7 documents to be found in the GPSR technical file
If you are planning to sell products to the EU market, it is very important that you prepare these documents thoroughly and accurately. Here, let's take a detailed look at the 7 documents that should be included in your GPSR technical file.
What's a technical file?
A technical file is a collection of documents required to prove the safety and conformity of your product. This file is prepared for submission when requested by market surveillance authorities. The technical file contains a lot of information from product design to manufacturing processes and therefore must be carefully crafted.
7 The contents of the mandatory document
Here are the 7 documents that you should have in your GPSR technical file:
- Product Definition: It must contain basic information about the product. It must contain information such as the product's name, model, areas of use. - Risk Analysis (Article 9): It must be prepared for the purpose of identifying and assessing the potential risks of the product. This document must also explain how the risks will be managed. - Test Reports: It must contain the results of tests proving the safety of the product. These reports must be prepared by independent testing laboratories. - EU Declaration of Conformity, where applicable: This document is required only when product-specific EU legislation provides for it and must be signed by an authorised signatory under that legislation.
Minimum content of the risk analysis document
According to GPSR Article 9, the risk analysis document must contain the following elements:
- Risk Definition: Potential hazards that may arise in the use of the product. Risk Assessment: Assessment of identified risks in terms of likelihood and severity. Risk Management: Suggestions on how to reduce or eliminate identified risks.
EU Compliance Statement (DoC)
An EU declaration of conformity is a document stating that your product complies with relevant EU directives. This document is prepared and signed by the manufacturer or authorised representative.
10 years of storage charge
Under GPSR, you must keep the documents in your technical file for at least 10 years from the time the product is available on the EU market.
Digital vs. Physical archiving
You can archive documents in your technical file digitally or physically. Digital archiving makes documents easier to access and saves storage space. However, physical archiving may also be necessary in some cases. Which method you choose depends on the needs of your company.
Three working days of preparation for Sunday surveillance
Market surveillance authorities may require your technical file to inspect your product, in which case you have 3 working days to prepare the required documents, so it is important that your technical file is always up to date and complete.
How do we help?
Based in Germany, we support you in the preparation of the technical documentation necessary for your GPSR compliance processes and help you take all necessary steps to ensure that your products enter the EU market safely and in a consistent manner.
If you need us, you can contact us via our assessment request form.
30-Minute GPSR Assessment
Whether your brand is entering the EU market or already selling, eugpsr.de supports you with GPSR gap assessment, documentation preparation, labelling and warning reviews, traceability structure and Responsible Person services.