In Vitro Diagnostic Directive (IVDD) 98/79/EC

Obtain Regulatory Approvals for EU Market Access for IVDD 98/79/EC

Ensure your in vitro diagnostic medical device meets the essential requirements of the In Vitro Diagnostic Directive (IVDD), including quality system, design, manufacturing, packaging, and labeling requirements. We can help you navigate the CE Marking process, prepare your technical file, establish a monitoring system and incident reporting system, document risk, and prepare a Declaration of Conformity for your products within the scope of the Directive:

  • Self-testing devices (products deemed for home-use)
  • Reagents/reagent products (Annex II, List A Devices; Annex II, List B Devices)
  • All other medical devices to be used in-vitro for the examination of blood or tissue specimens

In Vitro Diagnostic Medical Equipment Overview



Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.


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Regulatory Requirements for Medical Equipment