Medical Device File Template - In Vitro Diagnostics (EU 2017/746)

Medical Device File Template - In Vitro Diagnostics (EU 2017/746)

This medical device file template is set out to meet the requirements set out in Annex II of In Vitro Diagnostic Device Regulation EU 2017/746 for documentation required to demonstrate conformity to the regulations.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.