---
title: UKCA Certification for Medical Devices from Eurofins E&E
description: UKCA Certification for medical devices from Eurofins E&E. Meet the requirements for Medical Devices for the GB market with our certification services.
---

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# UKCA Certification for Medical Devices

##### ![shutterstock_2375393299-1](https://landing.yorkemc.com/hs-fs/hubfs/shutterstock_2375393299-1.jpg?width=1000&height=248&name=shutterstock_2375393299-1.jpg)

 

## Your Trusted Partner for Medical Device Compliance

Eurofins E&E CML Ltd has been designated by the MHRA against the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended) - providing manufacturers with a recognised pathway to achieving UKCA certification for the GB market.

 With accreditation covering a range of active and non-active medical devices, manufacturers can ensure their products meet strict regulatory requirements and maintain patient safety and market confidence.

Full details of the scope of accreditation can be [found here](https://assets.publishing.service.gov.uk/media/680b46d7bc942a09683a27a4/AB_Eurofins_Medical_Devices_Scope_April_2025.pdf).

## Adding to our existing EU MDR and IVDR services

This designation builds on the services available through the existing EU Notified Bodies for the EU MDR & IVDR within the Eurofins network, allowing manufacturers to add both UKCA and CE certification for their medical devices, reducing costs and time to market. 

Designation as a UK Approved Body (UKAB) allows Eurofins E&E CML Ltd to undertake UKCA conformity assessments and issue UKCA certificates for a range of medical devices, supporting manufacturers in bringing their products to market in Great Britain. 

In addition to the UKCA accreditation for medical devices, Eurofins E&E (through Eurofins E&E CML Ltd) can provide manufacturers with certification to ISO 13485, an essential step to accessing the GB, EU and Global markets, as well as testing and certification to the IEC 60601 standards.

## Partner with Eurofins E&E for Medical Device Certification & Testing

With industry expertise, accredited testing facilities, and regulatory excellence, Eurofins E&E provides manufacturers with the confidence and efficiency needed to bring safe, compliant medical devices to market.

If you'd like to discuss any aspect of medical device testing and certification, submit your details and our medical device experts will be in touch.

### Your contact details

 

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Eurofins Electrical & Electronic UK Ltd  
Unit 1 Arabesque House  
Monks Cross Drive  
York  
YO32 9GW  
United Kingdom

 +44 (0)1237 423388  
[EEinfoUK@cpt.eurofinseu.com](mailto:EEinfoUK@cpt.eurofinseu.com)

 

###### About Us

Eurofins E&E UK provides compliance, certification and product testing services for manufacturers, retailers and product designers of electrical and electronic products.

From a simple review of a Declaration of Conformity to a complete, in-depth, ongoing compliance strategy for a range of products, we help you deliver compliant products to market, ensuring your products have the correct information, labelling and technical documentation to meet the needs of your customers, regulatory authorities and importers alike.

Our testing services include EMC, Wireless and Safety testing, test equipment calibration, Global Hazloc certification (including ATEX/IECEx), IP/IK testing and environmental/performance verification.

###### Links

- [Home](https://www.yorkemc.com)
- [Services](https://www.yorkemc.com/services)
- [Locations](https://www.yorkemc.com/contact/our-locations/)

###### Contact Us

 +44 (0) 330 430 3456

[EEinfoUK@cpt.eurofinseu.com](mailto:EEinfoUK@cpt.eurofinseu.com)

 Eurofins Electrical & Electronic UK Ltd  
 Unit 1 Arabesque House,  
Monks Cross Drive   
 York, North Yorkshire YO32 9GW

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Eurofins E&E UK consists of Eurofins Electrical & Electronic UK Ltd, Eurofins E&E CML Ltd & AQL EMC Ltd.

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