MDD - IVD: Need of CE Marking

As non-European Medical Devices Manufacturers exporting to Europe, do your products require CE-Marking? It is left up to the Manufacturer to determine the applicability of the Directives to their product as well as the product classification. Determining whether your product needs CE Marking or not requires some familiarity with the European Directive’s definition of MDD/IVD/AIMD Devices.

All MDD/IVD Devices can only be considered as such if the following requirements are fulfilled:

MEDICAL DEVICE means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

Diagnosis, prevention, monitoring, treatment or alleviation of disease.
Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.

*Investigation, replacement or modification of the anatomy or of a physical process, Control of conception And which does not achieve its principal action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

All In Vitro Diagnostic Devices are first classified as a Medical Device, then fall under the In Vitro Diagnostic Device definition.

IN VITRO DIAGNOSTIC 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.

PLEASE NOTE:

Products intended for use in the in vitro examination of human specimens solely for legal, military or other non-medical purposes are not in vitro diagnostic medical devices. Devices intended to be used in the course of law enforcement for detecting illegal drugs in the traffic or elsewhere are not IVD medical devices, if they have no intended purpose in medical setting (e.g. the diagnosis of drug intoxification). This intended purpose in medical setting should be clearly indicated in the ‘intended use’ of the kit insert, if put on the market as IVD medical devices.
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 (unless specifically intended by their manufacturer to be used for in vitro diagnostic examination) are not in vitro diagnostic medical devices.
Medicines are not medical devices/ in vitro diagnostic devices.

For information on how to obtain CE Marking for your product(s), see our General Steps page for MDD and IVD Devices. Obelis European Authorized Representative assist’s you in determining if your products require CE Marking as well as steps tailored to your company’s product(s).

Last updated Dec 27, 2008

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