Regulatory Open Forum

Dear all,

We are a manufacturer for class I and IIa Medical devices (among others TENS/EMS-Therapy). We manufacture and distribute our own devices. For this I needed under MDD a DIMDI-registration. Under MDR, I need a SRN from EUDAMED. To my knowledgde, I need 1 SRN as manufacturer.

We do also sell medical devices of other manufacturer, i.e. electrode gel, a class I medical device. The manufacturer asked me to sign a new distribution contract according to the requirements of the MDR. In this contract I have to state whether I need to register myself with local (German) compent authorities as distributor because this is would be differently handled in the different EU-member states.

This caught me kind of on the wrong foot, because I have studied the MDR and the German laws soley under the manufacturers point of view. I just started to depen my knowledge regarding EUDAMED-registration as well.

Can you help me answering the question whether I need to register as distributor in Germany?

Thank you!

Britta

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Dear Britta,

Distributors are not required to be registered in EUDAMED.
Article 31 of MDR 2017/745 requires the registration of manufacturers, authorised representatives and importers, but not for distributors.

If the distributor applies certain changes to the medical device, obligations of manufacturers apply to distributors, see article 16 for more details.

------------------------------
Franz Menean
MEDAGENT GmbH
Mühlheim
Germany
------------------------------

Original Message:
Sent: 26-Aug-2021 10:32
From: Britta Cyron
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear all,

We are a manufacturer for class I and IIa Medical devices (among others TENS/EMS-Therapy). We manufacture and distribute our own devices. For this I needed under MDD a DIMDI-registration. Under MDR, I need a SRN from EUDAMED. To my knowledgde, I need 1 SRN as manufacturer.

We do also sell medical devices of other manufacturer, i.e. electrode gel, a class I medical device. The manufacturer asked me to sign a new distribution contract according to the requirements of the MDR. In this contract I have to state whether I need to register myself with local (German) compent authorities as distributor because this is would be differently handled in the different EU-member states.

This caught me kind of on the wrong foot, because I have studied the MDR and the German laws soley under the manufacturers point of view. I just started to depen my knowledge regarding EUDAMED-registration as well.

Can you help me answering the question whether I need to register as distributor in Germany?

Thank you!

Britta

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Hi Britta,

there is no general registration obligation for distributors in the MDR or IVDR. However, the related german law was recently updated and has the nice german title (Medizinprodukteanpassungsgesetzt - guess this is a typical german word). Although I am not a specialist in this law there is a paragraph 88 (9) that states that the german authority is allowed to define that distributors need to be locally registered. If this has really happened, I don´t know. Unfortunately, I also don´t have an english version of the law.

Sorry to not be of more help - All the Best

Markus

------------------------------
Markus Lantermann
Head of Q&R Region International
Mannheim
Germany
------------------------------

Original Message:
Sent: 26-Aug-2021 10:32
From: Britta Cyron
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear all,

We are a manufacturer for class I and IIa Medical devices (among others TENS/EMS-Therapy). We manufacture and distribute our own devices. For this I needed under MDD a DIMDI-registration. Under MDR, I need a SRN from EUDAMED. To my knowledgde, I need 1 SRN as manufacturer.

We do also sell medical devices of other manufacturer, i.e. electrode gel, a class I medical device. The manufacturer asked me to sign a new distribution contract according to the requirements of the MDR. In this contract I have to state whether I need to register myself with local (German) compent authorities as distributor because this is would be differently handled in the different EU-member states.

This caught me kind of on the wrong foot, because I have studied the MDR and the German laws soley under the manufacturers point of view. I just started to depen my knowledge regarding EUDAMED-registration as well.

Can you help me answering the question whether I need to register as distributor in Germany?

Thank you!

Britta

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Hi Markus,

I think you mean paragraph 88 (8), as there is no 88 (9) of MPDG. (I am German native speaker ;-)). I feared something like this. do you have an ides, where might find out if, and where I need to register?

Thank you!

