According to the UK Medical Devices Regulation 2002 (SI 2002 No.618, as amended), all medical device and in vitro diagnostic (IVD) manufacturers located outside the UK that want to place a medical device (or IVD) on the Great Britain market (England, Wales and Scotland) are required to appoint a UK responsible person (UKRP).
What are the obligations of the UKRP?
According to the directions provided by UK Medicines & Healthcare products Regulatory Agency (MHRA), a single UK Responsible Person (UKRP) will be appointed for ALL of the devices/IVDs of a manufacturer.
The UKRP will represent the manufacturer in all interactions with the MHRA, including device registration for new products. Additionally, according to the UK Medical Devices Regulation 2002 (Part II, 7A), the UKRP will:
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 manufacture
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
Provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
Comply with any request from the MHRA to provide such samples or access to the device
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
Inform the manufacturer about complaints, incidents and reports from healthcare professionals, patients, and users.
How Evnia-UKRP helps?
Evnia-UKRP has an established team of Regulatory Specialists and other highly qualified resources, providing a trusted compliance partnership throughout your device’s lifecycle. EVNIA-UKRP shall provide companies with a trusted UK Responsible Person that fulfils legal responsibilities and works in partnership with the Manufacturer to ensure regulatory compliance.
We are here to assist​
Need more details?
Phone Number
020 3386 9549
Email Address
info@evnia-ar.com
Website
https://www.evnia-ukrp.co.uk
Address
1 Canada Square, 37th Floor, London, E145AA
