A Review on European Union New Medical Device Regulations-2017

  • U.Swathi lakshmi Andhra University College of Pharmaceutical Sciences
  • K Sowjanya Andhra University College of Pharmaceutical Sciences
  • K Revathi Andhra University College of Pharmaceutical Science
  • P Shailaja Andhra University College of Pharmaceutical Sciences
  • J.Vijaya Ratna Andhra University College of Pharmaceutical Sciences
  • Blessy A Daniel S3V Vascular technologies Pvt.Ltd
  • S Prashanth S3V Vascular technologies Pvt.Ltd
Keywords: European Union, Medical Device, regulations

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.

Author Biographies

U.Swathi lakshmi, Andhra University College of Pharmaceutical Sciences

Andhra University College of Pharmaceutical Sciences,
Visakhapatnam, India

K Sowjanya, Andhra University College of Pharmaceutical Sciences

Andhra University College of Pharmaceutical Sciences,
Visakhapatnam, India

K Revathi, Andhra University College of Pharmaceutical Science

Andhra University College of Pharmaceutical Sciences,
Visakhapatnam, India

P Shailaja, Andhra University College of Pharmaceutical Sciences

Andhra University College of Pharmaceutical Sciences,
Visakhapatnam, India

J.Vijaya Ratna, Andhra University College of Pharmaceutical Sciences

Andhra University College of Pharmaceutical Sciences,
Visakhapatnam, India

Blessy A Daniel, S3V Vascular technologies Pvt.Ltd

S3V Vascular technologies Pvt.Ltd,
Bangalore, India

S Prashanth, S3V Vascular technologies Pvt.Ltd

S3V Vascular technologies Pvt.Ltd,
Bangalore, India

References

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Published
2018-02-01
How to Cite
[1]
lakshmi, U., Sowjanya, K., Revathi, K., Shailaja, P., Ratna, J., Daniel, B.A. and Prashanth, S. 2018. A Review on European Union New Medical Device Regulations-2017. PharmaTutor. 6, 2 (Feb. 2018), 9-14. DOI:https://doi.org/10.29161/PT.v6.i2.2018.9.
Section
Articles