Guide
UKCA 2026: Market access UK for Swiss Medtech manufacturers
Prof. Dr. Dr. h.c. Frank Stein, healthcare projects – consulting & management Stein
Jun 1, 2026
The UK remains an attractive market for Swiss medical technology, but it is a regulatory market of its own. Five years after Brexit, the UKCA marking has lost its original central role, as the United Kingdom returns to convergence with the EU. This guide shows the status as of 2026 and what Swiss manufacturers need to do to prepare for access to the GB market.
1. Background: The UK is a separate regulatory space
Since the United Kingdom’s withdrawal from the EU on 1 January 2021, the new EU medical device regulations do not apply to the placing on the market of medical devices in the GB market (England, Wales, Scotland), but the Medical Devices Regulations 2002 (UK MDR 2002) in their current version do. The UK did not adopt the EU MDR (2017/745) and IVDR (2017/746) regulations, but continued its own regime based on the previous directives. As a visible sign of conformity, the UKCA (UK Conformity Assessed) marking was introduced.
The terminology is important: the GB market (Great Britain) includes England, Wales and Scotland and is governed by the UK MDR 2002 and the UKCA marking. The broader “UK” also includes Northern Ireland, for which – as shown below – a separate, EU-oriented regime applies. Anyone serving the British market must plan the two areas separately from the outset.
For Swiss manufacturers, another point is crucial: the Agreement on the Mutual Recognition of Conformity Assessments between Switzerland and the EU (MRA) does not extend to the United Kingdom. Switzerland is considered a third country with regard to the UK market. This means that access to the GB market is a separate path that triggers its own obligations, independent of existing EU MDR/IVDR compliance.
A territorial peculiarity arises from the Windsor Framework: In Northern Ireland, the EU MDR and IVDR still apply; products require a CE marking there, supplemented by the UKNI mark if a UK Approved Body is involved (CE UKNI). The UKCA marking is not recognized in Northern Ireland.
2. UKCA – Requirements for marking
The UKCA marking confirms compliance with the UK MDR 2002. It is affixed on the basis of a Declaration of Conformity signed by the manufacturer. If a UK Approved Body is involved in the conformity assessment, its identification number must be placed below the UKCA logo. Four requirements are central:
- UK Responsible Person (UKRP): Manufacturers without a UK establishment – including all Swiss manufacturers – must appoint a UKRP. The UKRP acts as the point of contact for the MHRA and is jointly responsible for registration and post-market obligations. The role is functionally equivalent to the CH-REP (Swiss Representative) for the Swiss market.
- MHRA registration: All risk classes (Class I, IIa, IIb, III, as well as all IVD categories) must be registered with the Medicines and Healthcare products Regulatory Agency before being placed on the market – as an ongoing requirement, not as a one-off action.
- UK Approved Body: For products above Class I and for sterile or measuring Class I products, a UK approved body (e.g. BSI UK, SGS UK, DEKRA UK) is required. Non-sterile, non-measuring Class I products and General IVDs can, however, be self-declared. Available capacity is still considered to be limited.
- Post-Market Surveillance: Stricter PMS requirements (SI 2024/1368) including PMS plan, PSUR, and tiered incident reporting deadlines – 2 days for serious risk to public health, 10 days for death or unexpected serious deterioration, 15 days for expected serious deterioration – and reporting via the MORE portal will apply from 16 June 2025. They apply equally to UKCA and CE marked products.
3. Transitional periods for CE-marked products
The mandatory UKCA transition originally scheduled for June 30, 2023, has been postponed several times. Currently, the following acceptance deadlines apply to CE-marked medical devices in the GB market:
| product category | Valid on the GB market until |
|---|---|
| Medical devices with valid CE certificate under MDD/AMDD (90/385/EEC, 93/42/EEC) | Certificate expiration or 30.06.2028 (whichever comes first) |
| IVD with valid CE certificate according to IVDD (98/79/EC) | Certificate expiration or 30.06.2030 (whichever comes first) |
| Medical devices with CE marking under EU MDR (2017/745) | 30.06.2030 |
| IVD with CE marking according to EU IVDR (2017/746) | 30.06.2030 |
| UKCA-marked products under UK MDR 2002 | indefinite (subject to new UK regulation) |
Source: MHRA, “Regulating medical devices in the UK” – Timelines for acceptance of CE marked medical devices in Great Britain.
deadlines
30.06.2028
MDD/AIMDD CE products on the GB market
30.06.2030
EU MDR/IVDR and IVDD CE products
indefinite
UKCA products (UK MDR 2002); indefinite CE recognition as MHRA proposal
4. Strategic shift in MHRA’s course 2025/2026
On 22 July 2025, the MHRA published the second part of its response to the “Routes to market and in vitro diagnostic devices” consultation and announced its intention to seek an indefinite recognition of CE-marked medical devices on the GB market in the future. On 16 February 2026, the MHRA launched a targeted consultation (closing on 10 April 2026) to this end, with three core proposals: (i) extending the MDD/AIMDD transition period from 30 June 2028 to 31 December 2028 to align with the EU, (ii) indefinite recognition of products compliant with EU MDR/IVDR without the 30 June 2030 deadline, and (iii) an “International Reliance Route” for products classified at a higher level in the UK than under EU law. The MHRA’s response to this consultation was still pending at the time of writing.
