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Notified Body Services

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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.

We work with product designers and manufacturers to perform risk evaluations and necessary assays in order to certify the product.

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)

Certifications Offered:

  • 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).