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In-Vitro Diagnostics

MedNet as your Authorized Representative for in-vitro diagnostics acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the In-Vitro Diagnostic Medical Devices Directive (98/79/EC) as well as additional services regarding the marketing of your in-vitro diagnostics within the European Community.

MedNet Services for In Vitro-Diagnostics

  • fast product registrations to EU Competent Authorities
  • guidance in the preparation of Declarations of Conformity
  • guidance in the labeling and language requirements in Europe
  • Incident reporting to the competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state
  • notification services for clinical investigations
  • application of Free Sales Certificates / Certificates of Marketability
  • preparation of Certificates of product registration

What is an In-Vitro Diagnostic Medical Device?

According to the In-Vitro Diagnostic Device Directive IVDD 98/79/EC an 'in-vitro diagnostic medical device` is defined as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • concerning a physiological or pathological state, or
  • concerning a congenital abnormality, or
  • to determine the safety and compatibility with potential recipients, or
  • to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. 'Specimen receptacles` are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in-vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in-vitro diagnostic examination.

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