UKCA Marking for Medical Devices
Understanding UKCA Marking
UKCA (UK Conformity Assessed) came in to force when the UK left the European Union.
This marking is placed on medical devices and IVD’s to demonstrate conformity with the
Medical Device Regulation
(MDR 2002, as amended).
Although CE marking is still recognized in Great Britain, it is only valid within specific timelines and under requirements established by the Medicines and Healthcare products Regulatory Agency (MHRA). For the latest updates, please refer to the
MHRA website.
Transition From CE to UKCA Marking
After the expiration of the transitional periods for CE-marked devices, manufacturers will need to comply with UKCA marking regulations to continue selling their products in the UK market.
Devices compliant with EU MDR or EU IVDR
Medical Devices, compliant with EU MDD or EU AIMDD
In Vitro Diagnostic Devices compliant with EU IVDD
After the dates mentioned above, the device can only be placed on the market in GB if it has a valid MDR/ IVDR certificate (subject to timelines in point 1 above) or a valid UKCA certificate.
For further details, visit the MHRA website
here.
UKCA Marking: What Do You Need To Do?
To meet UK medical device regulations, manufacturers must:
- Register medical devices and IVDs with the MHRA, irrespective of their classification. Detailed information can be found on the MHRA website.
- Appoint a UK Responsible Person (for non-UK manufacturers) to assume manufacturer responsibilities.
- Classify medical devices correctly to determine the appropriate conformity assessment route.
- Obtain UKCA certification through self-declaration or third-party assessment (depending on device class) via a UK Approved Body like DEKRA Certification UK Ltd (8505).
Why Choose DEKRA?
DEKRA Certification UK Ltd is a designated UK Approved Body (8505) with substantial experience in assessing medical devices. Supported by a global network of offices and state-of-the-art laboratories, DEKRA provides certification services that facilitate worldwide market access for medical devices, including:
- Europe (CE Certification)
- Australia, Brazil, Canada, Japan, and the USA (under MDSAP certification)
- Singapore and Taiwan
UK Medical Device Regulations: Stay Updated
UK regulations are evolving, so we recommend checking the GOV.UK website for the latest information. Key resources include:
| Feature | CE Marking (EU) | UKCA Marking (UK) |
| Regulatory Body | European Commission | MHRA |
| Geographical Validity | EU, EEA, Switzerland | Great Britain (England, Scotland, Wales) |
| Recognition Deadline | Until 30 June 2028/2030 (varies by device) | Mandatory after deadlines above |
| Certification Process | EU Notified Body (if applicable) | UK Approved Body (if applicable) |
| Declaration of Conformity | Based on MDR/IVDR | Based on UK MDR 2002 (as amended) |
UKCA Certification Process
The process generally follows these steps when the involvement of an Approved Body is required:
1. Device Classification
If the classification mandates the involvement of an Approved Body, identify the appropriate conformity assessment route.
2. Application Submission
3. Assessment
4. Certification Issuance
5. Ongoing Compliance