UK Responsible Person

A UK Responsible Person is an individual or organisation – established within the United Kingdom – that assumes the regulatory responsibilities for a manufacturer outside of the United Kingdom. Carrying out specific tasks in relation to the manufacturer’s obligations.

Responsibilities include registering medical devices with the MHRA, ensuring documentation is correct and up-to-update and acting as a liaison between the manufacturer and regulatory committees.

The responsibilities of the UKRP are set out in the UK Medical Device Regulations 2002 (as amended). 

In summary UK Responsible Person must:

• Ensure that the declaration of conformity and technical documentations are drawn up. 
• Establish and manage that the appropriate conformity assessment procedures are carried out by the manufacturer.
• Maintain a copy of the above documentation and relevant certificates. Including all amendments and supplements for inspection by the MHRA. 
• Upon request from the MHRA, provide relevant documentation to demonstrate the conformity of a device. 
• Communicate with the MHRA concerning samples or access to device requests. Ensuring compliance with said request by the manufacturer. 
• Cooperate with the MHRA, on behalf of the manufacturer, on any preventive or corrective measures. Mitigating any risks posed by devices. 
• If contacted by healthcare professionals, patients and users report complaints and incidents related to the device.
• and much more. 

These are but a few examples of the responsibilities a UKRP must adhere to.

ODC Medical is well versed in quality assurance measures, regulatory improvements and industry standards. Allow us to assist you and your business by appointing ODC Medical as your UK Responsible Person.