Regulatory Open Forum

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

Thank you, Stephanie for your questions.

Remember that "Actor" registration corresponds to the EUDAMED registration of Economic Operators.  Economic Operators include manufacturers, authorized representatives, importers, and distributors, though currently there is no distributor registration requirement (unless and until one is created for distributors pursuant to EU MDR Article 30(2).  Notified Bodies are not Economic Operators and are therefore outside the scope of Shikha's question and my prior response.

The second EUDAMED module (UDI/device registration) (as well as others to come later) are also outside the scope of the "Actor" registration topic about which Shikha is asking and to which my prior response applies.  It is important not to confuse the Actor registration module and requirements with the other five modules (e.g., those on UDI/Devices, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance).

A previous version of the website you linked and the Commission's supporting 30 October 2019 notice foresaw all modules launching by May 2022.  Presumably due to the COVID-19 pandemic, they have now softened (yet not necessarily amended) that language and are aiming for full implementation on a "gradual basis" and "as soon as they are functional" (see my prior website link and yours).  Nonetheless, such positions and notices have thus far been quite everchanging.  Ultimately, the current official legislative deadline is that represented by Articles 123(2) and 123(3)(d). As noted in my prior narrative, to be safe I'm currently suggesting that folks view, for the moment, that date to be May 2022 (all modules) and to be safer, May 2021, for the Actor module.  This is partially influenced by MDCG's MDCG 2020-15 bold language strongly encouraging actor registration.  However, to your point, I should have used softer language than "mandatory" regarding the Actor registration module, as aforesaid Articles 123(2) and 123(3)(d) currently leave undefined a definitive legislative deadline; thank you for requesting my associated clarification.  Happy New year to you also!

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Dear Kevin

Sorry, I disagree with your comment " mandatory registration deadline is May 26, 2021" and your follow-up comments with relation to this deadline.

With reference to my comments below, please refer to the consolidated version of the EU Medical Device Regulation (MDR), Articles 34 and 123.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424 

Here is a summary of the MDR Article 34 "Functionality of Eudamed" with sub-articles:

1. EC has to ensure "that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2021 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met"

         then

2. EUDAMED has to be verified that it has achieved full functionality and meets functional specifications according to Art 34(1)

        then

3. Commission consults with MDCG. If Commission satisfied referring to Art 34(2), then an official notice is published in Official Journal of the European Union

According to Article 123 " Entry into force and date of application"

"... the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3)" -> Article 34(3) is point 3 above.

Since, the Eudamed is:

• not fully functional,
• has not been verified
• no official notice has been published
• waiting time of 6 months has not started since the official notice - the trigger - has been published

then May 2021 cannot the deadline in my opinion.


Best Regards,
Stephanie

Thank you, Stephanie for your questions.

Remember that "Actor" registration corresponds to the EUDAMED registration of Economic Operators.  Economic Operators include manufacturers, authorized representatives, importers, and distributors, though currently there is no distributor registration requirement (unless and until one is created for distributors pursuant to EU MDR Article 30(2).  Notified Bodies are not Economic Operators and are therefore outside the scope of Shikha's question and my prior response.

The second EUDAMED module (UDI/device registration) (as well as others to come later) are also outside the scope of the "Actor" registration topic about which Shikha is asking and to which my prior response applies.  It is important not to confuse the Actor registration module and requirements with the other five modules (e.g., those on UDI/Devices, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance).

A previous version of the website you linked and the Commission's supporting 30 October 2019 notice foresaw all modules launching by May 2022.  Presumably due to the COVID-19 pandemic, they have now softened (yet not necessarily amended) that language and are aiming for full implementation on a "gradual basis" and "as soon as they are functional" (see my prior website link and yours).  Nonetheless, such positions and notices have thus far been quite everchanging.  Ultimately, the current official legislative deadline is that represented by Articles 123(2) and 123(3)(d). As noted in my prior narrative, to be safe I'm currently suggesting that folks view, for the moment, that date to be May 2022 (all modules) and to be safer, May 2021, for the Actor module.  This is partially influenced by MDCG's MDCG 2020-15 bold language strongly encouraging actor registration.  However, to your point, I should have used softer language than "mandatory" regarding the Actor registration module, as aforesaid Articles 123(2) and 123(3)(d) currently leave undefined a definitive legislative deadline; thank you for requesting my associated clarification.  Happy New year to you also!

