Ranging from simple sticking plasters and contact lenses to sophisticated pacemakers and hip replacements, medical devices and in vitro medical devices are important to our health and quality of life. Almost everyone will use a medical device at some time in their life - be it a sticking plaster after falling off a bike or a hip replacement when our joints wear out.
People rely on these devices every day and expect them to be safe. EU rules have helped to ensure that safety for over twenty years, but it is time to bring them up to date.
On 5 October 2015, the Ministers of the EU countries agreed on a general approach on the medical devices package that has been discussed for almost for three years. This agreement is a major step forward towards the adoption of new regulations on medical devices to help guarantee a high level of health and safety protection for EU citizens using these products.
Why do we need new regulations on medical devices?
The scandal involving fraudulent breast implants and problems with some metal-on-metal hip replacements damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened.
To make that happen, the Commission proposed updated Regulations on medical devices and in vitro medical devices in 2012. The proposals significantly tighten the controls to ensure that medical devices are safe and effective. At the same time, they foster innovation and improve the competitiveness of the medical device sector. The new rules are more transparent and better adapted to scientific and technological progress made in the past years.
After three years of discussions at expert level, the ministers of all EU countries on 5 October 2015 agreed on the general approach to the medical devices package. This is a significant move on the way to the adoption of the two Regulations and to help patients and health care professionals reap the benefits of safe, effective and innovative medical devices in the near future.
The general approach will serve as a basis for the informal three-way discussion between the European Parliament, The Council and the European Commission.
- Regulations relating to the safety and performance of medical devices in the EU were harmonised in the 1990s. The EU legislation needs to be adapted to the significant technological and scientific progress in this sector over the last 20 years to guarantee high levels of health and safety protection for EU citizens using these products.
- The revisions affects home-use items such as sticking plasters, pregnancy tests and contact lenses, as well as others such as x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
- The medical devices industry is a major employer in Europe, employing 575 000 people in the EU. The sector represents some 25 000 companies, of which 95% are small and medium-sized enterprises (SMEs). Total sales amount to €100 billion.