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.

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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.
A.Menarini Diagnostics Ltd	qs@menarinidiag.co.uk	www.menarinidiag.co.uk	Janet Thomas	UK based, ISO 13485 Certified, UKRP for IVD's and Medical Devices.
Sebia UK Ltd	sales@sebia.co.uk	www.sebia.com	Tracey Staughton	ISO 13485, ISO 9001 & ISO 14001 Certified, UKRP for IVDs and Medical Devices.
Patient Guard	info@patientguard.com	https://patientguard.com/	David Small	Patient Guard is a leading UK and EU medical device and IVD regulatory consultancy, specialising in UK Responsible Person and EU Authorised Representative Services.

UK Responsible Person Directory

UK Responsible Person Directory

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