Notified Body Services
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. To assist you in placing your medical devices onto the EU market, Eurofins E&E has a number of Notified Bodies (NB) who can provide conformity assessment to:
Medical Device Regulation 2017/745
Medical Device Directive 93/42/EEC
IVD Directive 98/79/EC
Medical Device Regulation (MDR) 2017/745
Our certification body in Finland (NB No. 0537) is a Notified Body under the MDR (2017/745) for both active and non-active medical devices.
Medical Device Directive (MDD) 93/42/EEC
Our certification bodies in Finland (NB No. 0537), Germany (NB No. 0681) 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