Regulatory Open Forum

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

In the scenario of MDR art. 120 3e: the NB#2 takes over the MDD device surveillance (until year 2027/2028) of related MDD devices (part of associated MDR contract) shall the manufacturer assign the NB#2 number on related device labels and get also (MDD?) certificate from NB#2? This is even more important if the NB#1 is not anymore MDR-designated/ listed! What are your thoughts and experience about this particular situation?

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

Hi Anon,

it might be better to open a new thread instead of reviving this one in the middle of things.

That said: The respective Q&A document by the EU states that both solutions can work (although as with all guidance documents it remains one possible interpretation and is not necessarily binding). I currently know no respective case.

Best regards, Christoph

In the scenario of MDR art. 120 3e: the NB#2 takes over the MDD device surveillance (until year 2027/2028) of related MDD devices (part of associated MDR contract) shall the manufacturer assign the NB#2 number on related device labels and get also (MDD?) certificate from NB#2? This is even more important if the NB#1 is not anymore MDR-designated/ listed! What are your thoughts and experience about this particular situation?

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

Aligned wih Christoph. 

1. Labelling could stay with the NB nb 1. Here is the extract of the Q&A, question 16  

16. In case there is an arrangement for the transfer of the surveillance to a different notified body designated under MDR, what are the implication on the labelling concerning the notified body's identification number?

Even when the appropriate surveillance is transferred to a different notified body designated under the MDR, legacy devices can continue to be placed on the market and made available without changes to the labelling, including CE marking, and thus indicate the number of the notified body that issued the certificate under the Directive and that is kept valid.

However, if practically feasible and depending on details included in the tripartite agreement (see question no 13 of this document) the manufacturer may decide to modify the labelling of legacy devices indicating the number of the notified body to which a formal application under the MDR has been lodged. 

2. To the best of my knowledge, the current MDD certificate would still valid +

                    A. tripartite contract manufacturer -NB1 - NB2 transferring the surveillance activities to NB1

                   B. confirmation letter from the NB2 on the MDR products roadmap

                   C. the self declaration - make it clear in both documents that you are switching NB.

This is also supported by the MDCG guidance 2020-3 indicating the during the transitional period, notified bodies cannot issue new MDD certificate. 

Beatrice NAJEM

CEO & founder 

QuaRex Consulting LLC 

Hi Anon,

it might be better to open a new thread instead of reviving this one in the middle of things.

That said: The respective Q&A document by the EU states that both solutions can work (although as with all guidance documents it remains one possible interpretation and is not necessarily binding). I currently know no respective case.

Best regards, Christoph

In the scenario of MDR art. 120 3e: the NB#2 takes over the MDD device surveillance (until year 2027/2028) of related MDD devices (part of associated MDR contract) shall the manufacturer assign the NB#2 number on related device labels and get also (MDD?) certificate from NB#2? This is even more important if the NB#1 is not anymore MDR-designated/ listed! What are your thoughts and experience about this particular situation?

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

Good information Beatrice.  Are you saying that the NB number can remain on the label even if the MDD NB no longer exists or is otherwise no longer available to be responsible for the MDD certificate? Thanks for your insights.

Aligned wih Christoph. 

1. Labelling could stay with the NB nb 1. Here is the extract of the Q&A, question 16  

16. In case there is an arrangement for the transfer of the surveillance to a different notified body designated under MDR, what are the implication on the labelling concerning the notified body's identification number?

Even when the appropriate surveillance is transferred to a different notified body designated under the MDR, legacy devices can continue to be placed on the market and made available without changes to the labelling, including CE marking, and thus indicate the number of the notified body that issued the certificate under the Directive and that is kept valid.

However, if practically feasible and depending on details included in the tripartite agreement (see question no 13 of this document) the manufacturer may decide to modify the labelling of legacy devices indicating the number of the notified body to which a formal application under the MDR has been lodged. 

2. To the best of my knowledge, the current MDD certificate would still valid +

                    A. tripartite contract manufacturer -NB1 - NB2 transferring the surveillance activities to NB1

                   B. confirmation letter from the NB2 on the MDR products roadmap

                   C. the self declaration - make it clear in both documents that you are switching NB.

This is also supported by the MDCG guidance 2020-3 indicating the during the transitional period, notified bodies cannot issue new MDD certificate. 

Beatrice NAJEM

CEO & founder 

QuaRex Consulting LLC 

Hi Anon,

it might be better to open a new thread instead of reviving this one in the middle of things.

That said: The respective Q&A document by the EU states that both solutions can work (although as with all guidance documents it remains one possible interpretation and is not necessarily binding). I currently know no respective case.

Best regards, Christoph

In the scenario of MDR art. 120 3e: the NB#2 takes over the MDD device surveillance (until year 2027/2028) of related MDD devices (part of associated MDR contract) shall the manufacturer assign the NB#2 number on related device labels and get also (MDD?) certificate from NB#2? This is even more important if the NB#1 is not anymore MDR-designated/ listed! What are your thoughts and experience about this particular situation?

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

In the scenario of MDR art. 120 3e: the NB#2 takes over the MDD device surveillance (until year 2027/2028) of related MDD devices (part of associated MDR contract) shall the manufacturer assign the NB#2 number on related device labels and get also (MDD?) certificate from NB#2? This is even more important if the NB#1 is not anymore MDR-designated/ listed! What are your thoughts and experience about this particular situation?

Original Message:
Sent: 28-Nov-2023 04:05
From: Erik Vollebregt
Subject: Switching Notified Bodies - Does MDD Certificate Stay Valid?

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

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

Original Message:
Sent: 22-Nov-2023 13:54
From: Anonymous Member
Subject: Switching Notified Bodies - Does MDD Certificate Stay Valid?

This message was posted by a user wishing to remain anonymous

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.

Hi Everyone,

As always, I appreciate everyone's knowledge and contribution to the forum.

My question is as follows:

We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

Thank you for your time.