Pharmaceutical Regulatory Affairs: Open Access

Department of Pharmaceutical Regulatory affairs, Shri Vishnu College of Pharmacy (Autonomous), Vishnupur, Bhimavaram-534202, Andhra Pradesh, India

Publications

• Review   
  New Era in Medical Device Regulations in the European Union
  Author(s): Raga Padmasri Deepika Majety, Sujatha Katru, Jaya Prakash Veluchuri* and Ravi Kumar Reddy Juturi
  
  In Europe there are very high expectations regarding the quality, safety, and efficacy of medical devices. But in reality, it fails, due to many scandals that threatened the lives of thousands of people. So, the EU has introduced the new regulations in medical devices to meet the expectations. The old directives such as medical device directive (MDD) and active implantable medical device directive (AIMDD) are now replaced with medical device regulation (MDR), and in vitro diagnostic medical device directive (IVDD) is replaced with in vitro diagnostic regulation (IVDR). When compared to MDR there are more significant changes introduced in the IVDR. The New Regulations has a hard deadline for certifications and manufacturers cannot launch their product without certification, hence manufacturers have to meet the new regulations within the given time .. Read More»
  DOI: 10.37421/2167-7689.2021.10.234

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