UNDERSTANDING THE 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 Commission of the European Union (EU) is currently developing a revised regulation that addresses the requirements for in vitro diagnostic medical devices offered for sale in the EU. Once adopted, the new regulation will replace the EU’s Directive on in vitro diagnostic medical devices (98/79/EC).
WHAT ARE IN VITRO DIAGNOSTIC (IVD) MEDICAL DEVICES?
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 IVD DEVICES
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 A 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.
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)
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.
List A of Annex II contains the products with the highest potential risk. They include reagents, calibrators, and controls for the determination of:
- Blood groups (ABO system, rhesus, anti-Kell)
- HIV-1/-2 infections, HTLV-I/-II infections, and hepatitis B, C, and D
List B of Annex II contains high-risk products (reagents, calibrators, and controls unless otherwise stated):
- For the determination of blood groups (anti-Duffy and anti-Kidd);
- For determination of irregular anti-erythrocytic antibodies;
- For the detection of rubella and toxoplasmosis;
- For the detection of phenylketonuria;
- For the detection of infections with cytomegalovirus or chlamydia;
- For the detection of the tumor marker PSA;
- For the determination of HLA tissue types DR, A, B;
- For the evaluation of the risk of trisomy 21, including software;
- Products for self-diagnosis of blood sugar levels, including instruments.
Devices for self-testing
These devices are subject to special requirements which are described in Annex I, Section 7 of the IVDD.
- The product must be easy to use for laypersons, and the enclosed instructions must be easy to understand.
- The risk of errors in use or in the interpretation of results must be kept as low as possible.
- Where possible, such devices must include a user control which allows verification of correct performance at the time of use.
Devices for self-testing require the participation of a Notified Body in the conformity assessment procedure. The aspect of self-testing is of special interest in the evaluation by the Notified Body.
Note: Products for determining blood sugar levels are exempted from this device group (see List B).
Other IVD products
Products that are neither listed in Annex II nor intended for self-testing do not require involvement of a Notified Body in the conformity assessment procedure. Typical examples are clinical chemistry tests or tests for thyroid function.