UK Conformity Assessment
UKCA Medical Devices
The UKCA (UK Conformity Assessed) mark indicates that medical devices meet the relevant regulatory requirements for sale within Great Britain (England, Scotland, and Wales). It was introduced following the UK's departure from the European Union to replace the CE mark for products sold in the UK market.
The UKCA mark ensures that medical devices comply with the UK's specific standards for safety, health, and environmental protection. To obtain this certification, manufacturers must follow a conformity assessment procedure involving testing, documentation, and quality management. The UKCA mark became mandatory for most medical devices on January 1, 2021, with a transition period allowing CE-marked devices until June 30, 2024.
To obtain UKCA certification for UKCA medical devices and UKCA in vitro diagnostics, manufacturers must follow these steps:
1. Determine Device Classification: Based on its risk level, identify the medical device's classification (Class I, IIa, IIb, III).
2. Appoint a UK Responsible Person: Non-UK manufacturers must designate a UK Responsible Person to handle regulatory compliance.
3. Conformity Assessment: Conduct the necessary conformity assessment based on the device class. This includes:
- Class I: Self-certification.
- Class IIa, IIb, III: Assessment by an Approved Body (similar to an EU Notified Body).
4. Technical Documentation: Prepare comprehensive technical documentation demonstrating the device meets regulatory requirements, including:
- Device description.
- Design and manufacturing information.
- Risk management and clinical evaluation.
- Performance and safety data.
5. Quality Management System: Implement and maintain a Quality Management System (QMS) compliant with ISO 13485 or equivalent standards.
6. UK Declaration of Conformity: Draft and sign a UK Declaration of Conformity, stating the device complies with UK regulations.
7. Affix UKCA Marking: Once compliance is confirmed, affix the UKCA mark to the product, packaging, and accompanying literature.
8. Register the Device: Before placing it on the market, register the medical device with the Medicines and Healthcare Products Regulatory Agency (MHRA).
By following these steps, manufacturers ensure their medical devices meet UK regulatory standards and can be legally marketed in Great Britain.