As a Medical Device Manufacturer, understanding the legal requirements for medical devices in the UK can be a daunting task. One of the critical requirements is the appointment of a UK Responsible Person. In this blog post, we will discuss the UK responsible person role and legal requirements for medical devices.

What is a UK Responsible Person?

A UK Responsible Person is an individual or a company appointed by a non-UK manufacturer to act as their Authorised Representative in the UK. The main role of the UK responsible person is to ensure the non-UK manufacturer’s compliance with the UK’s medical device regulations, including handling inquiries and complaints about the medical devices, keeping records of the devices sold in the UK, and cooperating with the regulatory authorities.

What are the legal requirements for UK Responsible Persons?

To fulfill their role effectively, UK Responsible Persons must meet several legal requirements, including:

To ensure compliance with the UK responsible person requirements, Medical Device Manufacturers should:

Why is a UK Responsible Person required?

Compliance with the UK medical device regulations is crucial for Medical Device Manufacturers to ensure the safety and effectiveness of their products and avoid legal and financial penalties. Appointing a UK Responsible Person is a legal requirement for non-UK manufacturers to market their devices in the UK effectively. Understanding the UK responsible person role and legal requirements, will ensure your compliance and maintain your market access and reputation in the UK.

Ready to Get Started? - Get a Quote Now

Contact us about our services or if you need any more information. We're here to help!

Contact Us
ukrepmed main site logo

UK Rep Med Limited

Unit D, Crondall Place. Coxbridge Business Park , Alton Road, Farnham, GU10 5EH, UK.


Phone: +44 (0) 1252 912933

© 2023 UK RepMed Limited UK Registration Number: 10640484