This document is an excerpt from the EUR-Lex website
Document 01998L0079-20120111
In vitro diagnostic medical devices
Directive 98/79/EC on in vitro diagnostic medical devices
The directive aims to guarantee the smooth operation of the single market by harmonising different national legislation on the reliability of in vitro diagnostic devices*. It provides a high level of protection for the health and safety of patients, users and others and ensures the devices achieve the results for which they are intended.
It sets out the essential safety, health, design and manufacturing requirements that in vitro diagnostic medical devices and their accessories must meet. This ensures universally high safety standards, giving the public confidence in the system. It enables the products to be used in any European Union country.
* Medical devices: appliances, including the necessary software, used to diagnose, prevent, monitor, treat or alleviate disease or injury; to diagnose, monitor, treat, alleviate or compensate an injury or handicap, to investigate, replace or modify the human body or a physiological process; or as a contraceptive.
* In vitro diagnostic medical device: medical devices, such as reagents, calibrators, control material test tubes, to perform a diagnostic test, like checking blood for signs of infections or urine for the presence of glucose, using material from the human body.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Act |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Directive 98/79/EC |
7.12.1998 |
7.12.1999 |
Amending act(s) |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Regulation (EC) No 1882/2003 |
20.11.2003 |
- |
|
Regulation (EC) No 596/2009 |
7.8.2009 |
- |
Successive amendments and corrections to Directive 98/79/EC have been incorporated into the basic text. This consolidated version is for information only
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, pp. 17–30). See consolidated version
Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (OJ L 253, 25.9.2013, pp. 27–35)
Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation) (OJ C 14, 16.1.2015, pp. 74–79)
last update 10.06.2020