Regulatory Open Forum

Dear Community,

I have a scenario on which i am seeking some additional input.

As a non-EU manufacturer of IVDs (List A and List B) we supply via an importer to the EU (still under the IVDD during the transition period)

The decision has been made to cease supply of these devices to the EU and i am seeking some advice as to how long we need to keep the EC certificate valid?

Do we need only maintain the valid certificate until all the devices have been 'placed on the market' i.e shipped to the EU importer? Assuming then that since they are already placed on the market (when the EC certificate was valid) they can continue to be 'made available' and 'put into service' until expiry date of the devices.

or

Do we need to maintain the certificate until all the devices have been put into service? i.e., sent to final users?

The latter seems difficult, as many devices may be at distributors (shipped there by our importer) for an additional year or two prior to be shipped to end users.

Appreciate opinions.

Thanks

In a nutshell, if a manufacturer chooses to discontinue or cancel the IVDR Article 110 transitional IVDD Declaration of Conformity and, where applicable for non-self-declaration products, the IVDR Article 110 transitional IVDD EC Certificate, then that nonetheless doesn't invalidate the market authorization or the CE mark of units already placed on the market. The IVDD's and IVDR's "placing on the market" provisions essentially provide that once an IVDD/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. The exceptions to this are in the case of the transitional sunsetting pursuant to IVDR Article 110(4), or in the event of an unacceptable risk.

You may also find helpful a related previous discussion here that has some germane attributes to your current question.

Dear Community,

I have a scenario on which i am seeking some additional input.

As a non-EU manufacturer of IVDs (List A and List B) we supply via an importer to the EU (still under the IVDD during the transition period)

The decision has been made to cease supply of these devices to the EU and i am seeking some advice as to how long we need to keep the EC certificate valid?

Do we need only maintain the valid certificate until all the devices have been 'placed on the market' i.e shipped to the EU importer? Assuming then that since they are already placed on the market (when the EC certificate was valid) they can continue to be 'made available' and 'put into service' until expiry date of the devices.

or

Do we need to maintain the certificate until all the devices have been put into service? i.e., sent to final users?

The latter seems difficult, as many devices may be at distributors (shipped there by our importer) for an additional year or two prior to be shipped to end users.

Appreciate opinions.

Thanks

Thanks, Kevin, for the useful insight,

As a follow up, can you please clarify that if we which to cease manufacture, let our EC certificate lapse at the time that all shipments have been made to the importer, and then close the legal manufacturer facility, is there any ongoing vigilance/feedback processes that must be maintained by the legal manufacturer? I understand that the document retention shall be performed by the current authorised representative but I am unclear as to whether the legal manufacturer shall need to continue to exist to perform any ongoing services for devices already placed on the market.

Best Regards

In a nutshell, if a manufacturer chooses to discontinue or cancel the IVDR Article 110 transitional IVDD Declaration of Conformity and, where applicable for non-self-declaration products, the IVDR Article 110 transitional IVDD EC Certificate, then that nonetheless doesn't invalidate the market authorization or the CE mark of units already placed on the market. The IVDD's and IVDR's "placing on the market" provisions essentially provide that once an IVDD/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. The exceptions to this are in the case of the transitional sunsetting pursuant to IVDR Article 110(4), or in the event of an unacceptable risk.

You may also find helpful a related previous discussion here that has some germane attributes to your current question.

Dear Community,

I have a scenario on which i am seeking some additional input.

As a non-EU manufacturer of IVDs (List A and List B) we supply via an importer to the EU (still under the IVDD during the transition period)

The decision has been made to cease supply of these devices to the EU and i am seeking some advice as to how long we need to keep the EC certificate valid?

Do we need only maintain the valid certificate until all the devices have been 'placed on the market' i.e shipped to the EU importer? Assuming then that since they are already placed on the market (when the EC certificate was valid) they can continue to be 'made available' and 'put into service' until expiry date of the devices.

or

Do we need to maintain the certificate until all the devices have been put into service? i.e., sent to final users?

The latter seems difficult, as many devices may be at distributors (shipped there by our importer) for an additional year or two prior to be shipped to end users.

Appreciate opinions.

Thanks

For that answer, I'll point you to my Forum colleague Anne LeBlanc's recent post here.  If you have remaining questions, feel free to circle back for further discussion.

Thanks, Kevin, for the useful insight,

As a follow up, can you please clarify that if we which to cease manufacture, let our EC certificate lapse at the time that all shipments have been made to the importer, and then close the legal manufacturer facility, is there any ongoing vigilance/feedback processes that must be maintained by the legal manufacturer? I understand that the document retention shall be performed by the current authorised representative but I am unclear as to whether the legal manufacturer shall need to continue to exist to perform any ongoing services for devices already placed on the market.

Best Regards

In a nutshell, if a manufacturer chooses to discontinue or cancel the IVDR Article 110 transitional IVDD Declaration of Conformity and, where applicable for non-self-declaration products, the IVDR Article 110 transitional IVDD EC Certificate, then that nonetheless doesn't invalidate the market authorization or the CE mark of units already placed on the market. The IVDD's and IVDR's "placing on the market" provisions essentially provide that once an IVDD/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. The exceptions to this are in the case of the transitional sunsetting pursuant to IVDR Article 110(4), or in the event of an unacceptable risk.

You may also find helpful a related previous discussion here that has some germane attributes to your current question.

Dear Community,

I have a scenario on which i am seeking some additional input.

As a non-EU manufacturer of IVDs (List A and List B) we supply via an importer to the EU (still under the IVDD during the transition period)

The decision has been made to cease supply of these devices to the EU and i am seeking some advice as to how long we need to keep the EC certificate valid?

Do we need only maintain the valid certificate until all the devices have been 'placed on the market' i.e shipped to the EU importer? Assuming then that since they are already placed on the market (when the EC certificate was valid) they can continue to be 'made available' and 'put into service' until expiry date of the devices.

or

Do we need to maintain the certificate until all the devices have been put into service? i.e., sent to final users?

The latter seems difficult, as many devices may be at distributors (shipped there by our importer) for an additional year or two prior to be shipped to end users.

Appreciate opinions.

Thanks

Dear Community,

I have a scenario on which i am seeking some additional input.

As a non-EU manufacturer of IVDs (List A and List B) we supply via an importer to the EU (still under the IVDD during the transition period)

The decision has been made to cease supply of these devices to the EU and i am seeking some advice as to how long we need to keep the EC certificate valid?

Do we need only maintain the valid certificate until all the devices have been 'placed on the market' i.e shipped to the EU importer? Assuming then that since they are already placed on the market (when the EC certificate was valid) they can continue to be 'made available' and 'put into service' until expiry date of the devices.

or

Do we need to maintain the certificate until all the devices have been put into service? i.e., sent to final users?

The latter seems difficult, as many devices may be at distributors (shipped there by our importer) for an additional year or two prior to be shipped to end users.

Appreciate opinions.

Thanks