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Original Message:
Sent: 27-Aug-2021 01:35
From: Markus Lantermann
Subject: MDR MAnufacturer and Distributor Registration Germany

Hi Britta,

there is no general registration obligation for distributors in the MDR or IVDR. However, the related german law was recently updated and has the nice german title (Medizinprodukteanpassungsgesetzt - guess this is a typical german word). Although I am not a specialist in this law there is a paragraph 88 (9) that states that the german authority is allowed to define that distributors need to be locally registered. If this has really happened, I don´t know. Unfortunately, I also don´t have an english version of the law.

Sorry to not be of more help - All the Best

Markus

------------------------------
Markus Lantermann
Head of Q&R Region International
Mannheim
Germany

Original Message:
Sent: 26-Aug-2021 10:32
From: Britta Cyron
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear all,

We are a manufacturer for class I and IIa Medical devices (among others TENS/EMS-Therapy). We manufacture and distribute our own devices. For this I needed under MDD a DIMDI-registration. Under MDR, I need a SRN from EUDAMED. To my knowledgde, I need 1 SRN as manufacturer.

We do also sell medical devices of other manufacturer, i.e. electrode gel, a class I medical device. The manufacturer asked me to sign a new distribution contract according to the requirements of the MDR. In this contract I have to state whether I need to register myself with local (German) compent authorities as distributor because this is would be differently handled in the different EU-member states.

This caught me kind of on the wrong foot, because I have studied the MDR and the German laws soley under the manufacturers point of view. I just started to depen my knowledge regarding EUDAMED-registration as well.

Can you help me answering the question whether I need to register as distributor in Germany?

Thank you!

Britta

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Dear Britta,

 

The answer you can find black on white within the Actor registration module FAQ document at:

https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_actor_module_q-a_en.pdf

 

Here it states:

"4.5.1 Does Distributors need to register on EUDAMED?

The Distributors do not need to register and cannot register in EUDAMED. There is no actor role for distributor/wholesaler in EUDAMED and therefore no SRN for them."

 

Best Regards,

Stephanie

MedTechXperts GmbH
Jungenbergstrasse 7
CH-5023 Biberstein
Switzerland

sgrassmann@medtechxperts.com
info@medtechxperts.com
http://www.medtechxperts.com

 

Expediting Market Access & Ensuring the Success of Your Medical Device

------------------------------
Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
------------------------------

Original Message:
Sent: 26-Aug-2021 10:32
From: Britta Cyron
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear all,

We are a manufacturer for class I and IIa Medical devices (among others TENS/EMS-Therapy). We manufacture and distribute our own devices. For this I needed under MDD a DIMDI-registration. Under MDR, I need a SRN from EUDAMED. To my knowledgde, I need 1 SRN as manufacturer.

We do also sell medical devices of other manufacturer, i.e. electrode gel, a class I medical device. The manufacturer asked me to sign a new distribution contract according to the requirements of the MDR. In this contract I have to state whether I need to register myself with local (German) compent authorities as distributor because this is would be differently handled in the different EU-member states.

This caught me kind of on the wrong foot, because I have studied the MDR and the German laws soley under the manufacturers point of view. I just started to depen my knowledge regarding EUDAMED-registration as well.

Can you help me answering the question whether I need to register as distributor in Germany?

Thank you!

Britta

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Guten Tag Britta,

There was a previous post on this about distributor registration, indeed as others have said there is no Actor registration of distributors in EUDAMED.  If you look at Article 30 it states local authorities may implement registration requirements for distributors.  We understand there will be a few Member States doing this, requiring registration of distributors, to help with tracking of medical devices through the distribution chain.  I also do not know where any registration as a distributor is currently for Germany, but maybe would suggest contacting BfArM or your local office.  For me, this is going to be an important point of regulatory intelligence for manufacturers to understand which Member States require distributor registration.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 27-Aug-2021 03:10
From: Stephanie Grassmann
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear Britta,

 

The answer you can find black on white within the Actor registration module FAQ document at:

https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_actor_module_q-a_en.pdf

 

Here it states:

"4.5.1 Does Distributors need to register on EUDAMED?

The Distributors do not need to register and cannot register in EUDAMED. There is no actor role for distributor/wholesaler in EUDAMED and therefore no SRN for them."

