CE Technical File for 1 product with different length and different trade names

#1
We are medical devices company. We have an electrode product that is using the same material and composition. The only different is the length of the electrodes. As an example we have electrodes of 18cm, 24cm, 40cm and we have already CE mark for those products. I want to know how I can update my technical file in order to ask my NB to add others electrodes as an example (15cm, 32cm, 39cm, 45cm) and how I can get CE mark for this others electrodes. Please I need your help.
 
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Stijloor

Staff member
Super Moderator
#2
We are medical devices company. We have an electrode product that is using the same material and composition. The only different is the length of the electrodes. As an example we have electrodes of 18cm, 24cm, 40cm and we have already CE mark for those products. I want to know how I can update my technical file in order to ask my NB to add others electrodes as an example (15cm, 32cm, 39cm, 45cm) and how I can get CE mark for this others electrodes. Please I need your help.
Any experts that can help?

Thank you!

Stijloor.
 
J

Jerome

#3
This is a good one to discuss with your NB.
First off, update your tech file section with product (catagory) infomration.
My NB supplied me with a guidance doc on how he'd like to see the tech.file (TF) build up. Below is a copied section:

The device structure can be defined as follows:

CE certificate, with a scope on technology level and clinical area
1) Product category (range of products or product families based on same technology and used in same clinical area); on this level the CE certificate typically is defined.
2) Product family (group of products using same technology, having same regulatory classification and for use in same clinical indications); on this level the technical documentation and declaration of conformity is put together.
3) Product type (different types within a product family, e.g. types offered in different dimensions, or types with different levels of functionality).
4) Product (individual products identified by article or catalogue number). Individual catalogue numbers are identified on the (product list attached to the) declaration of conformity.

Example:
CE01 Single use needle systems for transient and short term surgical access
Category: Needles for neurological use
Family: Electrode needles, class IIa
Family: Spinal needles, class IIa
Type: Spinal needle
Type: Spinal needle with stopcock
Family: Epidural catheters, class III
Category: Needles for soft tissue organ and abdominal access

You can add a section in your TF where you describe the variations of the original product or concept.
Also describe how you ensure these variations technically and functionally the same as the original certified product(s).
Finally an entry in the risk management file where you 'investigate(d)" the risks which could (or not) have arraised from these 'new' models.
This should suffice as its all in the same 'family', but is up to your NB to approve so discuss it with them before putting to much work into it.
I have a good open relation with my NB and the auditor brought it up as we had several devices with similar workings all seperatelly certified. His idea was to group them and certify that product family, so it would be easier for us to add similar models in the future.

just my :2cents:
 

somashekar

Staff member
Super Moderator
#4
We are medical devices company. We have an electrode product that is using the same material and composition. The only different is the length of the electrodes. As an example we have electrodes of 18cm, 24cm, 40cm and we have already CE mark for those products. I want to know how I can update my technical file in order to ask my NB to add others electrodes as an example (15cm, 32cm, 39cm, 45cm) and how I can get CE mark for this others electrodes. Please I need your help.
Into your technical file, have a matrix that shows all products and highlights the differences while it also states all the common elements and thereby show how your essential requirements checklist remains the same. Take care to include the product label details into the technical file and revise the technical file to the next indexed issue and discuss with your NB. Keep it simple if it is indeed simple and show good linkages between existing technical file information to the new added product.
 
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