EU labeling requirement Notified body audit finding

J

Jennifer27

#1
Hi Experts!

We recently had a TUV audit at our organization and they found that we are not very well associating our devices with their corresponding IFUs.

Another problem is the name of our device on DOC does not match with what is on IFU AND we have 20 part numbers for different devices on DOC but only 10 of them are covered in IFUs.

What we intepret as a problem here because of the weak association or lack of traceability (for many part numbers) the customer might receive no IFU with a product, which could be a potential hazard AND other problem is how does TUV know if all the devices that we are marketing are covered under the DOC (since the names and part numbers do not match)

So what would be a proposed solution for this which does not require too many revisions. Can we solve this by having consistent names of devices on our IFUs and DOC?

i refer the follwing website for all guidance documents for EU regulations.
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

Could you please suggest another website where I could find all guidance documents of EU requirements and if you could let me know any specific guidance for labeling (IFU) for medical devices that would be awesome!

Thank you so much,
I look forward to your valuable feedback
Jen
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hi Experts!

We recently had a TUV audit at our organization and they found that we are not very well associating our devices with their corresponding IFUs.

Another problem is the name of our device on DOC does not match with what is on IFU AND we have 20 part numbers for different devices on DOC but only 10 of them are covered in IFUs.

What we intepret as a problem here because of the weak association or lack of traceability (for many part numbers) the customer might receive no IFU with a product, which could be a potential hazard AND other problem is how does TUV know if all the devices that we are marketing are covered under the DOC (since the names and part numbers do not match)

So what would be a proposed solution for this which does not require too many revisions. Can we solve this by having consistent names of devices on our IFUs and DOC?

i refer the follwing website for all guidance documents for EU regulations.
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

Could you please suggest another website where I could find all guidance documents of EU requirements and if you could let me know any specific guidance for labeling (IFU) for medical devices that would be awesome!

Thank you so much,
I look forward to your valuable feedback
Jen
Hi Jen.
Your DOC is the first up document which is a controlled document that your NB approves. As long as you CE mark your products, all product nomenclature, product reference that appear on the label, IFU, product litrature, must be no different than what is declared in the DOC.
You are simply not taking the vital informations from your technical file into your product information and user information.
You need no research to just keep product name and product references same across your all product label, product information litrature and product promotional litrature.

Also make sure your commercial documents refer to the products the same, to avoid competent authorities checks at port of entry.
 
R

Ron Boumans

#3
Dear Jennifer27,

All medical devices (and accessories and parts etcetera) need to be covered by the technical documentation in such a way that after an incident investigators can trace back what happened. For that it is vital that all elements of the device or system can be identified. In my work I sometimes see that the department for product design takes care of the hardware and the marketing departement supplies the label, IFU etcetera. Then it is very important that they work together. Maybe there is some room for improvement?

I agree with Somashekar that it is probably not a big deal to get all the parts identified in a consistent way.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi Jennifer,

I'll start from the end -- the webpage you specified is the right one, as far as official guidance is concerned. You could also benefit from the NB-MED "recommendations" (guidance) and GHTF rich guidance documentation. Either way, I'd simply start with the text of Essential Requirement #13, annex I of the MDD, concerning labeling content.

Further, it sounds as if you have various issues concerning documentation, cross-referencing and process control in the broader sense. I'd begin with a careful review of any NCs you got from TUV, with the intention of not only correcting them but also initiating proper corrective actions to strengthen your processes and control over them.

Do your internal auditing and CAPA systems function properly? If they do, they're supposed to bring your QMS into alignment with the applicable requirements (13485 equivalent in the EC case). If they don't, perhaps better bring in someone experienced to help you sort out what isn't really working.

Cheers,
Ronen.
 
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