Technical File vs. Design Dossier - Class II and Class III Medical Devices

pkost

Trusted Information Resource
#11
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

I'm not keen on the terminology, but there are two parts:
Technical file: summary documentation (see STED)
Design dossier: detailed and comprehensive documentation of the design process and steps.

Class III
Technical file and Design dossier must be reviewed by NB before marketing

Class IIa/b
Technical file must be reviewed by NB before marketing
Design dossier may be reviewed as part of a review of your quality system

Class I (excluding measuring and sterile)
No NB review required before marketing
technical file/design dossier may be reviewed as part of a QMS review
 
Elsmar Forum Sponsor
J

Julie O

#12
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

Just wanted to point out that there is no reference to a "technical file" in the MDD and the corresponding MEDDEV doesn't describe the contents of a "technical file," either, but instead addresses "technical documentation."

The MDD uses the term "design dossier" only once:

4.1. In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in Section 3.1.
4.2. The application must describe the design, manufacture and performances of the product in question. It must include the documents needed to assess whether the product conforms to the requirements of this Directive, as referred to in Section 3.2 (c).

I find 4.2 confusing. I think some people take it to mean that the design dossier must describe the design, manufacture, and performances of the product, while others take it to mean that the application must describe the design (by including a design dossier) as well as manufacture, and performances of the product.

I agree with pkost's perspective on this. I see a lot of manufacturers including information regarding manufacture and performances of the product in their design dossier, which the NB is then only too happy to review and question, but which I think should not be there. However, having seen a lot of this information in design dossiers, now some NBs want to see all this information included, where I'm doubtful that this was the original intent. I think the design dossier was probably intended to include the information that resulted from the application of design controls.
 
J

Julie O

#13
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

pkost, do you have an outline of the contents of a design dossier that you could share? Either your own or one officially sanctioned by a NB?
 
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