Qarad E-Labeling Services are fully compliant with MEDDEV 2.14/3 rev.1

This official European guidance document describes the conditions in which manufacturers of IVD products can make instructions for use available to the user.

These include:

• instructions for use must be on a dedicated website or a dedicated area of a website
• data security requirements
• users must have the opportunity to ask a copy of the instructions for use by calling a free telephone number !
• the system must be based on risk management principles

The FDA also allows that instructions for use are made available over the internet. The conditions are similar to the European ones.
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The website allows separate availability of US and EU versions of English instructions for use.

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• The regulations do not allow the use of E-Labeling Services for IVDs for self-testing and for point-of-care testing.
  
  
• For instruments, the instructions for use must also be delivered with the product.
  
  
• Regulatory restrictions may also apply outside the EU and the US.
  
  
• For details on the restrictions in the EU and the US, see the downloadable regulatory documents on this page.