WHAT IS EU MDR?
The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to have a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, EU MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation.
EU MDR is relevant to any organization producing or supplying medical device products to Europe.
See how we can help with EU MDR Implementation.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
