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:
in vitro diagnostic medical devices of:
Minimum content of technical file should include:
THE TECHNICAL FILE SHOULD IN ANY CASE BE AVAILABLE IN AN OFFICIAL LANGUAGEOF AN EU MEMBER STATE.
Medical Device once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time.