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2020-06-09

Guidance on medical devices in Covid-19 context

Guidance on medical devices in Covid-19 context
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Introduction

The European Commission has published a guidance Q&A on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context.

Summary

Questions that are being addressed are:

  • What is a medical device, active implantable medical device and an in vitro diagnostic medical device?
  • What are the legal requirements for placing such medical devices on the EU market and how should the compliance with them be verified and documented?
  • How can standards be used under the legislation?
  • Where can standards be obtained?
  • Due to the urgency caused by the COVID-19 outbreak, is there a possibility to derogate from the normal conformity assessment procedures? 
  • Is it necessary to register the devices?
  • How can I get in touch with the national competent authorities?
  • Off label use of a medical device
  • Will the new Regulations on medical devices and in vitro diagnostic medical devices replace the three current Directives?

The document can be downloaded through this link.

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