UK Responsible Person Services

As a UK Responsible Person, our role includes ensuring that your medical devices meet the regulatory requirements established by UK competent authority. We act as a point of contact for regulatory authorities. As your UKRP we would be responsible for:

• Managing your device registrations with the Medicines & Healthcare Regulatory Agency (MHRA). 

• Ensuring that your declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer. 
• Keep available a copy of your technical documentation, a copy of the declaration of conformity, and, if applicable, a copy of the relevant certificate, including any amendments and supplements, for inspection by the MHRA. 
• Responding to requests from the MHRA and providing them with all the information and documentation necessary to demonstrate the conformity of a device. 
• Provide samples of your device to the MHRA or allow them access to the device where the UK Responsible Person has samples. Where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access. 
• Co-operate with the MHRA on any preventive or corrective action taken to eliminate risks or mitigate risks posed by the device. 
• Immediately inform you about complaints and reports from healthcare professionals, patients and users about suspected incidents related to your device for which they have been designated. 
• Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these regulations and inform the MHRA and, if applicable, the relevant Approved body of that termination.