EU rules on medical devices

The EU has produced new rules on medical devices to enhance patient safety and modernise public health.

There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Examples of medical devices are contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.

The new Regulations will help to ensure that all medical devices – from heart valves to sticking plasters to artificial hips – are safe and perform well. The new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.

For more information on the new rules about medical devices on the europa.eu website