Getting ready for the new regulations for 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.
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.
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:
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.
More info: https://ec.europa.eu/growth/sectors/medical-devices_en
