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Eurofins Product Testing - Medical Devices

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Eurofins operates a Notified Body authorised to award EC certification (ON n. 0477) of Medical Devices in accordance with Directive 93/42/EEC

  • Type examination certificates (annex III): EC certificate showing conformity of the Medical Device examined (type) with the essential requirements established in the directive

  • EC verification certificates (annex IV): the EC certificate that guarantees and declares that the production batch(statistical verification) or each product (individual verification) conforms to the type certified and to the applicable requirements of the directive
  • EC declaration of conformity - guarantee of quality of the manufacturing process or of the product (annexes V-VI), limited solely to performance factors designed to secure and maintain sterility, the certificate that guarantees and declares that the quality system, with regard to sterility, is applied and complies with the requirements of the directive.

Eurofins certification authority covers the following products (except Class III products):

  • Annex III and Annex IV

    • non-absorbable surgical implants
    • devices for infusion, transfusion, injection, taking samples, extracorporal
    • circuits ophthalmic devices
    • disinfectants and antiseptics
    • products for the care and maintenance of contact lenses
    • non-absorbable materials for suture and clamps
    • single-use products
    • medication materials
    • devices, materials and equipment for use in the dental sector
    • surgical equipment
    • gloves for medical use
    • contraceptive devices
    • devices for anaesthesia and ventilation
    • catheters, drains and probes
    • reusable devices
    • devices for enteral and parenteral nutrition
  • Annex V and Annex VI

    • all Class I sterile products

Eurofins offers efficient, qualified service with the following objectives:

  • to help customers obtain products that are both very safe and highly functional, offering reproducible and controlled quality
  • to ensure that product innovations are permitted as long as they do not prejudice its safety

  • to ensure that the product designer and the manufacturer can contact qualified experts and laboratories to make correct risk evaluation and do the assays necessary to certify the product.

To achieve these goals with the greatest possible impartiality, Eurofins commits itself to:

  • maintain strict confidentiality and impartiality
  • make a careful selection of inspectors and experts
  • maximum openness and clarity in the decision-making process, involving the members of the CertificationCommittee in the decisions of the Notified Body.

Contact a Medical Devices expert today !

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Our certification staff is pleased to advise you in all certification questions:

Germany

Tel. +49 33631 888 801
 ProductTesting-BLN@eurofins.com

Italy

Tel. +39 335 7470 287
 ProductTesting-TO@eurofins.com