 

Best Regards,

Stephanie

MedTechXperts GmbH
Jungenbergstrasse 7
CH-5023 Biberstein
Switzerland

sgrassmann@medtechxperts.com
info@medtechxperts.com
http://www.medtechxperts.com

 

Expediting Market Access & Ensuring the Success of Your Medical Device

------------------------------
Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 26-Aug-2021 10:32
From: Britta Cyron
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear all,

We are a manufacturer for class I and IIa Medical devices (among others TENS/EMS-Therapy). We manufacture and distribute our own devices. For this I needed under MDD a DIMDI-registration. Under MDR, I need a SRN from EUDAMED. To my knowledgde, I need 1 SRN as manufacturer.

We do also sell medical devices of other manufacturer, i.e. electrode gel, a class I medical device. The manufacturer asked me to sign a new distribution contract according to the requirements of the MDR. In this contract I have to state whether I need to register myself with local (German) compent authorities as distributor because this is would be differently handled in the different EU-member states.

This caught me kind of on the wrong foot, because I have studied the MDR and the German laws soley under the manufacturers point of view. I just started to depen my knowledge regarding EUDAMED-registration as well.

Can you help me answering the question whether I need to register as distributor in Germany?

Thank you!

Britta

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Hi Richard,

Thank you for pointing me to BfArM (should have been the obvious start for me to search *facepalm*).
I found my anwser. Since the devices are already sold somewhere else in EEC, I do not need to register. (German link).

Thank you all for your help!

It's always good to know that there are tons of people out there willing to help :-)

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------

Original Message:
Sent: 27-Aug-2021 05:20
From: Richard Vincins
Subject: MDR MAnufacturer and Distributor Registration Germany

Guten Tag Britta,

There was a previous post on this about distributor registration, indeed as others have said there is no Actor registration of distributors in EUDAMED.  If you look at Article 30 it states local authorities may implement registration requirements for distributors.  We understand there will be a few Member States doing this, requiring registration of distributors, to help with tracking of medical devices through the distribution chain.  I also do not know where any registration as a distributor is currently for Germany, but maybe would suggest contacting BfArM or your local office.  For me, this is going to be an important point of regulatory intelligence for manufacturers to understand which Member States require distributor registration.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 27-Aug-2021 03:10
From: Stephanie Grassmann
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear Britta,

 

The answer you can find black on white within the Actor registration module FAQ document at:

https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_actor_module_q-a_en.pdf

 

Here it states:

"4.5.1 Does Distributors need to register on EUDAMED?

The Distributors do not need to register and cannot register in EUDAMED. There is no actor role for distributor/wholesaler in EUDAMED and therefore no SRN for them."

 

Best Regards,

Stephanie

MedTechXperts GmbH
Jungenbergstrasse 7
CH-5023 Biberstein
Switzerland

sgrassmann@medtechxperts.com
info@medtechxperts.com
http://www.medtechxperts.com

 

Expediting Market Access & Ensuring the Success of Your Medical Device

------------------------------
Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 26-Aug-2021 10:32
From: Britta Cyron
Subject: MDR MAnufacturer and Distributor Registration Germany

Dear all,

We are a manufacturer for class I and IIa Medical devices (among others TENS/EMS-Therapy). We manufacture and distribute our own devices. For this I needed under MDD a DIMDI-registration. Under MDR, I need a SRN from EUDAMED. To my knowledgde, I need 1 SRN as manufacturer.

We do also sell medical devices of other manufacturer, i.e. electrode gel, a class I medical device. The manufacturer asked me to sign a new distribution contract according to the requirements of the MDR. In this contract I have to state whether I need to register myself with local (German) compent authorities as distributor because this is would be differently handled in the different EU-member states.

This caught me kind of on the wrong foot, because I have studied the MDR and the German laws soley under the manufacturers point of view. I just started to depen my knowledge regarding EUDAMED-registration as well.

Can you help me answering the question whether I need to register as distributor in Germany?

Thank you!

Britta

------------------------------
Britta Cyron
Quality Manager
Dorsten
Germany
------------------------------