The UKCA marking is essential for placing medical devices on the market in Great Britain. This includes England, Scotland, and Wales. At Maven, we guide manufacturers in understanding and fulfilling UKCA requirements, ensuring their products meet the latest safety and compliance standards under the UK MDR 2002. With the right medical device consultants, compliance becomes more efficient and cost-effective.
What is the UKCA Mark and Why is it Important?
The UKCA marking (UK Conformity Assessed) is a product marking that replaces the CE mark for the UK market. It demonstrates that a medical device complies with the relevant UK regulations and is safe for use.
Devices must meet the requirements of the UK MDR, which replaced the EU MDR in the UK context. The UKCA regime has been in effect since 1 January 2021. From this date, if a product falls under UKCA requirements and meets all applicable standards, the UKCA marking can be applied, allowing the product to be placed on the Great Britain market.
Who Needs UKCA Certification?
UKCA for medical devices applies to all manufacturers who wish to sell medical devices in Great Britain. This includes:
- UK-based manufacturers
- Non-UK manufacturers who distribute in Great Britain
- Importers
Whether you’re introducing new products or maintaining a market presence, you’ll need to undergo UKCA marking under the UK MDR 2002. If your device was previously CE-marked under the EU MDR, it will be accepted on the Great Britain market until, at the latest, 30 June 2030, depending on the device type and classification.
Our medical device regulatory consulting services help assess whether your products require this certification and outline the necessary steps to ensure compliance.
Process of UKCA Marking
Understanding the UKCA marking process can be complex without the right guidance. Here’s a two-line overview:
The process requires meeting technical documentation standards and securing approval through a UK-recognized notified body or authority if applicable.
1. Classify the Device
Determine the classification of your medical device as per UK MDR rules.
2. Compile Technical Documentation
You must prepare a complete technical file, including risk analysis, clinical evaluation, and performance data. These are ongoing documents that need updates throughout the product lifecycle.
3. Engage a UK Responsible Person (UKRP) if required
For manufacturers based outside of the UK, it is mandatory to appoint a UK Responsible Person (UKRP) who would act as a local representative for the manufacturer in the UK.
4. Engage a Notified Body (if required)
For medium and high-risk devices (Class IIa and above), approval from a UK-approved Notified Body is necessary.
5. Declaration of Conformity
After meeting all requirements, manufacturers must draw up and sign a Declaration of Conformity.
6. Affix the UKCA Mark
Once all requirements are fulfilled, the UKCA marking can be applied to the device’s packaging and documentation.
