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IVDD Introduction

In Vitro Diagnostic (IVD) medical devices are regulated by a third EC Medical Device Directive, the IVD medical device Directive 98/79/EC, which has been mandatory in Europe since December 2003. The Common Technical Specifications (CTS) provide the conformity requirements for List A devices. Notified Body certification is required for all List A, List B and Self Test devices.

“in vitro diagnostic medical device” means 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;

The scope of the IVD Directive is the specific category of in vitro diagnostic medical devices as defined in the directive. IVD devices are classified by use of a definitive listing, not classification rules. Annex II of the Directive identifies certain devices as List A (high risk e.g. HIV test kits) or List B (medium risk e.g. blood glucose meters), both of which require Notified Body certification. Further special requirements apply to Self Test devices (for lay persons e.g. pregnancy test kit), also requiring Notified Body certification. All other low risk general IVD devices are usually referred to as “non-Annex II” and do not need Notified Body certification.

Manufacturers new to CE marking should seek advice on classification at an early stage.

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