Certification of IVD device

Certification of IVD device and compliance audit according to 98/79/EC directive

About in vitro diagnostic devices (IVD)

Definition of in vitro diagnostic device according to 98/79/EC directive:

“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.

The directive contains other important definitions, as:

‘accessory` means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.

For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;.

‘device for self-testing` means any device intended by the manufacturer to be able to be used by lay persons in a home environment;

‘device for performance evaluation` means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises.

This directive do not consider to be medical device the following:

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.

Knowing 93/42/EEC and 98/79/EC directives, manufacturer can judge if the product is in vitro diagnostic medical device or not. Decision depends on the intended use of the device.

CE marking (IVD)

If a manufacturer would like to market its in vitro diagnostic device within the EU, product needs to dispone with CE marking, except the device is for performance evaluation.

Official definition of CE marking is as follows:

By affixing the CE marking to a product, a manufacturer declares that the product meets all the concerned requirements and legal requirements for CE marking and can be sold throughout the EEA.

Device can be marketed or put in operation only if it complies with the basic requirements of directives concerned, it is properly fixed, located, maintained and it is used according to its intended purpose.

CE marking is licence for admission to European market, thus if manufacturer would like to market its product within the EU, it must possess CE marking. CE marking assures, that conformity of product is proven with conformity assessment procedures which investigates conformity of basic requirements of concerning directions, but it is not directly means that product has been manufactured within the European Economic Area.

It is always manufacturer’s responsibility to perform conformity assessment procedure, edit documents regarding product, fill out Declaration of Conformity and place CE marking on product.

Main steps of conformity assessment procedure:

· decide whether product is in vitro diagnostic device or not

· choosing suitable conformity assessment procedure taking into consideration the type of in vitro diagnostic device to prove, that product meets the requirements of 98/79/EC directive

· after choosing the procedure, manufacturer or European authorized representative has to realize it, including a Notified Body, if needed

· in case of proven conformity, CE marking has to be put on product. Manufacturer may choose among conformity assessment procedures, what are defined in 98/79/EC directive.