UK Conformity Assessed (UKCA) is the United Kingdom’s product marking introduced on 1 January 2021 after Brexit. UKCA shows that a product meets the health, safety, and environmental protection standards required by UK law. It applies to goods sold in Great Britain (England, Wales, Scotland) and was designed to replace the EU’s CE marking. However, CE is still accepted for most products. Notably, for medical devices, UKCA compliance via UK Approved Bodies is mandatory.
The current UKCA deadline for medical devices is 30 June 2028, after which UKCA marking becomes mandatory for all medical devices placed in the Great Britain market. For in vitro diagnostic (IVD) devices, the deadline is extended until 30 June 2030. Thus, CE marking is accepted only until these transition dates
What is UK Conformity Assessed for medical devices?
For medical devices, UK Conformity Assessed (UKCA) is the mandatory product marking required to place devices on the market in Great Britain (England, Wales, Scotland). It replaced CE marking after Brexit and ensures that devices meet UK Medical Device Regulations (based on the UK MDR 2002, amended post‑Brexit). Manufacturers must undergo conformity assessment through a UK Approved Body (not EU Notified Bodies), prepare technical documentation, issue a UK Declaration of Conformity, and affix the UKCA mark. While CE marking is still temporarily accepted for many products, medical devices face stricter requirements, thereby making UKCA compliance essential for continued market access in the UK.
Why was the UKCA introduced?
The UKCA (UK Conformity Assessed) mark was introduced after Brexit to replace the EU’s CE marking for products sold in Great Britain (England, Wales, Scotland). The main reason was that the UK needed its own independent conformity assessment system once it left the EU single market.
- Regulatory sovereignty: To give the UK full control over product safety, health, and environmental standards without relying on EU law.
- Market independence: CE marking is an EU framework. Whereas, UKCA ensures products meet UK‑specific regulations.
- Legal continuity post‑brexit: UK MDR 2002 (amended) and other statutory instruments required a domestic marking system to replace CE.
- Approved bodies: Certification must now be done by UK Approved Bodies, not EU Notified Bodies, ensuring oversight remains within the UK.
- Future flexibility: UKCA allows the UK to diverge from EU rules in the future, tailoring standards to national priorities.
Hence, UKCA was introduced to secure regulatory independence and ensure product compliance in Great Britain after Brexit. For medical devices, this shift is especially critical because only UK Approved Bodies can issue UKCA certificates, thereby making it a cornerstone of post‑Brexit compliance strategy.
CE mark vs UKCA
CE marking applies to products sold in the European Union (EU) and European Economic Area (EEA), while UKCA marking applies only to products sold in Great Britain (England, Wales, Scotland). Both marks certify conformity to safety, health, and environmental standards. However, they are legally distinct and require different regulatory bodies and standards.
| Aspect | CE Marking | UKCA Marking |
| Jurisdiction | EU + EEA + Northern Ireland | Great Britain (England, Wales, Scotland) |
| Legal Basis | EU Directives & Regulations (e.g., MDR 2017/745, IVDR 2017/746) | UK MDR 2002 (as amended post‑Brexit) |
| Regulatory Authority | European Commission + Competent Authorities in each EU country | MHRA (Medicines and Healthcare products Regulatory Agency) for medical devices |
| Assessment Bodies | EU Notified Bodies | UK Approved Bodies |
| Standards Used | EU Harmonised Standards | UK Designated Standards |
| Declaration of Conformity | Must reference EU directives/regulations and harmonised standards | Must reference UK regulations and designated standards |
| Market Access Validity | Mandatory for EU/EEA/Northern Ireland | Mandatory for Great Britain after transition deadlines |
| Transition Deadlines (Medical Devices) | CE accepted in GB until 30 June 2028 (medical devices) and 30 June 2030 (IVDs) | UKCA mandatory from 1 July 2028 (medical devices) and 1 July 2030 (IVDs) |
| Dual Marking | CE + UKCA both allowed during transition | Allowed until deadlines; after that, UKCA only |
| Status in GB | CE recognized until 30 June 2028 (medical devices) and 30 June 2030 (IVDs) | UKCA mandatory after deadlines |
| Status in EU | Mandatory | Not recognized |
| Northern Ireland Status | CE mandatory | Not valid |
| Manufacturer Obligations | EU Authorized Representative required if outside EU | UK Responsible Person (UKRP) required if outside UK |
| Labeling Requirements | CE mark minimum height 5mm, visible, legible, indelible | UKCA mark minimum height 5mm, visible, legible, indelible |
| Certificates Validity | CE certificates issued by EU Notified Bodies | UKCA certificates issued by UK Approved Bodies |
| Future Divergence Risk | EU may update MDR/IVDR independently | UK may revise UK MDR, creating divergence from EU |
Key features and requirements for UK Conformity Assessed for medical devices
- Scope and applicability: UK Conformity Assessed applies to all medical devices, IVDs, and accessories placed on the Great Britain market (England, Wales, Scotland). Dual CE + UKCA marking is permitted during the transition period.
