The European Parliament approved the new Regulations relating to medical device and IVD last April 5.
The Regulations measures will be more severe and stringent than before avoiding past mistakes, like defective silicone gel breast implants and unreliable HIV test, will be committed in the future.
The Regulations introduce many new features, including: efficient post- market surveillance; random inspections of manufacturers carried out by Notified Bodies even after the device marketing; additional safety procedure on high risk devices carried out by Notified Bodies and an expert commission; “implant card” which allowed to patients and clinician to monitoring the product implanted; clinical evidence relating to the safety of higher risk Classes Medical Devices.
The Regulations will be published in early May in the Official Journal and will entry into force in early June. Afterward, there will be a transitional period of three years for the medical device Regulation and five year for IVD Regulation.
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