Be confident of medical device market approval
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).
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:
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.
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.
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:
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:
List B of Annex II contains high-risk products (reagents, calibrators, and controls unless otherwise stated):
Devices for self-testing
These devices are subject to special requirements which are described in Annex I, Section 7 of the IVDD.
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.