Essential Requirements Checklist Template - UKCA Marking

Ensure your medical device meets UK MDR (UKCA) regulatory requirements with our UK MDR (UKCA Marking) Essential Requirements Checklist. Compliance with the UK Medical Devices Regulations 2002 (as amended) is mandatory for placing medical devices on the UK market. This comprehensive checklist provides a structured approach to assessing whether your device meets the essential safety and performance requirements necessary for UKCA marking.

✔ Pre-Formatted Essential Requirements Checklist – Covers all UK MDR (UKCA) compliance points.

✔ General Safety & Performance Requirements – Ensure compliance with design, manufacturing, and risk management standards.

✔ Biocompatibility, Chemical, & Biological Risks – Evaluate materials used and potential hazards.

✔ Sterility, Packaging & Labelling Compliance – Verify packaging integrity, sterility, and correct labelling.

✔ Electrical & Mechanical Safety Considerations – Assess device performance under normal and fault conditions.

✔ Clinical Evaluation & Performance Requirements – Ensure sufficient clinical evidence supports device claims.

✔ Post-Market Surveillance & Vigilance Compliance – Align with UK post-market requirements.

✔ Editable Digital Format – Fully customizable for various medical device types and risk classifications.

This UKCA marking checklist is ideal for regulatory affairs teams, quality managers, and medical device manufacturers, ensuring a structured, compliant, and efficient approach to UK MDR conformity.

Download the UK MDR (UKCA Marking) Essential Requirements Checklist today and streamline your regulatory compliance process!