The medical device that our company manufactures will now be a Class III for CE marking purposes and we will need to create Design Dossiers for these products -- we currently have Technical Files for them as they were Class II devices.

Would someone explain the difference between a Technical File and a Design Dossier? Does anyone have a nice template or table of contents that I could use as guidance?

Thanks for your help!

A design dossier is an expanded technical file which have to be pre-submitted to the notified body, instead of being only submitted upon request. For example, if your technical file do not have your design history, you have to put it there too.

An example can be seen on this link:

http://www.tuev-sued.de/uploads/images/1134987012631647513549/MHS2%20Non%20Active%20Medical%20Devices-Products.pdf

Actually, the technical dossier must reflect all the recordings related to your engineering/development process, as defined in your quality system.

This Dossier will then not only show that you have respected your engineering process (and if you are ISO 13485, it means you will have followed MDD 93/42).

Stephane

Refer to Design Dossiers (http://www.tuvps.co.uk/uploads/images/1196777171374793101253/TUEV_XXXX_Design-Dossiers_e.pdf) here

Each conformity assessment annex of the MDD, IVD and AIMD directives requires, the manufacturer must have technical documentation for each device. The terminology technical file/ design dossier is vary by directive and annex. The term technical file is used to describe the documentation that shows how the device complies with essential requirements. For devices that require a design examination the technical construction file (TCF) is called a design dossier.

Thanks and regards
S. Subramaniam, INDIA