Notified Body Services

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Eurofins E&E Notified Body (EU) Certification Services

To gain regulatory authority approvals for medical electrical devices, equipment manufacturers must prove their products comply technically and administratively with relevant standards and gain the necessary certifications.

Different global regions and countries have different regulatory and certification requirements. Gaining them can prove costly and time consuming. Eurofins E&E Notified Body (EU) Certification Services

Eurofins E&E North America can help you earn the certifications you need to bring your Electrical Medical Devices to the European market.

Medical Device Certification for the EU Market

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, Eurofins E&E has a number of Notified Bodies (NB) that can provide conformity assessment to the Medical Device Regulation (MDR) 2017/745 as well as to the In-Vitro Diagnostic Regulation (IVDR) 2017/746.

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.

Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Our certification body in Finland (NB No. 0537) is a Notified Body under the IVDR (2017/746) for in vitro medical devices.

Medical Device Directive (MDD) 93/42/EEC

Our certification bodies in Finland (NB No. 0537) and Italy (NB No. 0477) are Notified Bodies under directive 93/42/EEC for both active and non-active medical devices.

In Vitro Diagnostic Devices to the IVD Directive (98/79/EC)

For in vitro diagnostic medical devices, our certification body in Finland is a Notified Body (NB No. 0537) under the IVD Directive (97/79/EC).

Why Choose Us?

We provide testing and notified body services through our worldwide network of Eurofins Electrical & Electronic (E&E) laboratories.

By working with Eurofins E&E North America, you get:

Efficient and easy access to Global Markets
Access to the European market through our Notified Body services
Access to the U.S. market through our NRTL services and FDA expert services
Access to Canada through our SCC services
Certification for your product through the CB Scheme for compliance in more than 50 countries