“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.
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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