Medical device technical file
The technical product documentation, or Medical Device Technical File , must be prepared by the manufacturer in a clear, organized, easy-to-search and unambiguous manner, including, at least:
- Product description and specifications, including variants and accessories.
- Information to be provided by the manufacturer (label and instructions for use).
- Design and manufacturing information.
- General safety and operational requirements.
- Risk management.
- Product verification and validation.
The basis and content of the Technical File is regulated by the harmonised legislation and regulations that apply to it, including all the information relating to the product, from its earliest design phases to the post-marketing monitoring required by legislation. As an essential element of the technical file, the list of general safety and operational requirements is documented.
It is the responsibility of the Technical Manager to maintain and preserve this information, making it available to the competent Authorities when required.
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