Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?

Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?I've posted that previously. Have you searched the forums and the post attachments?

There is a free guidance document on the content of technical files (NB-MED/2.5.1/Rec5).

You can find it at http://www.team-nb.org/

Regards,

I search for the information as Al indicated but was unsuccessful.

Thank you Mr. cforcier for the link. It's such a great resource.

I've come to appreciate this web site.

Table Of Contents

Section 1. General Description Of Device
Section 2. Variants
Section 3. Design Drawings And Diagrams Of Components, Sub-assemblies, Etc.
Section 4. Methods Of Manufacture
Section 5. Methods Of Sterilization And Validation
Section 6. Descriptions And Explanations Of Design Drawings, Diagrams, And Operation Of Product
Section 7. Essential Requirements
Section 8. Applicable Standards
Section 9. Hazards Analysis
Section 10. Results Of Design Calculations And Inspections
Section 11. Connection To Other Devices
Section 12. Incorporation Of Medicinal Substances
Section 13. Clinical Information
Section 14. Instructions For Use
Section 15. Previous Regulatory Clearances
Section 16. Product Accessories And Instruments
Section 17. Declaration Of Conformity

Look at the thread, Technical Files - Please explain differences and what information would be included (http://elsmar.com/Forums/showthread.php?t=8658)

Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?

see attachment: "Guidance Document Technical Files / Design Dossiers"

:agree1:

Thank you everyone for your postings. I now have valuable resources I can use use put together our TF.

thank you for your help. I find it usefull.

thank you. i find it usefull

I JUST completed our Technical File (TF) for a Class IIb product. As recommended, I divided it into two parts: A & B.

Because Part A needs to go to the Authorized Representative (AR) in Europe, it is all "hard copy", meaning no links to documents on our server. Since most of Part A informatiuon is "summary" type information, this worked well. The only big single item was a print-out (2 sided) of a 125 page user manual.

Part B was a bit different. Since this does NOT need to reside in the EU with the AR, it contains many links to live documents on our server. This avoided two major issues: printing out TONS of technical data, validations, etc., and (more significantly) eliminating the need to physically remove and replace pages when documents are revised. For example, documents reverenced in Part B would NOT contain the revision level, e.g. QM-12345-XXX, where XXX was the revision level reference. Then, I added the statement: "Current revisions of all documents in Part B of thei Technical File may are maaintained on the ABC Company controlled acccess server and may be accessed at: g\document\qualitysystem\technical file". In the electronic version of Part B, this is a live hyperlink. In the printed version, it is simply blue underlined text indicating the same structure.

Both Part A & B contain a table of contents in line with the NB-MED/2.5.1/Rec 5. I have attached these as references if anyone is interested.

If anyone has interest in a particular section, let me know (via email) and I'll provide a copy (redacted as needed).

:agree: Thank you!
I find your docouments interest.

I write TCF too, but more about machines under Directive 98/37/EEC.
I am using the same index format and I have no problems with (AR) and Notified Body

thank youvery much! It's useful for me.

hello all,

We are a brandnew medical company outside EU. We are in certification stage for class IIb products. Our notified body requires the TF for review and archive. Is that normal? Does the notifed body have the right to keep a copy of our TF?

Our EC rep will keep the TF inside EU for review of competent authorities and Notified Body.

I would be happy to know your opinions to decide how to act.

Tx. This is very useful tip.

Hello all, i´m moving this thread to the CE Marking Forum.