Validity of CE mark on distributed product when company ceases trading

Jamie2020

Registered
Hello,

New user here hoping to get some clarity on an unusual issue - here are the details:

Company received CE certification for class 2a device based on normal conformity assessment process under MDD. The device is placed on the market with CE mark attached but device was not a commercial success and company withdraws ISO 13485 and CE certifications and then ceases trading.

What is the CE status of distibuted devices after company ceases trading ?

The question arises because a clinician who uses several of these devices wants to perform a clinical trial but his institution is requesting a valid CE certificate to "prove" the devices are CE marked and claims they are not CE marked without the CE Certificate.

I`m not sure how this will play out but curious about the collective wisdom of the forum.

Thanks,

Jamie
 

Jamie2020

Registered
Hi Sidney,

Thanks for your reply. The link that you attached is helpful but it may be slightly different as the manufacturer wishes to continue manufacturing after the CE certification is withdrawn. The case I describe above pertains to devices already in the clinic and in everyday use. There is no doubt that this is not as straightforward an issue as it initially seems.

If product has undergone conformity assessment according to Annex II of the MDD and the manufacturer has been granted a CE certificate does the Declaration of Conformity not establish conformity and CE mark validity for the product ? The issue is really just an academic one but I find it interesting nonetheless, as in, if a product is sold/in use and it`s conformity has been established then what part of the regulation would change the status of those particular (in use) devices. I can`t find anything in the regulations that suggests the manufacturers obligation for surveillance and complaint monitoring changes the CE status of sold product either - for sure this would affect the ability to sell new product.

Jamie
 

UKCAtastrophe

Registered
Hi Jamie,
I should state this is a pragmatic approach likely to be acceptable to the authorities whose focus is patient safety and may not address all legal requirements...
The law relates to each individual product placed on the market and *not* to a product type or model. Any individual product placed legally on the market under the defunct manufacturer may continue to remain in circulation until its labelled expiry date. The Importer and EU Representative should hold a copy of the technical file and be able to act as liaison for any authority queries. if your organisation is not one of these economic operators, recommend obtaining a complete copy of the technical file in order to be able to demonstrate product was approved as safe when received. As long as the product is as per the NB Technical file they have no grounds to revoke the CE Approval, but this might not stop them from trying. Recommend asking them to validate the CE Approval for product imported up to a given date, e.g. before the manufacturer withdrew the product.
 
Top Bottom