As we wrote in one of previous posts, in order to CE Mark a product, manufacturer has the responsibility to:
- Carry out conformity assessment.
- Set up the technical file
- Issue the EU Declaration of Conformity
- Affix a CE Mark to their product
In this text, we will do a brief explanation of what’s the big deal with technical file.
When an enforcement officer requests a copy of technical file, many companies fail to present a file within the 10 days allowed and they are prosecuted. Then, their technical file is investigated for completeness and any omissions are investigate further. This can lead to a big (in millions) fine for company. So, to prevent prosecution, it is important to present the technical file immediately and ensure that it is complete.
Good news is, that setting up a technical file, should be just collecting already existing information into one place.
Here is a brief list of what needs to be contained in the extended technical file:
- Structured table of contents or index of the information, included in the Technical Dossier
- Description of product:
- including photos, illustrations of external features, marking, internal layout
- software and firmware versions affecting the compliance
- Copy of the EU declaration of conformity
- List of directives applied
- Standards applied in full
- Standards applied in part
- Conceptual design
- Descriptions and explanations
- Descriptions of Regulatory issues, solutions, hazards, boundaries, etc.
- Results of design calculations made, examinations carried out, and other relevant similar elements
- Test report – summary
- REACH report
- ROHS report
- Product Safety report
- EMC test report
- Safety critical components
- Manufacturing drawings and instructions
- Drawings and schematics of the product
- Layout and sketches of the product
- Layout and sketches of components and sub-assemblies
- Circuit diagrams
- Process flowcharts and production tests
- How the product was made and tested
- Archive of all superseded documents
This article is just a brief guide. Please make sure you check in details what content may be required for technical file of your product.
Feel free to contact us in case you need help.