A  Technical File   is a comprehensive collection of information and documents detailing everything about your medical device.  

In Europe the content of the technical file is governed by the relevant Directive(s).  These guidelines are a foundation for the regulations that outline the contents of the technical file, or technical documentation.

It is essential that manufacturers to follow the jurisdiction’s requirements for the technical file because if a manufacturer cannot follow the requirements, a market may be completely closed to the manufacturer.

If you manufacture a Class I device or self-certified IVD, a less complex CE Marking Technical File may be required.

In the case of Class IIa, IIb and Class III devices (and Annex II -  List A; Annex II, - List B; or self-testing IVD), a more complex CE Technical File or Design Dossier must be prepared.

 The EU Technical File is subject to review by a Notified Body for:

medical devices of: Class I with measuring or sterile function Class IIa, IIb Class III in vitro diagnostic medical devices of: Annex II - List A Annex II - List B self-testing IVD.
Minimum content of technical file should include: Table of contents General information concerning the structure and use EC declaration of conformity Name and address of the manufacturer and any manufacturing plants Name and address of the European Representative Product description Product specifications Product validation

 THE TECHNICAL FILE SHOULD IN ANY CASE BE AVAILABLE IN AN OFFICIAL LANGUAGEOF AN EU MEMBER STATE.