Technical File Before CE Marking
– Did You Remember It Before CE Marking & Shipping Your Products?
An important step in the process to CE Mark your product(s) is to have a properly completed technical file or design dossier, among other issues, before you place the CE Mark on your product and ship it into Europe. To CE Mark a product to any of the following product related EU Directives all require a Technical File or Design Dossier. The EU Directive list does not include amendment information. The determination if a technical file or design dossier is applicable is dependent on the classification of the product per the Directive. For the rest of the article the reference to Technical File will cover both types of documents:
Full Name of Directive
Directive Issue Number
Active Implantable Medical Device Directive
Medical Device Directive
In Vitro Diagnostic Directive
Low Voltage Directive
The technical file is used to prove conformity to the essential requirements of the directive or directives that apply to the product in question. It also needs to define the product and the product’s manufacture.
The technical file can be an index or a reference list as it would be hard to maintain all the documentation for a technical file in location of a company without extra paper handling (duplicate copies, etc.). The file can be set-up in groups or families based on product similarities. The layout of the technical file is at the manufacturer’s discretion. An important issue is to be able to proceduralize the technical file so when updates to products occur the technical file is updated to reflect these changes and the history of the product/file is maintained. The technical file’s access should be a controlled and kept up-to-date as discussed above. If your product also requires a Quality System as part of the CE Marking process then the technical file needs to be available during the audits conducted by the Notified Body that audits your company. The time period for how long the documents must be maintained after the last product is made varies between the Directives.
Like other important documentation that is required to be able to CE Mark a product the manufacture has the responsibility to be able to get the technical file to the Competent Authority in Europe if they require this information. Typically a Competent Authority may request the technical file if an incident has been reported that the product failed, compromised safety or the health of the user, patient, etc.
If you have questions about technical files, CE Mark, or product safety issues please contact Leo at EisnerSafety dot com