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 Directives
In order to bring medical devices to the European (EU) market, manufacturers must earn a CE Mark to confirm compliance with the Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC.
These CE marking Directives cover active medical electrical equipment and are classified according to the potential risks associated with the device. Most device classifications require both accredited testing and Notified Body services in order to gain the necessary market approvals.
Eurofins E&E Notified Body (EU) Certification Services utilizes the Eurofins medical device testing network, which operates as a Notified Body authorized to issue EC certifications in accordance with the appropriate CE marking Directive, MDD 93/42/EEC or IVDD 98/79/EC:
- Class II active medical electrical equipment and non-active medical devices
- Class III medical devices classified as containing a medical substance and/or use tissue of animal origin
- In vitro diagnostic medical devices, IVDD Annex II devices and devices for self-testing
Through Eurofins, you can obtain:
- EC Type Examination certificates (MDD, Annex III)
- EC Verification certificates (MDD, Annex IV)
- EC Declaration of Conformity – Production quality assurance (MDD, Annex V)
- EC Declaration of Conformity – Product quality assurance (MDD, Annex VI)
- EC Declaration of Conformity – Full quality assurance system (Annex II)
- EC Declaration of Conformity – Design examination (IVDD, Annex III)
- EC Declaration of Conformity – Full quality assurance system (IVDD, Annex IV)
Eurofins has three designated notified bodies—n.0477, n.0537 and n.0681—for CE certification in accordance to 93/42/EEC Directive, and one under 98/79/EC for in-vitro diagnostic medical devices directive.
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