EU information and factsheet for manufacturers

Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

The EU has a competitive and innovative medical devices sector, characterised by the active role of small and medium-sized enterprises. It is supported by a regulatory framework that aims to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users.

There are over 500 000 types of medical devices and IVDs on the EU market. Examples of medical devices are sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. IVDs are used to perform tests on samples, and examples include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.

The medical devices sector is essential to the provision of healthcare to citizens and is an important player in both the European and global economy.

Legislation

The European regulatory framework ensures the safety and efficacy of medical devices and facilitates patients’ access to devices in the European market.

To keep up with advances in science and technology, 2 new Regulations are replacing the 3 existing Directives in the coming years (until 2022).

Medical devices within the EU are currently regulated by 1 Regulation and 3 Directives:

• Regulation (EU) 2017/745 on medical devices (MDR)
• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
• Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
• Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVDMD)

On 5 April 2017, 2 new Regulations on medical devices and in vitro diagnostic medical devices establishing a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety were adopted.

They entered into force on 25 May 2017 and will progressively replace the existing directives after a transition period.

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU