EC Technical File DoC (Declaration of Conformity) Content Requirements

A

Arnthor

Dear All,

I am new to regulatory affairs and I need some of your help. Do my firm need to include the 1st lot of device bearing CE mark on our Technical File DOC?

Can anybody provide a list of items which must be included in the DOC? Please provide a link or website so I can show it to my boss.

Best regards.
;)
 

somashekar

Leader
Admin
Re: EC Technical File DoC (Declaration of Conformity)

Hi Arnthor.
Your Technical file will have a draft DOC and on evaluation and approval to CE mark the product, you will make a DOC which shall replace the draft and maintain this DOC (Revise wrt changes in your current CE certificate and product classification)
My DOC here if you want to cleanup and use.
 

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A

Arnthor

Re: EC Technical File DoC (Declaration of Conformity)

Hi everyone,

Thank you for the advice.

Based on what I had received, so there is not need to have the first effective lot bearing CE mark?

Please advice.
 

Peter Selvey

Leader
Super Moderator
It's not really clear what your question is, but this might help:

If you are offering a medical device for sale or otherwise "placing on the market" in Europe, you must have completed the technical file, signed declaration of conformity, and have certificates issued from a Notified Body (if necessary).

If you are being audited by a Notified Body for the first time, prior to this first sale, you can have have draft documents, and also first lots with or without CE marking ready for inspection. It does not matter, as in most cases, the Notified Body is really looking at your ability of your quality system to comply and does not directly approve the device itself.
 
A

Arnthor

Dear Peter,

Thank you for the advice.

My firm Technical File was clear many years ago and now I need is to maintain it.

In my firm DOC, there are a list of our firm products with the first lot which bear the CE marking.

My question is, can I remove the lot number?
 

Pads38

Moderator
I think that this may depend upon the sort of notified body supervision your company works under.

Your notified body certificate will show under which annex of the directive your quality system and production is audited and approved. If you have "Annex 11" (Full quality assurance system) then Lot numbers would not be needed on your DoC.

However, if you work under Annex V1 (Product quality assurance) then the DoC would only apply to that production that has been checked, so lot numbers would be required.

Hope this helps

Pads
 

Peter Selvey

Leader
Super Moderator
Hi Arnthor,

This is actually a good question and worth for everyone to know.

The original MDD required the declaration of conformity to cover a "given number of products" which did not fit with high volume manufacturing.

By way of compromise, notified bodies recommended that the starting serial number or starting lot be identified.

The revised MDD (M5 revision, effective in March 2010) removed the text and replaced with:

This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.​

Thus, you can now remove the starting lot or serial number, but you need to make sure there is a way to unambiguously link the declaration to the actual device and relevant technical documents.​
 
S

Satch

Hello folks, not really new to regulatory affars, but new to CE. Been trying to find out what information is need in a Technical File for a non-medical device. We manufacture Electric Tankless Water Heaters and passed Safety and EMC Directives with no problems. But this is haunting me. If I go to 10 Google sites, I get 10 different requirements lists. Any help to narrow it down would be appreciated!

Thanks!
 
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