In Vitro Diagnostic Medical Devices Directive 98/79/EC

WHAT IS IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE (98/79/EC)?

In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). A subgroup of medical products, their market access, use, and market surveillance is regulated. The IVDD is implemented in the national laws of the member states.

The reorganisation of the IVDD with the aim of a reclassification of diagnostics is currently in progress, along with a corresponding update of the common technical specifications. Based upon the results of the public consultation initiated by the Commission in summer 2010, a revision of the IVDD includes modifications of the classification system. This may have consequences for the conformity assessment of single products or product groups.

According to the IVDD, in vitro diagnostic medical devices include: reagents, reagent products, calibration materials, control materials, kits, instruments, apparatus, equipment, and systems that are intended for use in the examination of specimens taken from the human body (tissue, blood, urine, etc.) to diagnose diseases, to monitor a person’s state of health, or to monitor therapeutic procedures.

Examples of in vitro diagnostic medical devices are:

• Hepatitis or HIV tests
• Clinical chemistry
• Coagulation test systems
• Urine test strips
• Pregnancy tests
• Blood sugar monitoring systems for diabetics
• Receptacles manufactured specifically for medical specimens

Accessories for IVDs

Accessories include items that themselves are not in vitro diagnostic medical devices, but are intended for use with those devices. Under the Directive, accessories are treated as separate in vitro diagnostic medical devices.

• Devices for self-testing - Devices for self-testing form a special IVD group. These IVDs are intended by the manufacturer to be used by laypersons in a home environment, for example pregnancy tests.
• Devices for performance evaluation - Devices to be used in performance evaluation studies outside the manufacturer’s facility must also conform to the relevant requirements of the Directive.

Products that are used only for veterinary medicine as well as products for general laboratory use are not subject to the IVD Directive. Sampling devices that are invasive are subject to Directive 93/42/EEC on Medical Devices.

WHO IS IVDD MANUFACTURER?

The IVDD defines the manufacturer as the natural/legal person who is responsible for the design, manufacture, packaging, and labelling of a finished device for the purpose of marketing under his/her own name, regardless of whether these activities are performed by that person him or herself or by a third party acting on his/her behalf.

The manufacturer according to the IVDD will pass on the relevant requirements to suppliers of semi finished products and components. Thus, the suppliers will also be affected by a part of these regulations. Manufacturers of finished IVD products outside the EU must have a representative within the EU.

WHAT ARE IVDD ESSENTIAL REQUIREMENTS?

Annex I of the IVDD requires that the safety and health of patients, users, and any third party must not be endangered by proper use of the product, and that any possible product risk, compared with the associated benefit, is acceptable.

The principle of integrated safety applies, i.e. risk avoidance and risk minimisation in the design and manufacture of the product, protective measures against residual risks, and appropriate information of users. The generally acknowledged state of the art must be applied. The product must be suited for the intended use, and the assigned performance characteristics must be ensured for the lifetime of the product.

In addition to these general requirements, there are other requirements that apply above all to the design and manufacture of the devices and refer to:

• Chemical and physical characteristics (compatibility with the material to be tested)
• Protection against infection and microbial contamination (processing, packaging)
• Suitability for use under the respective environmental conditions (risk minimisation)
• Combination with other products, disposal
• Measurement function (precision, display)
• Protection against radiation (intentional or unintentional radiation, ionising radiation)
• Protection against electric shocks, electromagnetic compatibility
• Protection against mechanical or thermal risks
• Use by laypersons: easy to use, low risk of incorrect interpretation of results (products for self-testing only)
• Provision of information by the manufacturer (labeling, instructions)

WHAT ARE IVDD PRODUCT GROUPS?

The IVDD distinguishes four different groups - based on the risk associated with the use of the respective products. All products in List A and List B require the participation of a Notified Body in all aspects of the conformity assessment procedure.