Template Pack Tech File + ER + DoC


If you need to place an In-Vitro Diagnostic Medical Device in the EU Market under the legislation IVDD 98/79/EC, then this pack is for you. The IVDD will be valid until May 26th, 2022. After that, there is a transition period for some other products until May 26th 2024. We have prepared a pack that will help you to build your dossier. This is a valid template for self-certification or for a Notified Body certification.

This pack is containing:

  • Technical File Template compatible with IVDD 98/79/EC with Essential Requirement table inside (WORD File)
  • Declaration of conformity template for IVDD 98/79/EC (WORD File)

No refund will be provided.

SKU: EMD-012 + EMD-013 Category:


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