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



*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.


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Regulatory Requirements for Medical Equipment