Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy (Autonomous), Vishnupur, Bhimavaram, Andhra Pradesh, India, 534202
*Corresponding author Tel.: +91-9949204201, E-mail address: sujathakatru1996@gmail.com (Sujatha Katru)
Online published on 24 May, 2021.
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).
MDR, Implants, Medical devices, CE mark, EU, FDA, MDD, 510(k) pathway
