In the current issue of the JMDR...

  • EU ARs: An in-depth discussion of the legal liability of European Authorised Representatives
     
  • Importers/distributors: An examination of the obligations and liabilities of importers and distributors of medical devices in Europe and the impact of Regulation 2017/745
     
  • Quality Systems: Understanding the differences between the US Quality System regulation and ISO 13485:2016 and why those differences are important
     
  • Combinations: A look at how the regulation of combination products in the EU is affected by the new Medical Devices Regulation, and whether the EU would benefit from following the US approach
     
  • Parallel Review: The FDA and CMS provide a brief background to the US Parallel Review Program, explain how it works, provide a discussion on the lessons learned and the programme’s status, and present a vision for its future
     
  • Russia: A summary of the regulatory control of medical device circulation in the Russian Federation written by Roszdravnadzor
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory news updates in Australia, Brazil, Canada, China, Egypt, the EU, France, Germany, Hong Kong, India, International, Ireland, Kenya, Korea (Republic of), Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, Spain, Switzerland, the UK, and the USA
     


 

In the previous issue of the JMDR...

  • Implantables: Guest Editorial looking at the legal ownership of implanted medical devices
     
  • Environment: An examination of medical device environmental waste management regulations, systems, standards and guidance
     
  • 3D printing: Does the text of the new Medical Devices Regulation help to clarify the legal status of 3D printing in Europe?
     
  • Pakistan: An overview of Pakistan's new 'Medical Devices Rules, 2017'
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory news updates in Australia, Bahrain, Brazil, Canada, China, the EU, Hong Kong, India, International, Ireland, Israel, Kuwait, Malaysia, Mexico, New Zealand, Oman, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, Switzerland, the UAE, Uganda, the UK, the USA, and the Yemen
     
  • Book review: 'Biomaterials in Orthopedics'