In-Vitro Diagnostic Medical Device Directive

In-Vitro Diagnostic Medical Device Directive

Key Facts

  • Non-EU manufacturers must appoint an Authorized Representative which is established within the Union
  • General IVDs may self-certify without the intervention of a Notified Body in order to affix the CE Marking
  • The remaining three classes - Self-testing, Annex II list and Annex II List B -  will require a QMS & Technical File to be audited by a European Notified Body
  • All IVD products must undergo a pre-Market Notification before being made available, also the ones Certified by a Notified Body
  • General requirements that must be met by manufacturers (Essential Requirements) are outlined in Annex I of the IVD Directive
  • There  is no grandfathering-in for products which have already been selling on  the EU Market - manufacturers must remain up-to-date with the most  recent requirements
  • IVD products are not being "approved" prior  sale in the EU - Competent Authorities focus on in-market controls to  verify compliance

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