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 devices¹. 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 devices² — 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.

In vitro diagnostic medical devices

SUMMARY

WHAT DOES THE DIRECTIVE DO?

KEY POINTS

KEY TERMS

BACKGROUND

ACT

SUMMARY

WHAT DOES THE DIRECTIVE DO?

KEY POINTS

KEY TERMS

BACKGROUND

ACT

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