UK Responsible Person
Place Your Medical Device in the UK Market with the MDSS-UK Responsible Person Service
MDSS-UK RP Ltd. is the UK Responsible Person — UKRP — for medical device manufacturers located outside the United Kingdom. MDSS-UK RP Ltd., established in the United Kingdom, is your UK Responsible Person, acting on behalf of medical Device manufacturers located outside the Great Britain market and works in relation to specified tasks with the medical device manufacturer’s obligations under the current regulation.
MDSS is ready to support Medical Device Manufacturers located outside the UK as trade with the UK has changed significantly. The need for a UK Responsible Person is now a requirement and MDSS understands the new UK marketplace.
Our experienced professional team of Regulatory Affairs experts will guide you through all the requirements of the UK MHRA (Medicines and Healthcare products Regulatory Agency).
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UK Responsible Person Tasks
1.
Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
2.
Keep available a copy of the 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.
3.
In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
4.
Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
5.
Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
6.
Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
7.
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 notified body of that termination.
Select MDSS as Your UK Responsible Person (UKRP)!
Contact MDSS-UK RP Ltd.
- Address 6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK
- Email info@mdss-ukrp.com
- Phone +44 7898 375 115