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Dear Kevin

Sorry, I disagree with your comment " mandatory registration deadline is May 26, 2021" and your follow-up comments with relation to this deadline.

With reference to my comments below, please refer to the consolidated version of the EU Medical Device Regulation (MDR), Articles 34 and 123.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424 

Here is a summary of the MDR Article 34 "Functionality of Eudamed" with sub-articles:

1. EC has to ensure "that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2021 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met"

         then

2. EUDAMED has to be verified that it has achieved full functionality and meets functional specifications according to Art 34(1)

        then

3. Commission consults with MDCG. If Commission satisfied referring to Art 34(2), then an official notice is published in Official Journal of the European Union

According to Article 123 " Entry into force and date of application"

"... the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3)" -> Article 34(3) is point 3 above.

Since, the Eudamed is:

• not fully functional,
• has not been verified
• no official notice has been published
• waiting time of 6 months has not started since the official notice - the trigger - has been published

then May 2021 cannot the deadline in my opinion.


Best Regards,
Stephanie

Thank you, Stephanie for your questions.

Remember that "Actor" registration corresponds to the EUDAMED registration of Economic Operators.  Economic Operators include manufacturers, authorized representatives, importers, and distributors, though currently there is no distributor registration requirement (unless and until one is created for distributors pursuant to EU MDR Article 30(2).  Notified Bodies are not Economic Operators and are therefore outside the scope of Shikha's question and my prior response.

The second EUDAMED module (UDI/device registration) (as well as others to come later) are also outside the scope of the "Actor" registration topic about which Shikha is asking and to which my prior response applies.  It is important not to confuse the Actor registration module and requirements with the other five modules (e.g., those on UDI/Devices, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance).

A previous version of the website you linked and the Commission's supporting 30 October 2019 notice foresaw all modules launching by May 2022.  Presumably due to the COVID-19 pandemic, they have now softened (yet not necessarily amended) that language and are aiming for full implementation on a "gradual basis" and "as soon as they are functional" (see my prior website link and yours).  Nonetheless, such positions and notices have thus far been quite everchanging.  Ultimately, the current official legislative deadline is that represented by Articles 123(2) and 123(3)(d). As noted in my prior narrative, to be safe I'm currently suggesting that folks view, for the moment, that date to be May 2022 (all modules) and to be safer, May 2021, for the Actor module.  This is partially influenced by MDCG's MDCG 2020-15 bold language strongly encouraging actor registration.  However, to your point, I should have used softer language than "mandatory" regarding the Actor registration module, as aforesaid Articles 123(2) and 123(3)(d) currently leave undefined a definitive legislative deadline; thank you for requesting my associated clarification.  Happy New year to you also!

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Dear Kevin

Kindly request that you refer to MDR Article 34 "Functionality of Eudamed" and Article 123 " Entry into force and date of application" with regards to your question.
I apologize, I do not understand your question with regards to my posting. My posting states "no official notice has been published" (2nd last bullet).  

In summary, the European Commission will publish a notice in the Official Journal of the European Union when Eudamed has been verified and meets the defined functional specifications. Then there is 6 months - from the date of this publication - till obligations and requirements related to Eudamed are legally binding.  

At this point of time, many of the points of MDR Article 34 have not been fulfilled in addition to that no official notice has been published as referred to in Article 34(3).


Best Regards,
Stephanie

Dear Kevin

Sorry, I disagree with your comment " mandatory registration deadline is May 26, 2021" and your follow-up comments with relation to this deadline.

With reference to my comments below, please refer to the consolidated version of the EU Medical Device Regulation (MDR), Articles 34 and 123.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424 

Here is a summary of the MDR Article 34 "Functionality of Eudamed" with sub-articles:

1. EC has to ensure "that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2021 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met"

         then

2. EUDAMED has to be verified that it has achieved full functionality and meets functional specifications according to Art 34(1)

        then

3. Commission consults with MDCG. If Commission satisfied referring to Art 34(2), then an official notice is published in Official Journal of the European Union

According to Article 123 " Entry into force and date of application"

"... the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3)" -> Article 34(3) is point 3 above.

Since, the Eudamed is:

• not fully functional,
• has not been verified
• no official notice has been published
• waiting time of 6 months has not started since the official notice - the trigger - has been published

then May 2021 cannot the deadline in my opinion.


Best Regards,
Stephanie

Thank you, Stephanie for your questions.

