EU MDR Services 

EU Notified Body Services for the Medical Device Regulation (MDR) 2017/745

 EU IVDR Services 

EU Notified Body Services for the In-Vitro Diagnostic Regulation (IVDR) 2017/746

UKCA Certification 

UKCA Certification of Medical Devices for the GB Market

FDA Submissions for the US & Canada 

Expert services to assist in obtaining FDA Approval

CB Scheme Certification 

Test and certify your active medical devices for global markets with the CB Scheme

NRTL Certification for Active Medical Devices 

MET Mark NRTL certification for the US & Canada 

The market for medical devices is global, and in all important markets, regulatory requirements are in place to ensure that products meet the highest standards and do not present a risk to patients or users alike.

For example, products must comply with EU Regulations in the European Economic Area, the requirements of the MHRA in the UK, the FDA’s requirements in the United States, Health Canada’s requirements in Canada, JPAL regulations in Japan and TGA requirements in Australia.

Eurofins Electrical & Electronics provides certification services for medical devices for the EU & GB Markets as well as for the US & Canada.

CE Marking & Conformity Assessment for EU Markets

In Europe, the use of a Notified Body (NB) is required in the approval or certification process for medical devices.

Our network of accredited laboratories and certification bodies offers a comprehensive range of testing and certification services for both active and non-active medical devices and in vitro diagnostic medical devices in line with the requirements of the MDR (Medical Device Regulation) for EU markets.

To assist you in placing your medical devices onto the EU market, we have a number of Notified Bodies (NB) that can provide conformity assessment to the Medical Device Regulation (MDR) 2017/745.

Medical Device Regulation (MDR) 2017/745

Our certification bodies in Finland (NB No. 0537) and Italy (NB No. 0477) are Notified Bodies under the MDR (2017/745) for both active and non-active medical devices.

In-Vitro Diagnostic Regulation (IVDR) 2017/746

Our certification body in Finland (NB No. 0537) is a Notified Body under the In-Vitro Diagnostic Regulation (IVDR) 2017/746.

Our EU Notified Bodies

• Italy - Eurofins Product Testing Italy Srl - NB No. 0477
• Finland - Eurofins Electric & Electronics Finland Oy - NB No. 0537

The current scope of accreditation for all EU Notified Bodies can be found on the EU Nando website.

UKCA Marking & Conformity assessment for the UK

Medical Devices placed onto the GB market will need to be UKCA marked* and have been subject to Conformity Assessment by a UK Approved Body for Medical Devices.

Eurofins E&E CML Ltd has been designated against the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended) by the MHRA under UKAS No. 8175. For more information, talk to our team or contact our UK Medical Device Certification Team via  EEinfoUK@cpt.eurofinseu.com

*From July 2025, legislative transitional arrangements will apply for CE and UKCA marked Medical Devices and IVDs placed on the Great Britain market. Please contact our UK Medical Device Certification Team for details of the transitional timelines for UKCA/CE Marking. 

Certification for the US & Canada

To access the United States (US) and Canadian markets, medical devices or equipment need to be certified to the specific requirements of those markets.

For the US, this should be undertaken by a Nationally Recognised Testing Laboratory (NRTL) and for Canada, a Standards Council of Canada (SCC) Certification Body.

Eurofins E&E North America is both an NRTL recognised by OSHA and an SCC Certification Body and can provide the MET NRTL mark to demonstrate compliance with the requirements of both of these bodies for medical devices. The MET Mark is universally accepted in both the US and Canada for medical equipment.

FDA Submissions

All medical devices in the United States are regulated by the Food and Drug Administration (FDA) under the Center for Devices and Radiological Health (CDRH).

If you are introducing a new device to the US market, we can help you navigate and support the FDA submission process.

We can also offer expert services to help you gain FDA approval covering Pre-Sub (formerly called Pre-IDE), US FDA 510(k) Premarket Notification submission, “De Novo”, Premarket Approval (PMA) and Accreditation Scheme of Conformity Assessment (ASCA).

The FDA has a permanent program in the Medical Device User Fee Amendments (MDUFA) called “Accreditation Scheme of Conformity Assessment”, or “ASCA”. Medical device manufacturers may voluntarily use an ASCA-accredited testing laboratory to conduct testing to be included in premarket submissions to the FDA.

The program encourages harmonization, expertise, equipment, and accreditation from approved testing laboratories, which streamlines the regulatory submission process.

Eurofins E&E North America has FDA-accredited laboratories to issue ASCA Test Summary Reports incorporating Medical or IVD base, collateral(s), and particular(s) testing per FDA-recognised consensus standards.

CB Scheme

Our Certification Bodies in Germany, Switzerland and the United States are National Certification Bodies (NCB), and the test laboratories are Certification Body Testing Laboratories (CBTL) under the international certification body scheme (CB Scheme).