Your Bridge to the UK Market – Trusted UKRP & MHRA Experts
UK Responsible Person (UKRP) and MHRA Registration Services
Before being sold in the United Kingdom, all medical devices, IVDs, and custom-made devices must be registered with the MHRA so-called MHRA Registration. This is mandatory for all types of devices. To be registered with the MHRA in the United Kingdom (England, Wales, and Scotland), devices must comply with the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023).
Where the manufacturer or their UK Responsible Person has a registered place of business in the UK, the MHRA device registration is feasible. If the manufacturer is located outside of the United Kingdom, they must nominate a UK Responsible Person with a registered business address in the United Kingdom.
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:
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01.05.2021: High-Risk Implantable and List A devices
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01.09.2021: Class IIb, IIa and List B devices
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01.01.2022: Class I and General IVD devices
Responsiblities of an UK responsible person (UKRP)
- 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.
MHRA Registration
Before being sold in the United Kingdom, all medical devices, IVDs, and custom-made devices must be registered with the MHRA so-called MHRA Registration. This is mandatory for all types of devices. To be registered with the MHRA in the United Kingdom (England, Wales, and Scotland), devices must comply with the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023).
Where the manufacturer or their UK Responsible Person has a registered place of business in the UK, the MHRA device registration is feasible. If the manufacturer is located outside of the United Kingdom, they must nominate a UK Responsible Person with a registered business address in the United Kingdom.
The following are the states for UK MHRA registration
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Appoint UK Responsible person if the manufacturer is located outside the UK
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Apply with MHRA by submitting the declaration of Conformity and UKRP Agreement
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Submit additional documents from the technical file if asked by MHRA
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Receive Registration details
UKRP and MHRA related FAQ’s
After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.
All medical devices sold in England, Scotland, and Wales must be UKCA certified unless CE marked under special transition rules (valid until mid-2028 for some devices)
