UK Responsible Person Directory

UK Responsible Person Directory

As part of the removal of the UK from the European Union from the 1st January 2021, the MHRA have laid down a new requirement for the appointment of a local natural or legal person to be responsible for the placement on the UK market of Medical Devices and IVDs where Legal Manufacturers do not have an establishment within the UK.

The new role is similar to the existing responsibilities of the EU Authorised Representative (AR) that is currently required for non-EU Legal Manufacturers to place devices onto the market in the EU under the IVD Directive. The use of the EU AR will continue under the new IVD Regulation. The UKRP is responsible for registering devices with the MHRA, and acts as the first point of contact for MHRA, and customers within the UK market.

The UKRP shall also share a degree of liability with the Manufacturer for the devices that it places on the market. The need for a UKRP is a critical additional piece of the IVD supply chain for non-UK based manufacturers and it is important that these persons have sufficient quality and reliability to ensure effective compliance, safety and effectiveness of the devices on the UK market.

Joining the Directory 

Signing up to the UKRP Directory page is free-of-charge for BIVDA member companies, and £199 plus VAT for non-members. Please follow the links below to join the page, and access BIVDA membership information.

 

Company Name Address Website Key Contacts Company Notes

IVDeology UKRP

info@ivdeology.co.uk

www.ivdeology.co.uk

Stuart Angell

ISO9001 certified UK based providers of consultancy, training and UKRP services for the IVD Industry

Qserve Group

globalreg@qservegroup.com

www.qservegroup.com

Daniëlle Motta

Qserve assists medical device and in-vitro diagnostics manufacturers with market access, medical device approvals, regulatory compliance and act as local representative in the EU, UK, US and China.

Compliance Solutions Life Sciences

edwin@cslifesciences.com

https://cslifesciences.com

Edwin Lindsay

Provider of regulatory advice to companies in the medical device industry on compliance including FDA processes, CE marks, UKRP. 

IMed Consultancy Ltd

hello@imedconsultancy.com

https://imedconsultancy.com

Alison Mills

K-based medical device and IVD UKRP. Regulatory experts providing global registrations, regulatory and QMS consultancy and training. 

Sapient Sensors Ltd

keith.robson@sapientsensors.com

www.sapientsensors.com

Keith Robson

Handheld, inexpensive, analysis and diagnostic sensors

Qarad, Part of the QbD group

ecrep@qarad.com

www.qarad.com

Ana Maria Leonte

ISO13485 and ISO27001 certified, consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry

confinis (UK) RP Ltd

ukrp@confinis.com

www.confinis.com

Howard Broadbridge

UKRP, regulatory affairs consultancy and training provider for IVD and medical device manufacturers with special expertise in combination products.

Pathaway Services Ltd

chidi.anyaeche@pathaway.co.uk

http://pathaway.co.uk/

Chidi Anyaeche

At Pathaway, we provide specialist UKRP, consultancy and facilitation services for the UK IVD and medical device market.

Alpha Laboratories

quality@alphalabs.co.uk

https://www.alphalabs.co.uk/

Cerys Baigent

Established since 1975, this specialist laboratory and clinical solutions provider is an importer, distributor and UKRP for the IVD industry.

Libera Voce

contact@liberavoce.co.uk

www.liberavoce.co.uk

Tim Briffitt

Expert provider of UKRP, Quality & Regulatory Services, including MHRA Registration, ISO13485 Lead Auditing, Management System Implementation & Validation.

Psephos

info@psephos.com

www.psephos.com

Mike Kilkelly

Psephos offer UKRP, and  decades of experience obtaining regulatory approvals for medical devices, strategic implentation of the right QMS. Psephos is ISO13485:2016 certfied. 

LFH Regulatory

info@lfhregulatory.co.uk

www.LFHRegulatory.co.uk

Laura Friedl-Hirst

UK based UKRP for IVD’s and medical devices. Consultancy services specialising in regulatory, quality and clinical including market access strategies.

 

Interested in becoming a member? Join us!

Copyright 2023 BIVDA Ltd is registered in England
Company Number 2687137
Registered Office is 299 Oxford Street (5th floor),
London, W1C 2DZ. VAT Number 563105858