Regulatory Open Forum

Hi experts,

We, a manufacturer of a self-certified IVD device under the IVDD, have some questions regarding the discontinuation of CE-marking and market withdrawal.

Currently, we have internally completed the manufacturing and marketing procedures, but the IVD device still remains in the EU market (France, Germany, Austria). Our EU authorized representative is located in France.

Here, my question is:

1.  Do we need to go through the process of CE-marking deregistration with the authority in France?
2.  if the answer to 1 is yes, do we need to withdraw all remaining products on the EU market before the deregistration procedure? Or is it sufficient to notify end-users that the IVD device cannot be used any longer in the EU due to CE-marking deregistration?
3.  Am I correct in understanding that as long as all products remaining on the EU market are either withdrawn or end-users are notified of our intention to no longer use the IVD device, and the CE marking de-registration procedure is completed by May 25, 2022, it is not necessary to comply with the PMS/vigilance requirements under the IVDR?
4. We have been internally keeping the actual manufactured products in case of inquiries from the distributor or end-users. Do we need such products for 5 years after the end of the sale the same as Technical Documentation?

Any comment would be appreciated.

Best regards,

In a nutshell, and as a general rule as far as I know, no "deregistration" or withdrawal or recall are legislatively required for discontinuation of CE marking unless the safety profile of the product has been declared to be directly or indirectly unacceptable.

To give basis for this interpretation, I think it's important to understand that the IVDR is centered around the notion of "placing on the market".  There may be no more important definition in the IVDR.  This is because the IVDR's fundamental objective is to assure that devices comply with the IVDR before they can be "placed on the market".  Note that "placing on the market" is a unit-based concept rather than a model-based concept.  Essentially, once a unit leaves the manufacturer's or importer's warehousing/stock control and is handed over to a courier for supply into the Union, then that device unit is considered to have been placed on the market.  In other words, during a device model's market tenure, there will be many placings on the market; specifically, one placing on the market for each unit that is made available on the Union market.

The "placing on the market" concept means that once an IVDR-compliant unit is placed on the market, then, as a general rule, there is no legislative reason for that unit to thereafter be removed from the market except in the case of an unacceptable risk.

The CE mark affixed to a device unit means that that individual device unit complied with the IVDR when it was placed on the market.  Indeed, the CE mark affixed to a device unit is only an indirect indication that the model line complies.  This is because CE marking is fundamentally a condition for placing on the market, which, as noted above, is a unit-centered event rather than a model-centered event.  Accordingly, if a manufacturer chooses to discontinue or cancel the Declaration of Conformity and, where applicable for non-self-declaration products, the EC certification, then that nonetheless doesn't invalidate the CE mark affixed to the units already placed on the market except perhaps in cases where there is an unacceptable safety issue.

Yet voluntary removals are of course permitted if a manufacturer for some reason chooses to tackle such a huge undertaking.

In a nutshell, the IVDR's PMS/vigilance requirements only apply mandatorily to devices placed on the market (i.e., removed from the manufacturer's or importer's warehousing/stock control and handed over to a courier for supply into the Union) from 25 May 2022.  I can explain further about that as needed.  So, any units already placed on the market prior to 25 May 2022 don't need to comply with the IVDR's PMS/vigilance requirements; instead, the IVDD's corresponding requirements apply for those units.

I'm unaware of anything in the outgoing IVDD or incoming IVDR that requires post-market retention samples of IVDs, though such a practice may certainly be of value for investigational purposes, or to comply with particular Member State requirements.

Hi experts,

We, a manufacturer of a self-certified IVD device under the IVDD, have some questions regarding the discontinuation of CE-marking and market withdrawal.

Currently, we have internally completed the manufacturing and marketing procedures, but the IVD device still remains in the EU market (France, Germany, Austria). Our EU authorized representative is located in France.

Here, my question is:

1.  Do we need to go through the process of CE-marking deregistration with the authority in France?
2.  if the answer to 1 is yes, do we need to withdraw all remaining products on the EU market before the deregistration procedure? Or is it sufficient to notify end-users that the IVD device cannot be used any longer in the EU due to CE-marking deregistration?
3.  Am I correct in understanding that as long as all products remaining on the EU market are either withdrawn or end-users are notified of our intention to no longer use the IVD device, and the CE marking de-registration procedure is completed by May 25, 2022, it is not necessary to comply with the PMS/vigilance requirements under the IVDR?
4. We have been internally keeping the actual manufactured products in case of inquiries from the distributor or end-users. Do we need such products for 5 years after the end of the sale the same as Technical Documentation?

Any comment would be appreciated.

Best regards,