Trusted UKRP Services to Register Your Medical Devices!
UK Responsible Person Service
Are you a manufacturer of low-volume or low-priced medical devices seeking a local UK RP (Responsible Person) to act on your behalf at modest cost?
Why do you require a UK Responsible Person and UKCA Registration services if you already have achieved the CE mark?
Since leaving the European Union, the CE mark is not enough to market a Medical Device for sale within the United Kingdom.
Manufacturers not located in the UK wishing to place a CE-marked device on the Great Britain and Northern Ireland market need to appoint a elementor-icon-list-text and get their devices UKCA registered with MHRA.
Without a UK medical device registration, you are unable to lawfully place your device on the Great Britain and Northern Ireland Market.
See the United Kingdom Government Guidelines below.
Which Medical Devices are covered?
All Medical Devices with the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Device Directive (AIMDD) with a valid declaration and CE marking.
This covers categories I, IIa, IIb, and III, plus In Vitro Diagnostic Devices (IVD) compliant with the EU In Vitro Diagnostic Devices Directive (IVDD) categories A, B, C and D.
Device Registration Service
We offer a low-cost and efficient UKCA product registration service for international manufacturers who appoint us as their UKRP for medical devices.
This means you or your local distributor (s) will be able to market your devices in the Great Britain and Northern Ireland market.
Since leaving the European Union, a CE mark is insufficient to market a Medical Device or IVDD for sale in the UK. For compliance, manufacturers must also meet the requirements of UKCA for medical devices
Non-UK based manufacturers wishing to place a device on the Great Britain and Northern Ireland markets need to appoint a local UK Responsible Person and register their products with the MHRA.
Failure to register your devices with MHRA or appoint a UKRP will mean that you are unable to lawfully place your device on the Great Britain and Northern Ireland markets. This makes MHRA UK Responsible Person registration an essential step for compliance.