The Directive: IVDD 98/79/EC
IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own dedicated set of requirements for manufacturers wishing to place medical devices in the European Economic Area. The Directive sets out device classification rules, requirements for both devices and manufactures placing them on the market, ensuring safety and quality of these products.
Under the IVDD 98/79/EC, an In-Vitro Diagnostic Medical Device is defined as:
“any medical device which is a reagent, reagent device, 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 state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
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