Pharmaceutical Regulatory Affairs: Open Access

Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, India

Publications

• Research Article   
  A Review of the New European Medical Device Regulations
  Author(s): Natarajan Jawahar*, Nimase Akshay Ashok, Bala Sai Soujith Nidamanuri, Senthil Venkatachalam and Jubie Selvaraj
  
  Introduction: This article provides an overview of important new regulations and policies, including some new guidance’s regarding research related to medical devices in the European Union. Also, the new timelines for submission documents. The medical device classification system has been updated to better represent the potential health concerns connected with the usage of modern high-end technologies in healthcare. Also express the major changeover that the new MDR brings to the medical devices industry, focusing on clinical investigations and clinical evaluations. The aim of this work is to give an overview of the new medical device regulations as well as the functions and activities under the European medical agency in terms of assessment, appraisal, and ongoing evaluation of medical devices. This modification ensures a high degree of safety and health via th.. Read More»
  DOI: 10.37421/2167-7689.2022.11.298

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