Regulatory Open Forum

Dear Community,

The documents required to demonstrate extension of MDD CE marking as per EU regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices Q&A Rev.

1. Manufacturer self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period. Such self-declaration could be based on a harmonised template. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned.
2. 'Confirmation letter' issued by the notified body stating the receipt of the manufacturer's application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonized template

We have been submitting those for health authorities for many EU countries requesting them for registration and tender purposes. However, we got the information that those documents are to be only provided for for class III products based on a notified body's non official feedback.

Can anyone advise if they heard a similar news?

Thanks 

Dear Community,

The documents required to demonstrate extension of MDD CE marking as per EU regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices Q&A Rev.

1. Manufacturer self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period. Such self-declaration could be based on a harmonised template. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned.
2. 'Confirmation letter' issued by the notified body stating the receipt of the manufacturer's application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonized template

We have been submitting those for health authorities for many EU countries requesting them for registration and tender purposes. However, we got the information that those documents are to be only provided for for class III products based on a notified body's non official feedback.

Can anyone advise if they heard a similar news?

Thanks 

Hi Anon,

I have not heard similar feedback. In addition I am not sure if secondary information on a non-official NB's feedback is helpful here (or if the information is more detailed, then please share the actual wording).

As far a I can see the current practice on what documents to request for confirming certain devices are covered by the extension seems not very harmonized. In consequence I assume you will need to consider it on a case-by-case basis (and probably receive some strange requests along the way).

Best regards

Christoph

Dear Community,

The documents required to demonstrate extension of MDD CE marking as per EU regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices Q&A Rev.

1. Manufacturer self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period. Such self-declaration could be based on a harmonised template. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned.
2. 'Confirmation letter' issued by the notified body stating the receipt of the manufacturer's application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonized template

We have been submitting those for health authorities for many EU countries requesting them for registration and tender purposes. However, we got the information that those documents are to be only provided for for class III products based on a notified body's non official feedback.

Can anyone advise if they heard a similar news?

Thanks 

Anon,

I have not heard of this either - this seems quite off and you say 'EU countries' so presuming more than one.  Indeed it would be interesting to know which countries are requiring this information because it is not consistent with the requirements.

Hi Anon,

I have not heard similar feedback. In addition I am not sure if secondary information on a non-official NB's feedback is helpful here (or if the information is more detailed, then please share the actual wording).

As far a I can see the current practice on what documents to request for confirming certain devices are covered by the extension seems not very harmonized. In consequence I assume you will need to consider it on a case-by-case basis (and probably receive some strange requests along the way).

Best regards

Christoph

Dear Community,

The documents required to demonstrate extension of MDD CE marking as per EU regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices Q&A Rev.

1. Manufacturer self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period. Such self-declaration could be based on a harmonised template. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned.
2. 'Confirmation letter' issued by the notified body stating the receipt of the manufacturer's application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonized template

We have been submitting those for health authorities for many EU countries requesting them for registration and tender purposes. However, we got the information that those documents are to be only provided for for class III products based on a notified body's non official feedback.

Can anyone advise if they heard a similar news?

Thanks 

Anon,

I have not heard of this either - this seems quite off and you say 'EU countries' so presuming more than one.  Indeed it would be interesting to know which countries are requiring this information because it is not consistent with the requirements.

Hi Anon,

I have not heard similar feedback. In addition I am not sure if secondary information on a non-official NB's feedback is helpful here (or if the information is more detailed, then please share the actual wording).

As far a I can see the current practice on what documents to request for confirming certain devices are covered by the extension seems not very harmonized. In consequence I assume you will need to consider it on a case-by-case basis (and probably receive some strange requests along the way).

Best regards

Christoph

Dear Community,

The documents required to demonstrate extension of MDD CE marking as per EU regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices Q&A Rev.

1. Manufacturer self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period. Such self-declaration could be based on a harmonised template. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned.
2. 'Confirmation letter' issued by the notified body stating the receipt of the manufacturer's application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonized template

We have been submitting those for health authorities for many EU countries requesting them for registration and tender purposes. However, we got the information that those documents are to be only provided for for class III products based on a notified body's non official feedback.

Can anyone advise if they heard a similar news?

Thanks 

Hello All,

Thank you for your feedback!

I cite Netherlands and Slovenia for example who specifically request these documents for tenders. Turkey request them for registration purposes . Outside EU countries as well. 

The feedback from the NB said that that those documents are to be only provided for Class III products.

Anon,

I have not heard of this either - this seems quite off and you say 'EU countries' so presuming more than one.  Indeed it would be interesting to know which countries are requiring this information because it is not consistent with the requirements.

Hi Anon,

I have not heard similar feedback. In addition I am not sure if secondary information on a non-official NB's feedback is helpful here (or if the information is more detailed, then please share the actual wording).

As far a I can see the current practice on what documents to request for confirming certain devices are covered by the extension seems not very harmonized. In consequence I assume you will need to consider it on a case-by-case basis (and probably receive some strange requests along the way).

Best regards

Christoph

Dear Community,

The documents required to demonstrate extension of MDD CE marking as per EU regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices Q&A Rev.

1. Manufacturer self-declaration confirming that the conditions for the extension are fulfilled, stating the end date of the transition period. Such self-declaration could be based on a harmonised template. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned.
2. 'Confirmation letter' issued by the notified body stating the receipt of the manufacturer's application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonized template

We have been submitting those for health authorities for many EU countries requesting them for registration and tender purposes. However, we got the information that those documents are to be only provided for for class III products based on a notified body's non official feedback.

Can anyone advise if they heard a similar news?

Thanks