Notified Body Services
In order to legally sell products in the EU market, medical device manufacturers must earn a CE mark to confirm compliance with the Medical Device Directive 93/42/EEC and supplementary Directive 2007/47/EC (MDD) to be classified according to potential risks associated ( Class I, II and III products).
Eurofins Medical Device Testing operates a Notified Body authorized to award EC certification (NB n.0477) for active and non-active medical devices in accordance with Directive 93/42/EEC to help clients obtain products that are safe and highly functional, offering reproducible and controlled quality.
Choose Eurofins Medical Device Testing to help you earn:
✔ EC Type Examination certificates (Annex III)
✔ EC Verification certificates (Annex IV)
✔ EC Declaration of Conformity – Production quality assurance (Annex V)
✔ EC Declaration of Conformity – Product quality assurance (Annex VI)
✔ EC Declaration of Conformity – Full quality assurance system (Annex II)
- Notified Body n° 0477 for CE certification in accordance to 93/42/EEC Directive, both for Active and Non-Active Medical Devices
- Certification Body n° 133A according to ISO 13485 Scheme (Quality Management System for Medical Devices).