New EU rules on medical devices to enhance patient safety and modernise public health

 

“Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. The new rules will also cover certain, previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision). In addition, a new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices.” by European Comission

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