In the current issue of the JMDR...

  • European MDR: concerns over certain proposals contained in the upcoming European Medical Device Regulation (MDR)
  • PIP: implications of the EU Court of Appeal judgment on the PIP breast implant case
  • CIS region: update on the regulatory situation for medical devices in the CIS region, including the new rules for the Eurasian Economic Union (EAEU)
  • Technical documents: current and future requirements in Europe for medical device technical documentation
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Colombia, the European Union, Finland, Hong Kong, India, International, Israel, Italy, Kenya, Korea (Republic of), Malaysia, Mexico, Philippines, Singapore, the UK, Ukraine and the USA
  • Country overview: summary of the regulatory requirements for medical devices in Ukraine
  • Book review: Metals for Biomedical Devices
  • Checklist: manufacturer actions before, during and after the transitional period for the upcoming European Medical Device Regulation