If you are a medical device manufacturer looking to gain access to the medical device market in Great Britain, Templar Consulting can make this happen.
Brexit will significantly affect medical device companies who wish to sell products across the Channel, particularly regarding in-country representation.
The UK Medical Devices Amendment (EU Exit) regulations has introduced a new economic operator in the UK market, “UK Responsible Person” (UKRP). The UKRP has been defined as a person established in the United Kingdom who will act on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.
A UKRP must be appointed from January 1st 2021, and the UKRP must register the manufacturer, any relevant importers, and the devices with the MHRA. The MHRA plans to eventually replace the CE mark with a UK Conformity Assessment (UKCA) mark; its use is currently expected to become mandatory on June 30, 2023.
The UK Medical Devices Amendment (EU Exit) regulations has introduced a new economic operator in the UK market, “UK Responsible Person” (UKRP). The UKRP has been defined as a person established in the United Kingdom who will act on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.
A UKRP must be appointed from January 1st 2021, and the UKRP must register the manufacturer, any relevant importers, and the devices with the MHRA. The MHRA plans to eventually replace the CE mark with a UK Conformity Assessment (UKCA) mark; its use is currently expected to become mandatory on June 30, 2023.
Duties of a UKRP
- 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
- 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
- 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
- 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 appointed
