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

J

jdy11

#1
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!
 
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Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
S

smorvan

#3
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

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
 

bio_subbu

Super Moderator
#5
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

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
 
O

oleon

#6
Re: Technical File vs Design Dossier?

Hi Marcelo,

Very much interested to see the example, but your link does not work.
Can you fix it, please?
Thanks,
Olga
 

Castaway99

Starting to get Involved
#8
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

Hello Ronen,
Went through the TUV Seud document. Doesn't the Design Dossier also require documents and records pertaining to design and development process, Design and development plans, reviews etc...............
 
W

Watchwait

#9
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

PLs clarify: Per 93/42/eec, Design Dossier (Class III documentation) requires preassessment & approval by NB PRIOR to marketing in the EU. Technical File (Class II documentation) requires only that documentation be prepared prior to distribution & made availabe to NB for their review (and thus not necessarily postponing distribution in the EU pending NB review). The device in question is an active, non-implantable medical device.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
Re: Technical File vs. Design Dossier? Class II and Class III Medical Devices

Not sure what is the source, in reality there is no such difference (except of course devices in class I).
 

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