Until now, different European countries have interpreted and implemented the directive in different ways. By revising the directive EU MDR will enforce:
Stricter pre-market control of high-risk devices at an EU level
The inclusion of certain aesthetic products which present the same characteristics and risk profile as equivalent medical devices
A new risk classification system for diagnostic medical devices based on international guidance
Improved transparency through the establishment of a comprehensive EU database of medical devices (Eudamed)
Device traceability through the supply chain from its manufacturer through to the final user
An EU-wide requirement for an 'implant card' to be provided to patients containing information about implanted medical devices
the reinforcement of the rules on clinical data and clinical studies on devices
Manufacturers to collect data about the real-life use of their devices
Improved coordination between EU Member States
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
