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.
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
|With patient health and safety as a guiding principle, the Council and the Parliament adopted on 23 April 2020 Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions. This Regulation postpones the date of application for most Medical Devices Regulation provisions by one year – until 26 May 2021. This postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.|
The IVDR Regulation (EU) 2017/746) corresponding date of application remains the same (May 2022).
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