Medical Device File Template - UKCA Marking

Simplify the process of creating a compliant medical device file with our UK MDR (UKCA Marking) Medical Device File Template. Under the UK Medical Device Regulations 2002 (as amended), manufacturers must maintain a comprehensive technical file for each device they place on the UK market. This ready-to-use template provides a structured format for organizing all the necessary documentation to meet UKCA marking requirements and demonstrate conformity with the UK MDR.

✔ Pre-Formatted Medical Device File Template – Covers all essential UK MDR (UKCA) documentation requirements.

✔ Device Information & Classification – Clearly document device specifications, classification, and intended use.

✔ Risk Management & Safety – Ensure risk assessments, ISO 14971 compliance, and safety measures are in place.

✔ Design & Development Documentation – Include design outputs, verification, validation, and clinical evaluation data.

✔ Manufacturing & Quality Control Procedures – Document quality management system processes, including supplier management.

✔ Post-Market Surveillance – Ensure compliance with UK post-market surveillance and vigilance requirements.

✔ Audit-Ready Documentation & Compliance Tracking – Keep structured records for inspections, audits, and regulatory reviews.

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

This medical device file template is ideal for regulatory affairs teams, quality managers, and medical device manufacturers, ensuring a compliant and efficient UKCA certification process.

Download the UK MDR (UKCA Marking) Medical Device File Template today and streamline your regulatory compliance and documentation efforts!