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UKCA Marking for Medical Devices
Current Landscape and Future Direction
Following a period of regulatory transition, the UK Government and the Medicines and Healthcare products Regulatory Agency (MHRA) are now advancing reforms to modernize the system, improve efficiency, and align with internationally recognized standards.
In this evolving context, DEKRA has taken the strategic decision not to offer UKCA certification services for medical devices until a clear, and stable regulatory framework is established. This decision also aims to minimize unnecessary financial and operational burdens for manufacturers by preventing investment in certification routes that may be subject to significant change.
The following whitepaper provides an overview of the current situation, anticipated regulatory developments, and DEKRA’s position regarding UKCA certification.
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 that comply with these regulations, including custom-made devices, can be placed on the Great Britain market until 30 June 2030.
A. Class I devices that do not require NB/AB involvement: 30 June 2030
B. MDD/AIMD Class I devices that belong to a higher class under MDR: Accepted until the sooner of the certificate's expiry or 30 June 2028.
C. Class Is/Im/IIa/IIb devices: Accepted until the sooner of the certificate's expiry or 30 June 2028.
D. Class IIb Implantable / Class III: Accepted until the sooner of the certificate's expiry or 30 December 2027.
- General IVD’s that do not require NB/AB involvement: 30 June 2030
- General IVD’s that will become up classified in the IVDR to:
- Class D: Accepted until 31 December 2027
- Class C: Accepted until 31 December 2028
- Class B: Accepted until 31 December 2029
- Class A (sterile): Accepted until 31 December 2029
- IVD’s classed as List A, List B or self test under IVDD, which will be reclassified as either Class B, Class C, or Class D under IVDR: 31 December 2027.
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
- Designated UK Approved Body – Authorized to assess and certify medical devices for UKCA marking.
- Global Presence – Decades of experience in medical device certification.
- Consistent Certification Standards – Meeting UK regulations through structured assessments.
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:
If the classification mandates the involvement of an Approved Body, identify the appropriate conformity assessment route.
Provide the required documentation to a UK Approved Body.
Evaluation of technical documentation and audit activities related to the quality management system.
Receive UKCA marking upon successful completion of the conformity assessments.
Ensuring continuous adherence by manufacturers to MHRA requirements, which is dependent on the quality of the technical dossier and quality management system (QMS).
If your products have valid CE certification, an abridged process may allow existing certification to be used as evidence for meeting certain UKCA requirements where applicable. For more details, please contact certification.uk@dekra.com.
Existing DEKRA clients can apply for UKCA certification by contacting their usual DEKRA representative, who will provide more information on how to submit the application.
New clients can apply for UKCA certification by contacting certification.uk@dekra.com.