In vitro diagnostic medical devices
This directive aims to ensure the free movement of in vitro diagnostic devices. It harmonises the national laws on the reliability of these products and on the protection of the health and safety of patients, users and third parties.
The Directive applies to in vitro diagnostic medical devices and their accessories.
These devices are products used for the in vitro analysis of tissues or substances (blood, specimens) from the human body. The types of analysis covered are as follows:
- state of health;
- congenital diseases or anomalies;
- checking the progress of courses of treatment;
- determining compatibility in the case of organ or blood donations.
The Directive lays down the objectives or "essential requirements" of safety, health, design and manufacture which must be met by in vitro diagnostic medical devices when they are manufactured and placed on the market.
These devices must achieve the performances intended by the manufacturer. They must be designed in such a way as to withstand the storage and transport conditions.
Member States shall publish the national standards implementing the corresponding harmonised standards, which shall also include the monographs of the European Pharmacopoiea. Any product manufactured in accordance with harmonised standards is presumed to conform to the essential requirements.
All devices must be subjected to a conformity assessment procedure. Member States shall designate independent bodies contributing to the application of these procedures for devices other than those which represent a minimal risk.
Placing on the market and free movement
Member States shall take necessary steps to ensure that devices may be placed on the market and put into service only if they meet the requirements of this Directive and do not compromise the safety and health of patients, users and other persons when properly implanted, maintained and used in accordance with their intended purposes.
Member States not must not impede the placing on the market, free movement and putting into service of devices meeting the essential safety criteria set out in the annexes to the Directive and bearing the CE mark.
The aim of the European databank is to store the data required by law. The latter shall be made available to the competent authorities and shall contain:
- data on registration of manufacturers;
- data relating to certificates issued, amended, suspended, withdrawn or refused;
- data obtained in accordance with the vigilance procedure;
- data on clinical investigations.
The manufacturer must immediately inform the competent authorities of any incident causing death or damage to the health of a patient, by applying the procedures of a technico-vigilance system. This information must be recorded and evaluated by Member States.
Notified bodies shall be authorised to carry out inspections of manufacturers. For their part, manufacturers must provide the inspectors with all relevant information.
Member States must take all appropriate measures to withdraw from the market devices conforming to the Directive which are liable to compromise the health and/or safety of patients, users or third parties. The provisional measures taken must be notified to the Commission.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
OJ L 331 of 7.12.1998
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1882/2003||
OJ L 284 of 31.10.2003
|Regulation (EC) No 596/2009||
OJ L 188 of 18.7.2009
Successive amendments and corrections successives to Directive 98/79/EC have been incorporated into the basic text. This consolidated version is for information only.