UNITED KINGDOM RESPONSIBLE PERSON (UK REP)
There will be a new path to the market medical device(s) in the UK due to Brexit called the UK Conformity Assessment Mark (UKCA). To register their devices with the UK Medicine Health and Regulatory Authority (MHRA), manufacturers outside the UK will need to appoint a UK Responsible Person (UK Rep).
We provide UKRP services from our London office, registered with the MHRA as a UK Representative and has access to the MHRA database to register the medical device and IVD manufacturers.
One of a UK Responsible Person’s (UKRP) tasks is to evaluate the declaration of conformity (DOC) and current CE Certificate and technical documentation to ensure that it is suitable and meets MHRA requirements.
BREXIT IMPLICATIONS
The new UKCA marking must be used immediately after January 1 2021, according to material provided on the UK Government’s website since September 1.
From January 1, 2021, all medical devices including in vitro diagnostic medical devices (IVDs) sold in the United Kingdom, must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA). However, there will be a registration grace period:
01.05.2021: High-Risk Implantable and List A devices
01.09.2021: Class IIb, IIa and List B devices
01.01.2022: Class I and General IVD devices
RESPONSIBILITIES OF AN UK RESPONSIBLE PERSON (URKP)
The following are the major services we provide.
Review of customer-supplied information and GMDN Code
Review of Declaration of Conformity and CE Certificates if avaliable.
Review of Technical Documentation and send GAP assessment report if requested by client
Drafting and Signing the UK Representative agreement
Arrange Certificate of Free Sale
On request, provide the MHRA with all relevant information
collaborating with MHRA on any preventative action taken to eliminate possible hazards
Notify the manufacturer of any accidents or concerns.
Notify MHRA, if the manufacturer violates its responsibilities.
PROCESS OF APPOINTING AN UK RESPONSIBLE PERSON (UK REP)
The step by step process detailed below
Submit signed dated declaration of Conformity along with related CE Certificate if avaliable.
Approve quotation and make UKRP annual fee
Approve the draft submitted and signed the mutual agreement
MHRA Application
BEST PRICE OFFER
Class I: £950
Note: Each additional device / GMDN will incur a fee of £100.
Class A and Class Is / r/ m: £1050
Note: Each additional device / GMDN will incur a fee of £100.
Class B and Class IIa: £1200
Note: Each additional device / GMDN will incur a fee of £100.
Class C and Class IIb: £1300
Note: Each additional device / GMDN will incur a fee of £100.
Class D and Class III: £1400
Note: Each additional device / GMDN will incur a fee of £100.
UK MDR 2002
MHRA REGISTRATION
MHRA registration is mandatory for the sale of medical devices in the United Kingdom.
UK MDR 2002
CERTIFICATE OF FREE SALE
Our UKRP service providers are authorized to apply for a certificate of free sale for non-UK manufacturers.