Technical File

A Technical File is proof that a medical device complies with the essential safety and health requirements set down by  the relevant Directive(s). Technical Files are required for all classes  of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device,  including photographs and diagrams.

A Technical File can be compiled in  any of the official languages of the EU.  However, English is the most commonly used. An up to date electronic or  hard copy of the file needs to be kept available in Europe allowing it  to be presented to any EU Competent Authorities upon request.  Manufacturers based outside the EEA are to make it available at the  address of their European Authorized Representative. As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.

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