Technical File for CE Mark declaration - Template or Sample of required contents

W

Watchwait

#11
Re: Technical File for CE declaration - Template or Sample of required contents

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).
 

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D

ddaniel

#12
Re: Technical File for CE declaration - Template or Sample of required contents

: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
 
Q

qincai212

#13
Re: Technical File for CE declaration - Template or Sample of required contents

thank youvery much! It's useful for me.
 
J

jdextra

#14
Re: Technical File for CE declaration - Template or Sample of required contents

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.
 
P

pgopgo

#15
Re: Technical File for CE declaration - Template or Sample of required contents

Tx. This is very useful tip.
 

Marcelo

Inactive Registered Visitor
#16
Re: Technical File for CE declaration - Template or Sample of required contents

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

akochi

#17
Re: Technical File for CE declaration - Template or Sample of required contents

I'm looking for some help to write a technical file for an aneroid sphygmomanometer (Class I with measuring function). I have a few questions about some of the language that is used in the essential requirements of MDD 93/42/EEC...

7.2 "...minimize the risk posed by contaminants and residues to the persons..."

7.3 "...used safely with materials, substances and gases with which they enter into contact..."

7.6 "...risks posed by the unintentional ingress of substances of substances..."

9.3 "...minimize the risks of fire or explosion..."

if my product that I am writing a TF for, is a simple manual blood pressure cuff, do these essential requirements apply?

Sorry for such a basic question...

:thanx:
 
#18
Re: Technical File for CE declaration - Template or Sample of required contents

7.2 Your cuff needs to be suitable for use - so sufficiently bio-compatible for skin contact. And people may attempt use on broken skin, even if the Instructions say not to.

7.3 N/A
Not designed for use with any other substances.

7.6 Fluid ingress - consider any cleaning / disinfection procedure.

9.3 N/A
Not used with any flammable substance and no power source.

Welcome to the Cove!
 

Ronen E

Problem Solver
Staff member
Moderator
#19
Re: Technical File for CE declaration - Template or Sample of required contents

7.2 Your cuff needs to be suitable for use - so sufficiently bio-compatible for skin contact. And people may attempt use on broken skin, even if the Instructions say not to.

7.3 N/A
Not designed for use with any other substances.

7.6 Fluid ingress - consider any cleaning / disinfection procedure.

9.3 N/A
Not used with any flammable substance and no power source.

Welcome to the Cove!
My take:

7.3 The cuff materials should be shown to not being significantly affected by skin secretions.

9.3 If the cuff materials have fire retardant properties, listing them can save some questions during audit.

Cheers,
Ronen.
 
A

akochi

#20
Thank you for your help!

Also looking to see if there are any technical files of aneroid sphygmomanometers anyone is willing to share!

:thanx:
 
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