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.
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.
Before MedNet can act as your European Authorized Representative, the manufacturer must complete the following steps:
- The product compliance must be ensured
- The product must be classified
- A Notified Body involved (for products covered by Annex II of the in-vitro diagnostic directive IVDD 98/79/EC) and Declaration of Conformity prepared
- A CE mark affixed and labeling completed
- The Authorized Representative must be included in the manufacturer’s product liability insurance