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.
As a sector experiencing continuous and rapid development, ensuring a sustainable set of regulations that guarantees safety but also innovation may pose certain challenges at national, European, and international levels.
- Public health systems
- EU public health systems need to adapt in order to face new and emerging needs, which requires the development of a shared understanding of healthcare goals to overcome inequalities and look after an ageing society
- Access to healthcare
- As access to healthcare can be costly, both to the patient and to the national health systems, the EU needs to ensure that patients get better access to medical devices at affordable prices
- Sustaining innovation
- In order to foster innovation, it is necessary to adapt research and development to emerging scientific and technological progress and to move towards a circular and green economy, whilst maintaining competitiveness
What is the European Commission doing?
Enhancing competitiveness while ensuring the safety and performance of medical devices is a key objective of the European Commission. To achieve this, the Commission regularly liaises with patient and industry associations to explore ways of bringing innovation to patients while helping enterprises and maintaining growth.
A number of publications are available to inform and support the industry in improving competitiveness.
- Notice to Stakeholders: Withdrawal of the UK and EU rules for medicinal products for human use and veterinary products
- The European Union and the United Kingdom – forging a new partnership
- Getting ready for the end of the transition period
- Notice to stakeholders - Industrial products