Unlock UKCA Certification for Medical Devices with Eurofins E&E

Eurofins E&E CML Ltd has been designated against the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended) by the MHRA.

Medical device manufacturers can now implement UKCA certification for the UK market with Eurofins E&E, with the scope accreditation covering a range of both active and non-active medical devices, giving businesses access to a trusted pathway for bringing their products to market in Great Britain.

Full details of the scope of accreditation can be found here.

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 standard.

For details of the services available, please contact our medical device team.