A REVIEW ON EUROPEAN UNION NEW MEDICAL DEVICE REGULATIONS-2017
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ABOUT AUTHORS
U.Swathi lakshmi1, K.Revathi1 , Dr.P.Shailaja1, Prof.J.Vijaya Ratna1, Blessy A. Daniel2, Dr.Prashanth.S.2
1Andhra University College of Pharmaceutical Sciences, Visakhapatnam
2S3V Vascular technologies Pvt.Ltd, Bangalore
ABSTRACT:
The New Medical Device Regulations of European Union replace the E.U’s current Medical Device Directive (93/42/EEC) and the E.U’s Directive on Active Implantable Medical Devices (90/385/EEC) According to the draft document, NB’s would be placed under a strict regimen of super vision, although it remains unclear whether the intended sanctions could be implemented against the will of a Member State, should the need occur. The qualification requirements for auditing and reviewing NB staff are steeply increased. Greater emphasis will be placed on clinical data and the Clinical Evaluation. For implantable medical devices and Class III devices clinical investigations will be expected since equivalence will generally no longer be an acceptable approach, although some exceptions can be made. The proposed MDR attempts to make more transparent the periods for review by various parties for different activities. Implementation of Unique device identification helpful for the unambiguous identification of a specific device on the market.
