Regulatory Open Forum

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

Hi Britta,

The Commission's MDR Extension Q&A document may be helpful here:

"2. Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?

Yes, provided the MDD/AIMDD certificates have not been withdrawn by the notified body³. A notified body may withdraw a certificate if the relevant legal requirements are no longer met by the manufacturer or where a certificate should not have been issued, taking account of the principle of proportionality. The MDR certification of the device as such is not a reason for the notified body to withdraw a MDD/AIMDD certificate.

That means that a 'legacy device' and the corresponding MDR compliant device can be placed on the market in parallel until the end of the relevant transitional period.

³ A notified body letter informing about the expiry of the certificate, or a controlled phase-out of production agreed between notified body and manufacturer due to the expiry of a certificate prior to 20 March 2023, is not considered to be a withdrawal of a certificate."

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

Hi Sydney,

Thank  you! This clarifies the situation :-)

KR

Hi Britta,

The Commission's MDR Extension Q&A document may be helpful here:

"2. Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?

Yes, provided the MDD/AIMDD certificates have not been withdrawn by the notified body³. A notified body may withdraw a certificate if the relevant legal requirements are no longer met by the manufacturer or where a certificate should not have been issued, taking account of the principle of proportionality. The MDR certification of the device as such is not a reason for the notified body to withdraw a MDD/AIMDD certificate.

That means that a 'legacy device' and the corresponding MDR compliant device can be placed on the market in parallel until the end of the relevant transitional period.

³ A notified body letter informing about the expiry of the certificate, or a controlled phase-out of production agreed between notified body and manufacturer due to the expiry of a certificate prior to 20 March 2023, is not considered to be a withdrawal of a certificate."

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

Hello Britta,

Sydney provided the excellent information specific to the point.  I just wanted to provide a comment which hopefully is already being considered or in place, there should be a Quality Plan describing the transition, what activities are going on, when switch-over happens, inventory management, and finally when the Declaration of Conformity (DofC) is cancelled.  During subsequent surveillance audits, we have seen questions around this posed to companies to ensure the transition from the EU MDD to EU MDR has been properly documented and implemented.

Hi Sydney,

Thank  you! This clarifies the situation :-)

KR

Hi Britta,

The Commission's MDR Extension Q&A document may be helpful here:

"2. Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?

Yes, provided the MDD/AIMDD certificates have not been withdrawn by the notified body³. A notified body may withdraw a certificate if the relevant legal requirements are no longer met by the manufacturer or where a certificate should not have been issued, taking account of the principle of proportionality. The MDR certification of the device as such is not a reason for the notified body to withdraw a MDD/AIMDD certificate.

That means that a 'legacy device' and the corresponding MDR compliant device can be placed on the market in parallel until the end of the relevant transitional period.

³ A notified body letter informing about the expiry of the certificate, or a controlled phase-out of production agreed between notified body and manufacturer due to the expiry of a certificate prior to 20 March 2023, is not considered to be a withdrawal of a certificate."

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

One more thing to add to the technical answers above. It also depends where the AIMDD devices 'in stock' are. If they are in stock in the Union for example, they may well already count as placed on the market and could be sold off in any scenario. I always start by first looking at the status of the stock (has it been placed on the market already) before answering technical questions about whether it can be placed on the market, because that can make things a lot easier.

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

Hi Erik,

this a very good point and we are thinking very had about it. Since I am quite new to working with a non-EU based company, might I ask you an additional question here? I looked into the MDR but did not find was I was looking for. The importer is a daughter company of the non-EU manufacturer. I am not sure when devices count as brought to market in this situation. Are they brought to market when they enter EU at the importer or when the importer sells them to EU customers?

Thank you!

One more thing to add to the technical answers above. It also depends where the AIMDD devices 'in stock' are. If they are in stock in the Union for example, they may well already count as placed on the market and could be sold off in any scenario. I always start by first looking at the status of the stock (has it been placed on the market already) before answering technical questions about whether it can be placed on the market, because that can make things a lot easier.

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

Hi Erik,

this a very good point and we are thinking very had about it. Since I am quite new to working with a non-EU based company, might I ask you an additional question here? I looked into the MDR but did not find was I was looking for. The importer is a daughter company of the non-EU manufacturer. I am not sure when devices count as brought to market in this situation. Are they brought to market when they enter EU at the importer or when the importer sells them to EU customers?

Thank you!

