Does the technical documentation format comply with the requirements?

“Form follows function” is also true for your technical documentation: The structure of your product file is not predefined. Merely the content you are to supply as the manufacturer is defined in accordance with country-specific regulations. Different guidelines, however, make it considerably easier to set up the technical documentation:
  • Annex II “Technical documentation” according to the REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices (Europe).
  • In March 2018, IMDRF published the “In Vitro Diagnostic Medical Device Market Authorization Table of Contents” for preparing the technical documentation for different regulatory requirements (worldwide).
  • NB-MED 2.5.1: recommendation of the co-ordination of notified bodies on the minimum content of the technical documentation;
  • STED - the summary technical documentation. A standardized format published by the GHTF in 2011 with the aim to create a standard that is accepted for the approval process by many countries.
  • Depending on the target country, product information must be prepared and supplied differently.
Contact us and together we will identify your ideal document structure.

Successful product certification or submission documents seamless conformity with legal regulations. Use our know-how and be on the safe side!
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Our services in detail

  • Providing consulting services regarding the structure and format of the technical documentation,
  • Technical documentation in accordance with the specifications of the European regulation of the IVDR,
  • Developing the technical documentation in STED format,
  • Preparing the application documents in accordance with target country requirements.

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