In vitro diagnostic medical devices

SUMMARY OF:

Directive 98/79/EC on in vitro diagnostic medical devices

SUMMARY

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.

WHAT DOES THE DIRECTIVE DO?

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.

KEY POINTS

• National authorities must ensure that all devices available in the EU are safe when they are supplied, properly installed, maintained and used as they should be.
• The devices must meet essential safety requirements in their design and other characteristics.
• Devices which meet these standards are given a CE marking and can be used throughout the EU.
• 2 committees — one on standards and technical regulations, the other on medical devices* — provide advice to the Commission on implementation of the legislation.
• National authorities must take off the market any devices which are later found to harm people’s health.
• They must immediately explain to the Commission the reasons for their decision. Other EU governments are kept informed.
• The New Approach Notified and Designated Organisations (NANDO) Information System contains details of the national bodies that check the devices meet EU standards.

KEY TERMS

* 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.

BACKGROUND

• Regulatory framework
• In vitro diagnostic medical devices
• Communication from the Commission — Guidelines on COVID-19 in vitro diagnostic tests and their performance

ACT

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

RELATED ACTS

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