Parallel to this, the MHRA has pushed forward the actual reform of the pre-market framework: on 8 May 2026, the draft Medical Devices (Amendment) Regulations 2026 was published via the WTO notification portal; the accompanying stakeholder impact survey ran until 19 June 2026, and the WTO comment period until 7 July 2026. The draft enshrines a standalone GB framework with closer alignment to EU MDR/IVDR and IMDRF guidance, introduces an international reliance pathway (USA, Canada, Australia), and tightens, among other things, classification, technical documentation, and UDI requirements. According to the current timetable, the regulation is expected to go to Parliament by the end of 2026, be enacted in December 2026, and come into force in June 2027; the international reliance pathway is expected to follow in mid-2028. Important: the indefinite CE recognition is not part of this draft, but is being addressed separately via the consultation mentioned above.
The UKCA marking remains a valid market access route, but it is practically losing importance: a double conformity assessment is to be abolished in the future.
”The UKCA marking will be a legally available, but increasingly secondary route to market access by 2026.”
5. What this means in concrete terms for Swiss manufacturers
The third-country status of Switzerland with respect to the UK market and the announced change of course by the MHRA have six practical consequences for the market access and QA strategy:
- Prioritize CE strategy: For most manufacturers, maintaining a valid EU MDR/IVDR certification is the most pragmatic approach – CE acceptance will last at least until 2028/2030 and is proposed by the MHRA to be indefinite. A standalone UKCA certification is only worthwhile in certain cases.
- UKRP must be clearly regulated: Swiss manufacturers must compulsorily appoint a UK Responsible Person – analogous to the CH-REP. The contract should clearly assign registration, incident reporting, and PMS participation.
- PMS System Adaptation: The requirements applicable from June 2025 (SI 2024/1368) require adaptations in the QM system – ISO-13485 procedures, trend reporting, and access to the MORE portal.
- Factor in MRA gap: Because the CH-EU MRA does not cover the UK, EU conformity does not replace the GB-specific registration and UKRP pathway. Both markets need to be planned separately.
- Regulatory observation: The ongoing CE marking consultation and the draft Medical Devices (Amendment) Regulations 2026 should be actively followed – especially in the case of Software as a Medical Device (SaMD), AI-based products, and the new UDI and classification requirements.
- Treat Northern Ireland separately: EU law remains the main law for the Northern Irish market; a UKCA marking alone is not sufficient there.
6. Conclusion
The UKCA marking is a legally existing, but increasingly secondary, market access route by 2026. With the proposed indefinite recognition of CE-compliant products and the draft Medical Devices (Amendment) Regulations 2026, the United Kingdom is pragmatically returning to regulatory convergence with the EU. For Swiss manufacturers, this means: Clean EU MDR/IVDR compliance, a designated UK Responsible Person, and a PMS system according to SI 2024/1368 fully cover market access to GB for the time being. The only thing to keep in mind is that the UK must be treated separately from the EU – and, in the absence of an MRA, also separately from Switzerland – from a regulatory perspective.
Start exporting to the UK
Are you planning to sell your medical devices in the UK? Switzerland Global Enterprise supports Swiss exporters with market information and a network of regulatory experts. You can get initial information on market access in the UK via ExportHelp.
Links & Sources
- GOV.UK – Medical devices: conformity assessment and the UKCA mark
- GOV.UK – Regulating medical devices in the UK (Acceptance deadlines for CE-marked products)
- MHRA – Approved bodies for medical devices
- Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024/1368 (in force since 16.06.2025) – Primary text and implementation guide
- MHRA/GOV.UK – Implementation of the future regulations (Government response to “Routes to market and IVDs,” 26.02 and 22.07.2025)
- MHRA – Targeted consultation on indefinite recognition of CE marked devices (16.02.-10.04.2026)
- MHRA/GOV.UK – Draft Medical Devices (Amendment) Regulations 2026 (WTO notified 08.05.2026)
- MHRA/GOV.UK – Stakeholder impact survey
About the author
[Prof. Dr. Dr. h.c. Frank Stein] is an independent consultant for Regulatory Affairs and Healthcare IT and runs the Swiss consulting company healthcare projects consulting & management Stein (Liestal BL). With a background in biomedical engineering and over 30 years of experience in the DACH region, he supports manufacturers, importers and suppliers in the areas of EU MDR/IVDR, ISO 13485, ISO 27001, ISO 42001, EU AI Act, as well as EHDS/SwissHDS.
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