In the current issue of the JMDR...

  • MEDDEV 2.7/1: A critical examination of the fourth revision of MEDDEV 2.7/1, the European guideline on clinical evaluations
     
  • DEHP: The regulation of DEHP in medical devices: continued use or restrictions?
     
  • Adaptive design: Reducing uncertainty in medical device development: How the US FDA's guidance on adaptive design for clinical studies can help
     
  • Reprocessing: How will the new EU Medical Devices Regulation affect the reprocessing of single-use devices
     
  • Taiwan: an overview of the laws and regulations for medical devices in Taiwan
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Colombia, Ecuador, the European Union, Finland, France, India, Ireland, Japan, Korea, Malaysia, Saudi Arabia, South Africa, Switzerland, Taiwan, the UK, the USA and Vietnam
     

In the previous issue of the JMDR...

  • Japan: Impact of recent changes to Japan's medical device regulations: a Competent Authority perspective
     
  • Biological evaluation: US FDA guidance on the use of ISO 10993-1 for the biological evaluation of medical devices: the top 10 changes affecting medical device manufacturers
     
  • Dominican Republic: Addressing the challenges of medical device registration in the Dominican Republic - requirements, trademarks, samples and timeframes: a Competent Authority perspective
     
  • LDTs: The need for increased US FDA oversight of laboratory-developed and other laboratory tests
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Argentina, Australia, Brazil, Canada, China, Colombia, the European Union, France, Korea, Malaysia, Myanmar, Russia, Saudi Arabia, South Africa, Sweden, Switzerland, Taiwan, Thailand, the UK and the USA
     
  • Country overview: summary of the regulatory requirements for medical devices in the Republic of Panama (written by the Competent Authority)