Medical devices make an essential contribution to healthcare in the EU for the benefit of European citizens. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic devices that monitor diabetes or identify infections; medical devices are crucial in diagnosing, preventing, monitoring and treating illness, and overcoming disabilities. They are also important to the economy, providing €110 billion in sales and 675,000 jobs in Europe. The EU is a net exporter in this sector.
We are transferring the medical devices topic to the European Commission's Directorate-General for Health and Food Safety. We will place new information on their public health website. Therefore, you may find overlapping information between their website and ours for a short period.
With patient health and safety as a guiding principle, the Council and the Parliament adopted Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions on 23 April. This Regulation enters into force on the day of its publication in the Official Journal of the European Union and postpones the date of application for most MDR provisions by one year. 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 In Vitro Diagnostic Medical Devices Regulation's (IVDR, Regulation (EU) 2017/746) corresponding date of application remains the same (May 2022).
European legislation 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 European regulations are replacing 3 existing directives in the years up to 2022.
Whether you are a manufacturer, an authorised representative, an importer, a distributor, a user or a health professional, this website will tell you what you need to know about the new regulations and how they will enhance the quality of medical devices on the European market for the benefit of all.
Medical devices play an essential role in the healthcare of EU citizens. Diversity and innovation in the medical devices sector contribute significantly to enhancing the safety, quality and efficacy of healthcare in the EU.
The medical devices sector helps save lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, treatment and alleviation of disease. The sector has become increasingly important for the healthcare of EU citizens and as an influencer of health expenditure.
The medical devices sector faces many challenges at national, European and international levels. These challenges can harm the competitiveness of the sector, yet if correctly addressed they also have the potential to promote innovation
Enhancing competitiveness while ensuring the safety and efficacy 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.
The 2 regulations establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. This, in turn, will boost confidence in our medical devices industry.
Medical devices within the EU are currently regulated by 3 directives:
On 5 April 2017, 2 new regulations on medical devices and in vitro diagnostic medical devices were adopted. They entered into force on 25 May 2017 and will progressively replace the existing directives. The new regulations will be fully applicable in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
The Commission welcomes the adoption of these 2 regulations, which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. This in turn will boost confidence in our medical devices industry.