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Medical Products

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Eurofins has been named a certification authority for the EU Medical Device Directive(93/42/EEC), and can issue the following types of certification and declarations:

  • EC Type-Examination Certification (Annex III)
  • EC Verification Certification (Annex IV)
  • EC Declaration of Conformity

Our certification services include the following products(excluding Class III products):

1. Annex III and Annex IV

2. Annex V and annex VI

  • Nonresorbable Surgical Implants
  • All Class I Disinfection Equipment
  • Transfusion, Blood Transfusion, Injection, Sampling and
  • Cardiopulmonary Bypass Equipment
  • Ophthalmic Equipment
  • Disinfectants and Preservatives
  • Contact Lens Care Products
  • Non-absorbable Material for Sutures and Clamps
  • Disposable Products
  • Drug Treatment Material
  • Dental Equipment, Materials and Facilities
  • Surgical Equipment
  • Medical Gloves
  • Contraceptive Devices
  • Anesthesia Ventilators
  • Catheters, Drains and Probes
  • Reusable Equipment
  • Enteral and Parenteral Care Equipment

We provide efficient, quality services to help customers achieve the following objectives:

  • Help customers ensure safe and effective products offering reproducibility and quality control
  • Ensure innovation without sacrificing product safety
  • Ensure that product designers and manufacturers can communicate with professional experts and laboratories to perform proper risk assessment and testing to verify the product

In order to ensure utmost fairness while achieving these goals, we are committed to:

  • Strict confidentiality and impartiality
  • Allowing inspectors and experts to choose carefully
  • Ensuring maximum openness and transparency when Committee members are involved in the certification decision-making process