TCF Contents: Once you have verified CE compliance for your product, you mustprepare a Technical Construction File (TCF) that includes both product design
documentation and, proof that the product complies with the CE Directives. Each CE
Directive specifies what must be included in the Technical Construction File (TCF). Your
CE-TCF should therefore include the information required by all CE Directives that are
listed on your Declaration of Conformity (DoC).

After the CE Mark is applied, you need to build and continue to maintain your Technical
Construction File. This file should be treated as a “living document” that requires regular
maintenance to keep it, and by extension your product, compliant with the CE
requirements.

TCF Areas to Maintain: To accurately maintain your product CE and TCF compliance,
we suggest that you include the TCF review as part of your product revision system
and, we recommend that “compliance” be included as a sign-off for all product revisions.

1) Product Variations: Each product variation or revision does not require you to start
the CE process over. You simply review the changes or differences for compliance,
document how they comply, and add it to your existing TCF.

  • Product Family: If you test one product and apply the results to a product line, you should include a breakdown of the models, model features/differences, and a compliance review of the changes. If you are declaring compliance of one model based on similarity to another model, keep a written record of your engineering rationale and decisions.
  • New Models: If you create any future product variations, you should detail the variations in your TCF and include a compliance review of the changes.
  • Product Revisions: If you make future revisions to the product, you should detail the variations in your TCF.

2) Product Design Details: Your TCF should include all final product design
documentation = Schematic Diagrams, Mechanical Diagrams, Component Details,
PCB layout and trace diagrams, Spec Sheets, CE DoC’s for major components, etc.
As part of the revision process to the product design or components, review the
changes for compliance, document how they comply, and add the updated
documentation to your existing TCF.

3) Manufacturing Details: Your TCF should include all final product manufacturing
documentation, updated as revisions occur. Manufacturing documentation and
process revisions will only require a compliance review if they result in a design
change.

4) Instruction Manual: A current copy of your instruction manual and installation
instructions should be in your TCF. You should also consider maintaining a record of
all documents provided to the customer so you can clearly know what documents
where included with each product sold.

5) Compliance Reports: Any new compliance reports generated as part of the review of
product variations, product revisions, or model additions should be added to your
TCF.

CertifiGroup are experts in all CE Directives

CertifiGroup knows your CE options

CertifiGroup can do all the CE work for you

CertifiGroup can train you in the CE Directives
& we can help you Do-It-Yourself

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