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!
 
Last edited by a moderator:
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#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

Involved In Discussions
#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
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).
 
Thread starter Similar threads Forum Replies Date
R FDA Requirements for a Design Technical File US Food and Drug Administration (FDA) 11
J What are the differences between a design dossier and a regular technical file? EU Medical Device Regulations 1
K Technical file for mhra CE Marking (Conformité Européene) / CB Scheme 2
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
G Same intended use devices - Technical file EU Medical Device Regulations 5
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
T Technical File Review - Transfer to a new NB EU Medical Device Regulations 3
J One Medical Device, two indications, two classes, one technical file? EU Medical Device Regulations 4
A Technical file requirement for Class IIb medical device CE Marking (Conformité Européene) / CB Scheme 3
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9
T Technical File - Previous Device Generations EU Medical Device Regulations 2
K Questions on Technical File to show it is current EU Medical Device Regulations 5
Sam Lazzara Expedited, fast-track Notified Body Technical File reviews EU Medical Device Regulations 3
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3
A Technical File Procedure (for Company) - Example wanted EU Medical Device Regulations 1
C Technical File Assessment from a NB - Clinical Equivalence CE Marking (Conformité Européene) / CB Scheme 6
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
R Technical File Guidance for Preclinical Evaluations EU Medical Device Regulations 12
S On site Technical File Review by our NB EU Medical Device Regulations 3
R ISO13485:2016 Clause 4.2.3 - Changes in Technical File Requirements ISO 13485:2016 - Medical Device Quality Management Systems 18
shimonv Which class I accessory information should be kept in the Technical File EU Medical Device Regulations 6
A Technical File Maintenance - Old generation product EU Medical Device Regulations 4
JoCam Review of Technical File for CE mark EU Medical Device Regulations 6
F Technical File - RoHS2 Technical Documentation RoHS, REACH, ELV, IMDS and Restricted Substances 2
Q Use of standard references in documentation (PRS, Technical File) Document Control Systems, Procedures, Forms and Templates 1
N CE Marking Checklist Technical File Under MRA EU Medical Device Regulations 5
A CE Mark - Maintaining Technical File and Regulatory Assessment CE Marking (Conformité Européene) / CB Scheme 1
O CE TCF (Technical Construction File) Template for LVD/EMC/Pressure Directive CE Marking (Conformité Européene) / CB Scheme 5
M Technical File Locations - Class I and Class IIa Medical Devices EU Medical Device Regulations 3
A Technical Files/Dossier/STED File Maintenance for Notified Body Audiits Other Medical Device Regulations World-Wide 2
D TENS Device (Transcutaneous Electrical Nerve Stimulator) Technical File CE Marking (Conformité Européene) / CB Scheme 4
B Which Department does the Technical File reside? EU Medical Device Regulations 9

Similar threads

Top Bottom