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Essential information on clinical evidence, product liability, the new role of Notified Bodies, and Zimbabwe’s medical device regulations are now available in the Journal of Medical Device Regulation’s November issue

London, 12 November 2018 – The Journal of Medical Device Regulation releases today the contents of its November 2018 issue to non-subscribing readers.

The following focus articles are now publicly available through the Journal’s website – – 10 days after their official publication in the Journal:

  • How is the strengthened role of Notified Bodies under the new EU Regulations affecting companies?
  • 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 Directive: Is it good enough for emerging technology?
  • An overview of the medical device regulations in Zimbabwe


About the Journal of Medical Device Regulation

The Journal of Medical Device Regulation reaches regulatory professionals around the world and provides them with in depth articles on current regulatory matters as well as topical information on international regulatory changes. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the global news headlines and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format.


For further information

For more information on the Journal, please contact Marija Capek (tel: +44 (0)1305 770836, email: or visit

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