The Technical Construction File (TCF) is a file describing the apparatus and providing information and explanations as to how the applicable essential requirements have been implemented.
The technical documentation must enable the conformity of the product with the essential requirements to be assessed. It must cover the design, manufacture and operation of the product.
The manufacturer or his authorized representative must keep a copy of the declaration of conformity with the technical documentation.
The manufacturer or his authorized representative established within the Community or the person responsible for placing the apparatus on the market must keep the file for a period ending at least 10 years (!!!) after the last apparatus has been manufactured at the disposal of the relevant national authorities of any Member States for inspection.
Things to be noted:
The TCF that is created during the development may be accurate and correct. However future compliance of the product also has to be demonstrated by means of the TCF. As we all know a product will see a number of changes during its life cycle. There has to be a mechanism to ensure that product changes do not cause the product to no longer comply with the relevant standards. In cases it may be necessary to (partially) re-test a product.
A manufacturer can have multiple representatives in the EU, even for one single product. It may not be desirable to provide these representatives with detailed technical data of your product. Your representative may also be representative to your competitor
A manufacturers representative in the EU may be a sales company without very much technical expertise. Maybe not a party to leave your valuable technical data with.
Manufacturers representatives quite often change over time. This is no guarantee that the TCF will remain available for a period ending at least 10 years after the last apparatus has been manufactured
So what can CE-Real do for you?
Based on technical information provided by you, we can create your TCF
We can check if your existing TCF is correct and complies with the requirements
We can check periodically if the TCF is still up to date
Manufacturers can have multiple importers in the EU or even in a single country. This may result in maintaining multiple TCF's for each country, importer or band name. In stead we can create and maintain one single file for all and in addition we can act as the location in the EU where the TCF is stored.
We can store your TCF on multiple locations, avoiding problems due to fire, burglary, etc.
Changes in your organization may make it difficult to ensure that the TCF remains available for a period ending at least 10 years after the last apparatus has been manufactured. We can make sure you fulfill this requirement by storing the file for you.