Regulatory Open Forum

Hi

We are a distributor who wants to become the Legal Manufacturer for the products that we distribute, as the manufacturing site does not want to transition to MDR. (With this change, they will keep manufacturing the products but now for us, as LM)

As distributors, we do not have a big expertise in regulatory topics and that's why we would like to ask you for some guidance about how to do this change. Apart from building a technical documentation which other steps are involved in terms of regulatory and quality

Also, how could we do to take advantage of the transition period so we can contiue marketing the products until we become the LM and we transition the products to the MDR?

Thank you very much in advance for your help

Hi

We are a distributor who wants to become the Legal Manufacturer for the products that we distribute, as the manufacturing site does not want to transition to MDR. (With this change, they will keep manufacturing the products but now for us, as LM)

As distributors, we do not have a big expertise in regulatory topics and that's why we would like to ask you for some guidance about how to do this change. Apart from building a technical documentation which other steps are involved in terms of regulatory and quality

Also, how could we do to take advantage of the transition period so we can contiue marketing the products until we become the LM and we transition the products to the MDR?

Thank you very much in advance for your help

Indeed it is possible to separate the role of legal manufacturer from that of the producer of a device. The challenge is that the legal manufacturer must take full responsibility for the device. That also means that the declaration of conformity and the certificate are linked to the legal manufacturer. If that role changes, those document become void. Only the current legal manufacturer can use the extra transitional period from Regulation 2023/607. On top of that, you must make the switch from distributor to legal manufacturer. I consider that a challenge. 

In the case of only Class I, self-certified, devices, it may be possible to get the documentation ready in a relatively short time (as well as getting the organization ready for that role). Only then, you can start placing these devices on the market under your name as the legal manufacturer.

In the case of notified body certified devices, the process becomes more complex and time consuming. Keving Randall suggests to try finding an exemption via the current notified body. I would suggest to have a Plan B and a Plan C. Without more information about your organization, I cannot develop those. 

Hi

We are a distributor who wants to become the Legal Manufacturer for the products that we distribute, as the manufacturing site does not want to transition to MDR. (With this change, they will keep manufacturing the products but now for us, as LM)

As distributors, we do not have a big expertise in regulatory topics and that's why we would like to ask you for some guidance about how to do this change. Apart from building a technical documentation which other steps are involved in terms of regulatory and quality

Also, how could we do to take advantage of the transition period so we can contiue marketing the products until we become the LM and we transition the products to the MDR?

Thank you very much in advance for your help

Also Anon, if the subject device is a class I self-declaration product, then be sure to remember that those still must meet substantive requirements such as GSPR conformity, technical documentation, quality management system, post-market surveillance, Article 10 compliance, etc., etc.  Accordingly, even if the subject device is a class I self-declaration device, then be careful not to underestimate the scope of the transfer task.

Indeed it is possible to separate the role of legal manufacturer from that of the producer of a device. The challenge is that the legal manufacturer must take full responsibility for the device. That also means that the declaration of conformity and the certificate are linked to the legal manufacturer. If that role changes, those document become void. Only the current legal manufacturer can use the extra transitional period from Regulation 2023/607. On top of that, you must make the switch from distributor to legal manufacturer. I consider that a challenge. 

In the case of only Class I, self-certified, devices, it may be possible to get the documentation ready in a relatively short time (as well as getting the organization ready for that role). Only then, you can start placing these devices on the market under your name as the legal manufacturer.

In the case of notified body certified devices, the process becomes more complex and time consuming. Keving Randall suggests to try finding an exemption via the current notified body. I would suggest to have a Plan B and a Plan C. Without more information about your organization, I cannot develop those. 

Hi

We are a distributor who wants to become the Legal Manufacturer for the products that we distribute, as the manufacturing site does not want to transition to MDR. (With this change, they will keep manufacturing the products but now for us, as LM)

As distributors, we do not have a big expertise in regulatory topics and that's why we would like to ask you for some guidance about how to do this change. Apart from building a technical documentation which other steps are involved in terms of regulatory and quality

Also, how could we do to take advantage of the transition period so we can contiue marketing the products until we become the LM and we transition the products to the MDR?

Thank you very much in advance for your help

Thank you very much for your reply. Indeed, we consider it a bit challenge, that's why we are very concerned about the change and all the implicantions. We are aware of Article 10 fo the MDR but not sure how to address all the points, especially the ones about PMS, RM.. We know that for certain topics we will nedd to hire someone to help us such as for the CER / PMCF, BER..

We understand that we have to develop all the procedures related to RM, Change controls and also to involve the current manufacturing site in our QMS

Our products are class III medical devices, which adds an extra layer of complexity

Thanks all for your replies

Also Anon, if the subject device is a class I self-declaration product, then be sure to remember that those still must meet substantive requirements such as GSPR conformity, technical documentation, quality management system, post-market surveillance, Article 10 compliance, etc., etc.  Accordingly, even if the subject device is a class I self-declaration device, then be careful not to underestimate the scope of the transfer task.

Indeed it is possible to separate the role of legal manufacturer from that of the producer of a device. The challenge is that the legal manufacturer must take full responsibility for the device. That also means that the declaration of conformity and the certificate are linked to the legal manufacturer. If that role changes, those document become void. Only the current legal manufacturer can use the extra transitional period from Regulation 2023/607. On top of that, you must make the switch from distributor to legal manufacturer. I consider that a challenge. 

In the case of only Class I, self-certified, devices, it may be possible to get the documentation ready in a relatively short time (as well as getting the organization ready for that role). Only then, you can start placing these devices on the market under your name as the legal manufacturer.

In the case of notified body certified devices, the process becomes more complex and time consuming. Keving Randall suggests to try finding an exemption via the current notified body. I would suggest to have a Plan B and a Plan C. Without more information about your organization, I cannot develop those. 

Hi

We are a distributor who wants to become the Legal Manufacturer for the products that we distribute, as the manufacturing site does not want to transition to MDR. (With this change, they will keep manufacturing the products but now for us, as LM)

As distributors, we do not have a big expertise in regulatory topics and that's why we would like to ask you for some guidance about how to do this change. Apart from building a technical documentation which other steps are involved in terms of regulatory and quality

Also, how could we do to take advantage of the transition period so we can contiue marketing the products until we become the LM and we transition the products to the MDR?

Thank you very much in advance for your help

Hi

We are a distributor who wants to become the Legal Manufacturer for the products that we distribute, as the manufacturing site does not want to transition to MDR. (With this change, they will keep manufacturing the products but now for us, as LM)

As distributors, we do not have a big expertise in regulatory topics and that's why we would like to ask you for some guidance about how to do this change. Apart from building a technical documentation which other steps are involved in terms of regulatory and quality

Also, how could we do to take advantage of the transition period so we can contiue marketing the products until we become the LM and we transition the products to the MDR?

Thank you very much in advance for your help

Hi

We are a distributor who wants to become the Legal Manufacturer for the products that we distribute, as the manufacturing site does not want to transition to MDR. (With this change, they will keep manufacturing the products but now for us, as LM)

As distributors, we do not have a big expertise in regulatory topics and that's why we would like to ask you for some guidance about how to do this change. Apart from building a technical documentation which other steps are involved in terms of regulatory and quality

Also, how could we do to take advantage of the transition period so we can contiue marketing the products until we become the LM and we transition the products to the MDR?

Thank you very much in advance for your help