Role of United Kingdom Responsible Person
Following Brexit, the United Kingdom has introduced new rules for the marketing of medical devices on its territory. As of 1st January 2021, non-British companies wishing to sell their medical devices in Great Britain shall appoint a “United Kingdom Responsible Person” (UKRP), i.e. a person or an entity acting as intermediary between the manufacturer and the British regulatory authorities.
Di Renzo Regulatory Affairs is a company specialised in advice and support enterprises operating in the sector of medical devices.
Our mission is to help our clients to obtain all authorisations required to market their products in the different markets, ensuring the compliance with the regulations in force as well as the safety of patients.
In order to offer a complete and qualified service to our clients, Di Renzo Regulatory Affairs has opened an office in Great Britain, located in London, that can take on the role of UKRP.
In this way, we are able to provide non-British companies with the support needed to adjust to the new legal provisions and continue the marketing of their medical devices in Great Britain.
We can perform the role of UKRP on behalf of manufacturers through the following service:
- Registering manufacturers and medical devices into the MHRA database
- Managing the notification of incidents according the applicable requirements
- Acting as contact point for British Competent Authorities
- Cooperating with Competent Authorities for any corrective action adopted to eliminate any risk presented by the devices
- Informing the manufacturer about complaints and reports by health professionals, patients or users regarding presumed incidents concerning a medical device for which they have been designed
Do not hesitate to contact us if you are interested to learn more about our UKRP service or if you need assistance for the registration of your devices in Great Britain. We will be glad to answer your questions and to offer a custom-made solution based on your needs.
