Medical Devices
Medical Devices
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.
Highlights
- EUDAMED device data elements' registration timeline
- EUDAMED legacy devices' registration
- Interpretation of MDR article 54(2)b
- Field safety notice template and supporting documents are online
- Updated MDR and IVDR implementing measures rolling plan is online
- Stakeholder engagement toolkit in multiple languages is online
- Updated library of external resources and websites is online
- Further guidance: regulation of medical devices if there’s no Brexit deal
- Using the UKCA marking if the UK leaves the EU without a deal
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Get ready
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.
About medical devices
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 importance of the medical devices sector
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.
Challenges facing the sector
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
- Public health systems
- Challenges in public health systems include new and emerging needs such as developing a shared understanding of healthcare goals, overcoming health inequalities, looking after an ageing society, and exploiting the potential of e-health technologies.
- Balancing patient needs and financial sustainability
- Healthcare is costly. We need to ensure that patients get better access to medical devices at costs that are affordable to the healthcare systems of EU countries.
- Competitiveness and innovation
- The medical devices sector faces challenges in research and development, emerging technologies, the green economy, and in relation to the EU’s cooperation with the rest of the world on trade and regulatory matters. SMEs face particular challenges in this regard.
What the Commission is doing
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.
Regulatory framework
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.
Current Directives on medical devices
Medical devices within the EU are currently regulated by 3 directives:
- Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
- Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
- Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)
New Regulations on medical devices
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.