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Technical files - EU

Introduction

To comply with European legislation around product compliance, you need to be able to provide evidence, stored in a so-called Technical file. You can create your own Technical file within the ProductIP platform. The process of making a Technical file can be divided in a couple of steps.

Summary

Feel overwhelmed about all the steps you need to take? Follow our free online training first Three 45 minute, free, online sessions make all the difference. Not enough time, not enough knowledge? At any time within the process you can outsource some or all work to ProductIP, increasing your efficiency and making sure you are minimizing risk.

What it's about

  1. Answer questions regarding your product, the answers to the questions will define what requirements apply to your product! Once finished with answering the questions you’ve created your Technical file with a comprehensive and monitored requirement list as the basis.
  2. View the requirement list and see what kind of documents you should provide as evidence for those requirements.
  3. Upload documents or send your supplier an invite from within the platform giving them rights, assign a task, to upload documents.
  4. Review all documents and link them to the requirements. We developed a tool to help you with this step. MatchIT scans the documents and where possible provides suggestions as to what requirements you be signed of with it. Signing of requirements with evidence will allow you to see progress on the overall completion of the Technical file.
  5. Push your supplier where needed and close the Technical file whenever you think it provides enough evidence.
  6. You’ve successfully created your first Technical file! We monitor the relevancy of the requirement list in the context of changing regulation. The indicate of the file may change from green to orange to red. Red means new evidence should be collected in order to be able to support the compliance of a new shipment (re-order). Simply clone the Technical file for the re-orders and collect the required new evidence.

Additional resources:

Platform Manual - English

Platform Manual - German