout will be "proportionate, phased" [39]. The roadmap's last milestones are introducing the SI into Parliament, then "New pre-market SI in force subject to TP [transitional provisions], guidance publ." The roadmap timeline runs to December 2026, but the extracted text does not show which month each milestone falls in [40][41]. MHRA published the draft 2026 Regulations on the WTO notification portal on 8 May 2026. Its stakeholder impact survey ran to 19 June 2026, and neither page gives an in-force date (GOV.UK news, 11 May 2026; call for evidence). MHRA calls the draft a "proposed" set of changes and says survey responses will "help shape the final regulatory framework" (questionnaire guidance, pp. 3–5). |
| CE-marked devices accepted indefinitely | The government intends to: (1) recognise devices certified under the EU MDR and IVDR indefinitely; and (2) accept devices under the old EU Medical Devices Directive until the end of the EU's own transition period, which is currently 31 December 2028 (instead of 30 June 2028). On timing, it says: "Subject to parliamentary approval, these legislative changes will be made prior to the end of the earliest relevant transition period, which is 30 June 2028" (Government response, 21 October 2026, pp. 18, 21). The 21 October press release and the consultation outcome page give no dates for laying or commencing the legislation (press release; consultation page). |
What applies in the meantime
- CE marks in GB: until the amending legislation is made, MHRA's current end dates still stand: 30 June 2028 for MDD/AIMDD devices and 30 June 2030 for IVDD and EU MDR/IVDR devices. MHRA says that while the consultation runs, "the above transition arrangements remain in place" [10].
- UKCA route: for now, UKCA requirements are still based on the old EU Directives, as modified by Schedule 2A of the UK MDR 2002 [42]. The government says this route "is being modernised through the pre-market statutory instrument" (press release).
- Northern Ireland: none of this changes NI, which stays on the EU MDR and IVDR. "Qualifying Northern Ireland goods" can still be placed on the GB market with a valid CE mark indefinitely [43].
I found no made pre-market instrument and no commencement date. The draft's transitional provisions will set when each requirement (such as UDI or reclassification) bites, but I couldn't read them: the draft is on the WTO notification portal, not on GOV.UK.