UNITED KINGDOM RESPONSIBLE PERSON (UKRP)

There will be a new path to market medical device(s) in the UK as a result of 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, which is registered with the MHRA as a UK Representative and has access to the MHRA database for registering 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, as well as technical documentation, to ensure that it is suitable and meets MHRA requirements.

BREXIT IMPLICATIONS

The new UKCA marking must be used immediately after 1 January 2021, according to material provided on the UK Government’s website since 1 September.

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). 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

  • MHRA Registartion

  • 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 (URKP)

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

Best fee offer then any other service provided for the activities we carry out for the customers.

  • 24 X 6 Chat support

  • 6 days working and processing files

  • Economic pricing and polite staff

Class I: £950

Note: Each additional device / GMDN will incur fee of £100.

Class A and Class Is / r/ m: £1050

Note: Each additional device / GMDN will incur fee of £100.

Class B and Class IIa: £1200

Note: Each additional device / GMDN will incur fee of £100.

Class C and Class IIb: £1300

Note: Each additional device / GMDN will incur fee of £100.

Class D and Class III: £1400

Note: Each additional device / GMDN will incur 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

We UKRP service providers are authorized to apply for a certificate of free sale for non UK manufactures.

CONTACT US

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