New EU rules on medical devices into force
Medical devices
(BRUSSELS) - New EU rules on medical devices entered into application on Wednesday, with the aim of establishing a modern and more robust regulatory framework to protect public health and patient safety.
The Medical Devices Regulation (MDR) starts applying after a one-year postponement due to the unprecedented challenges of the coronavirus pandemic, and addresses the need for an increased availability of vitally important medical devices across the EU.
The Regulation covers medical devices ranging from hip replacements to sticking plasters. There are over 500,000 types of medical devices on the EU market. Other examples of medical devices are contact lenses, x-ray machines, ventilators, pacemakers, software, breast implants, hip replacements and sticking plasters.
The rules increase transparency and bring EU legislation in line with technological advances and progress in medical science. It improves clinical safety and creates fair market access for manufacturers.
"The new rules improve the safety and quality of medical devices while providing more transparency for patients and less administrative burden for businesses," said Health Commissioner Stella Kyriakides: "The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges."
In summary, the Medical Devices Regulation:
- Improves the quality, safety and reliability of medical devices: it imposes tighter controls on high-risk devices such as implants and requires the consultation of a pool of EU level experts before placing medical devices on the market. Clinical evaluations, investigations and the notified bodies that approve the certification of medical devices will be subject to tighter controls.
- Strengthens transparency and information for patients, so that vital information is easy to find. The European database of medical devices (EUDAMED), will contain information about each medical device on the market, including economic operators and certificates issued by notified bodies. Each device will have a unique device identifier so that it can be found in EUDAMED. More detailed labelling and electronic manuals will increase user-friendliness. Implant patients will receive an implant card with all the essential information.
- Enhances vigilance and market surveillance:Once devices are available on the market, manufacturers have to collect data about the devices' performance. EU countries will closely coordinate their vigilance and market surveillance.
Application of Regulation on Medical Devices - EU rules for safety of medical devices - guide