New regulations on Medical Devices in European Union

  • Sujatha Katru SINDHUJA C
  • Raga Padmasri Deepika Majety
  • Jaya Prakash Veluchuri
  • Sita Priya Darsini Yallabandi
  • Ravi Kumar Reddy Juturi

Abstract

Due to the lack of sound approval process for medical devices in the EU people are suffered from many side effects. Some of the case studies which reflected mainly for the transformation of medical device regulations are PIP implants, MOM hip implants, COSTAR drug-eluting stent, and pleural seal, etc. To reflect the progress over the last 20 years, the EU revised the legal framework. Regulation (EU) 2017/745 on medical devices (MDR) introduces a major update of the regulatory framework in the European Union (EU). The modernization of the European regulatory system brings several changes compared to old directives which impact mainly manufacturers and SMEs. The new rules will fully be applied after the transitional period 3 years for MDR (up to 2020).

Keywords: MDR, Implants, Medical devices, CE mark, EU, FDA, MDD, 510(k) pathway

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References

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How to Cite
Katru, S., R. P. Deepika Majety, J. P. Veluchuri, S. P. Darsini Yallabandi, and R. K. Reddy Juturi. “New Regulations on Medical Devices in European Union”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 3, Sept. 2020, pp. 11-21, doi:10.22270/ijdra.v8i3.394.