The Regulation: MDR 2017/745
Regulation (EU) 2017/745 (Medical Device Regulation – MDR) has been adopted on the 5th April 2017. It will apply to medical devices and their accessories after the transitional period of 3 years (May 2020).
The regulation sets essential health and safety requirements, while additional common specification and delegated acts will be drawn up at a later stage by the Commission. These specifications shall be taken into account by manufacturers as well as Notified Bodies. These Common Specifications will exist in parallel to the Harmonized Standards and the State of the Art.
Medical devices scope has been widened to include aesthetic purpose.
Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients.
Manufacturers shall establish, implement, document and maintain a risk management system, and eliminate or reduce risks as far as possible through safe design and manufacture.
Manufacturer shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with the Regulation in the most effective manner and in a manner which is proportional to the risk class and the type of device.
CE marking shall be affixed on devices complying with the MDR. Devices will freely circulate in the European Economic Area and Switzerland provided that the manufacturer will continue complying with their obligations under the MDR and that the devices are safe.