Understanding the UKCA Certification for Medical Devices

Navigating UKCA certification is essential for manufacturers seeking access to the Great Britain market. Understanding the regulatory landscape, transitional provisions, and compliance steps is key to success.

About this Guide

The UKCA (UK Conformity Assessed) marking is now the mandatory certification for medical devices entering the Great Britain market (England, Scotland, and Wales).

Following Brexit, the regulatory framework for medical devices has shifted, and manufacturers must ensure compliance with UK-specific requirements.

This guide provides a comprehensive overview of the UKCA certification process, including:

The regulatory background and key legal requirements
Step-by-step guidance on obtaining the UKCA mark
Compliance deadlines and transitional provisions
Post-market surveillance and vigilance obligations
Upcoming regulatory changes and their impact on manufacturers

Who Should Read This?

This guide is essential for medical device manufacturers, regulatory professionals, and quality assurance teams looking to ensure smooth market access in Great Britain. Whether you are transitioning from CE marking or entering the market for the first time, this resource will help you navigate the complexities of UKCA certification.