- Legal framework: Governed by the UK Medical Device Regulations 2002 (as amended post‑Brexit). Initially aligned with EU MDR/IVDR but allows UK divergence in future updates. MHRA is the competent authority overseeing registration, vigilance, and enforcement.
- Conformity assessment: Conducted by UK Approved Bodies and not EU Notified Bodies. Required for medium‑ and high‑risk devices (Class IIa, IIb, III, and IVDs). Involves audits, technical documentation review, and certification issuance.
- Technical documentation: Must include device description, design/manufacturing processes, risk management, and clinical evaluation. Evidence of compliance with UK Designated Standards is required. Documentation must be available for MHRA inspection at any time.
- UK declaration of conformity: Mandatory document citing UK regulations and standards. Signed by the manufacturer or UK Responsible Person (UKRP). Serves as proof of compliance and must accompany the device.
- Economic operators: Non‑UK manufacturers must appoint a UK Responsible Person (UKRP). Importers and distributors have defined obligations under UK law. Roles mirror EU MDR’s framework but are UK‑specific.
- Labeling and marking: UKCA mark must be visible, legible, and indelible, minimum 5mm height. Can be affixed on the product, packaging, or documentation. Dual CE + UKCA marking allowed during transition. However, UKCA alone required post‑deadline.
- Transition deadlines: CE accepted until 30 June 2028 (medical devices) and 30 June 2030 (IVDs). After these dates, UK Conformity Assessed becomes mandatory for GB market access. Early preparation is advised to avoid bottlenecks with UK Approved Bodies.
Key terms in UKCA
- UKCA (UK Conformity Assessed): The product marking required for devices placed on the Great Britain market. Demonstrates compliance with UK regulations and designated standards. Mandatory after transition deadlines (2028 for medical devices, 2030 for IVDs).
- MHRA (Medicines and Healthcare products Regulatory Agency): The UK’s competent authority for medical devices. Oversees registration, vigilance, post‑market surveillance, and enforcement. Issues guidance and manages device listings in Great Britain.
- UKRP (UK Responsible Person): A mandatory representative for non‑UK manufacturers. Responsible for ensuring compliance, maintaining documentation, and liaising with MHRA. Mirrors the role of the EU Authorized Representative under MDR.
- UK Approved Body: Independent organizations authorized to conduct conformity assessments for UKCA. Listed in the UKMCAB database. EU Notified Bodies are not valid for UKCA certification.
- UK MDR 2002 (UK Medical Device Regulations 2002): The statutory instrument governing medical devices in the UK. Amended post‑Brexit to align with UKCA requirements. Provides the legal framework for classification, conformity, and enforcement.
- UK designated standards: UK’s equivalent of EU Harmonised Standards. Published by the UK government to support compliance under UKCA. Must be referenced in technical documentation and declarations.
- Declaration of Conformity (DoC): A legal binding document required under UKCA. Must cite UK regulations and designated standards. Signed by the manufacturer or UKRP, serving as proof of compliance.
- UDI (Unique Device Identification): A traceability system for medical devices. Required under UKCA from October 2026. Enhances post‑market surveillance and patient safety.
- eIFU (Electronic Instructions for Use): Digital format replacing paper IFUs. Mandatory under UKCA from October 2026. Ensures accessibility and reduces reliance on printed documentation.
In this blog, we have touched upon details on UK Conformity Assessed. For any assistance in securing the UKCA in a hassle-free manner, email at [email protected] or call/Whatsapp on 9996859227. We provide end-to-end comprehensive UKCA marking services.