------------------------------
Britta Cyron
Senior Specialist Regulatory Affairs

Original Message:
Sent: 19-Jan-2024 03:03
From: Erik Vollebregt
Subject: Switch from AIMDD Production to MDR Production

One more thing to add to the technical answers above. It also depends where the AIMDD devices 'in stock' are. If they are in stock in the Union for example, they may well already count as placed on the market and could be sold off in any scenario. I always start by first looking at the status of the stock (has it been placed on the market already) before answering technical questions about whether it can be placed on the market, because that can make things a lot easier.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 17-Jan-2024 07:41
From: Britta Cyron
Subject: Switch from AIMDD Production to MDR Production

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

------------------------------
Britta Cyron

------------------------------

Hi Britta,

As Anne indicated, the Blue Guide provides an explaination regarding placing on the market. Placing on the market is generally: a finished good, for which the rights have been transfered to the Union importer. The EU Commission used to have a good reference to discuss what is and is not 'placing on the market' as it related to Brexit, but that appears to have been archived. But that document also indicated: products do not yet have to be shipped to Europe. However, the goods must compliant with the legislation, the manufacturing must be complete, and the transfer of ownership must be made (e.g., bill of sale) between the two parties, with the date of transfer being the date the goods are considered placed on the market. 

The applicable Blue Guide text is:

**

A product is placed on the market when it is made available for the first time on the Union market. This operation should be done by the manufacturer or by an importer.

When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labelled in legal terms as 'placing on the market'. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.

Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question; it requires that the manufacturing stage has been completed.

This transfer could be for payment or free of charge. It does not require the physical handover of the product.

Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question; it requires that the manufacturing stage has been completed. This transfer could be for payment or free of charge. It does not require the physical handover of the product.

Sometimes products are manufactured following the placing of an order. An offer or agreement concluded before the stage of manufacture has been finalised cannot be considered as placing on the market (e.g. an offer to manufacture a product according to certain specifications agreed by the parties to the contract, where the product will only be manufactured and delivered at a later stage).

Placing on the market is considered not to take place where a product is:

• manufactured for one's own use unless Union harmonisation legislation covers products manufactured for own use in its scope (48) (49);
• bought by a consumer in a third country while physically present in that country (50) and brought by the consumer into the EU for the personal use of that person;
• transferred from the manufacturer in a third country to an authorised representative in the Union whom the manufacturer has engaged to ensure that the product complies with the Union harmonisation legislation (51);
• introduced from a third country in the EU customs territory in transit, placed in free zones, warehouses, temporary storage or other special customs procedures (temporary admission or inward processing) (52);
• manufactured in a Member State with a view to exporting it to a third country (this includes components supplied to a manufacturer for incorporation into a final product to be exported into a third country);
• transferred for testing or validating pre-production units considered still in the stage of manufacture;
• displayed or operated under controlled conditions (53) at trade fairs, exhibitions or demonstrations (54); or
• in the stocks of the manufacturer (or the authorised representative established in the Union) or the importer, where the product is not yet made available, that is, when it is not being supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonisation legislation.

------------------------------
Sydney O'Connell
Director of Global Representation
www.casusconsulting.com

Original Message:
Sent: 19-Jan-2024 03:37
From: Britta Cyron
Subject: Switch from AIMDD Production to MDR Production

Hi Erik,

this a very good point and we are thinking very had about it. Since I am quite new to working with a non-EU based company, might I ask you an additional question here? I looked into the MDR but did not find was I was looking for. The importer is a daughter company of the non-EU manufacturer. I am not sure when devices count as brought to market in this situation. Are they brought to market when they enter EU at the importer or when the importer sells them to EU customers?

Thank you!

------------------------------
Britta Cyron
Senior Specialist Regulatory Affairs

Original Message:
Sent: 19-Jan-2024 03:03
From: Erik Vollebregt
Subject: Switch from AIMDD Production to MDR Production

One more thing to add to the technical answers above. It also depends where the AIMDD devices 'in stock' are. If they are in stock in the Union for example, they may well already count as placed on the market and could be sold off in any scenario. I always start by first looking at the status of the stock (has it been placed on the market already) before answering technical questions about whether it can be placed on the market, because that can make things a lot easier.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 17-Jan-2024 07:41
From: Britta Cyron
Subject: Switch from AIMDD Production to MDR Production

Dear all,

I've got an interesting issue regarding transition from AIMDD to MDR. We are awaiting the EU-Certificate for certain products almost any day now. We have a declaration for the prolonged transition period for these products from our notified body for the AIMDD Certificate.

We will start the switch in production from AIMDD to MDR as soon as the certificates arrive. But it will take up to two month to fully transition the production and we still have products acc. to AIMDD in stock. 

We are now wondering whether the AIMDD products are still covered by the declaration reg. the transition period and we are able to sell off our stock.

Do you clever people have any insights you would like to share?

Thank you so much!

Best,

Britta

------------------------------
Britta Cyron

------------------------------