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.
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.