In Vitro Diagnostic Directive 98.79.EC

Obtain Regulatory Approvals for EU Market Access

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

Learn about our Notified Body status and what it means for your device.

 

 

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

 

Need help or have a question?

+1 800 967 5352
UK/EIRE:
+44 1372 370900
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+55 11 2842 0444
APAC:
+86 400 886 9926
EMEA:
+46 8 750 0000
Germany
+49 711 27311 152
UAE
+971 4 317 8777
 

Regulatory Requirements for Medical Equipment