Medical Devices Regulation (EU)

The new EU Medical Devices Regulation 2017/745 (MDR) applies from (yesterday) 26 May, after a year’s postponement. The MDR is here.

The MDR tightens 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.

The new 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. Labelling will be more detailed and electronic manuals will increase user-friendliness. Implant patients will receive an implant card with all the essential information.

Once devices are available on the market, manufacturers will have to collect data about the devices’ performance. EU countries will closely coordinate their vigilance and market surveillance.

The MDR is complemented by the Regulation on in vitro diagnostic medical devices (2017/746/EU) which applies a year later on 26 May 2022.

Q&A about the MDR is here.

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