In the current issue of the JMDR...

  • NBs: How is the strengthened role of Notified Bodies under the new EU Regulations affecting companies?
     
  • 510(k)s: Deciding when to submit a 510(k) for a change to an existing device
     
  • Clinical evidence: Current challenges for manufacturers implementing Regulation (EU) 2017/745
     
  • Product liability: Is Europe's Product Liability Directive good enough for emerging technology?
     
  • Zimbabwe: An overview of the medical device regulations in Zimbabwe, reviewed and approved by the Medicines Control Authority
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory news updates in Asia (AHWP), Australia, Brazil, Canada, Chile, China, Egypt, European Union, France, Hong Kong, India, Israel, Korea (Republic of), Malaysia, Peru, Saudi Arabia, Serbia, Singapore, Uganda, the UK, and the USA
     


 

In the previous 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