Remember that "Actor" registration corresponds to the EUDAMED registration of Economic Operators.  Economic Operators include manufacturers, authorized representatives, importers, and distributors, though currently there is no distributor registration requirement (unless and until one is created for distributors pursuant to EU MDR Article 30(2).  Notified Bodies are not Economic Operators and are therefore outside the scope of Shikha's question and my prior response.

The second EUDAMED module (UDI/device registration) (as well as others to come later) are also outside the scope of the "Actor" registration topic about which Shikha is asking and to which my prior response applies.  It is important not to confuse the Actor registration module and requirements with the other five modules (e.g., those on UDI/Devices, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance).

A previous version of the website you linked and the Commission's supporting 30 October 2019 notice foresaw all modules launching by May 2022.  Presumably due to the COVID-19 pandemic, they have now softened (yet not necessarily amended) that language and are aiming for full implementation on a "gradual basis" and "as soon as they are functional" (see my prior website link and yours).  Nonetheless, such positions and notices have thus far been quite everchanging.  Ultimately, the current official legislative deadline is that represented by Articles 123(2) and 123(3)(d). As noted in my prior narrative, to be safe I'm currently suggesting that folks view, for the moment, that date to be May 2022 (all modules) and to be safer, May 2021, for the Actor module.  This is partially influenced by MDCG's MDCG 2020-15 bold language strongly encouraging actor registration.  However, to your point, I should have used softer language than "mandatory" regarding the Actor registration module, as aforesaid Articles 123(2) and 123(3)(d) currently leave undefined a definitive legislative deadline; thank you for requesting my associated clarification.  Happy New year to you also!

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

Thank you for the question and comment in regards to the actor registration.

It is clearly not a good approach of the EU to have the actor registration implemented on a voluntary basis.  In Germany we 130km/h on a voluntary basis!!!!

The actor registration is an important module for Eudamed and indeed it causes now significant problems.  The MDR states the whole Eudamed must be in place in order to make it mandatory.  This was done for a good reason.

1. The member states via the MDCG Group seemed to push for having the actor module available but there is no legal basis whatsoever in a Member State and someone should wonder why officials do something if they are not required to do so. Meaning without a legal basis the SRN issued up to now may simply not be valid.  That could change with a national law but be aware that the ministry of health currently have different problems to deal with then the SRN.
2. It already has been decided to delay Eudamed until May 2022. The MDR does have provision if Eudamed is delayed the IVDR does not have these provisions.  Therefore, the pressure is up.
3. Once Eudamed is fully in place (once published in the Official Journal of the EU) transitional provisions apply for the individual registration a manufacturer must perform).

The following applies on the application date and that cannot be changed that easily since it is written in the law in the MDR.  In general terms the fall back scenario in regards to the registration is the MDD and the actual transposition of the MDD in the Member States. This certainly makes sense.

Overall, we are not against this voluntary approach and recommend to use it, if possible.  However, please be aware as long there is no legal basis the MDD rules prevail and must be put in place.  Meaning even if you have a SRN you must follow the current registration rules which apply to you via your EC REP.

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

Thank you for the question and comment in regards to the actor registration.

It is clearly not a good approach of the EU to have the actor registration implemented on a voluntary basis.  In Germany we 130km/h on a voluntary basis!!!!

The actor registration is an important module for Eudamed and indeed it causes now significant problems.  The MDR states the whole Eudamed must be in place in order to make it mandatory.  This was done for a good reason.

1. The member states via the MDCG Group seemed to push for having the actor module available but there is no legal basis whatsoever in a Member State and someone should wonder why officials do something if they are not required to do so. Meaning without a legal basis the SRN issued up to now may simply not be valid.  That could change with a national law but be aware that the ministry of health currently have different problems to deal with then the SRN.
2. It already has been decided to delay Eudamed until May 2022. The MDR does have provision if Eudamed is delayed the IVDR does not have these provisions.  Therefore, the pressure is up.
3. Once Eudamed is fully in place (once published in the Official Journal of the EU) transitional provisions apply for the individual registration a manufacturer must perform).

The following applies on the application date and that cannot be changed that easily since it is written in the law in the MDR.  In general terms the fall back scenario in regards to the registration is the MDD and the actual transposition of the MDD in the Member States. This certainly makes sense.

Overall, we are not against this voluntary approach and recommend to use it, if possible.  However, please be aware as long there is no legal basis the MDD rules prevail and must be put in place.  Meaning even if you have a SRN you must follow the current registration rules which apply to you via your EC REP.

1 December 2020 marked the first day that we can voluntarily register as "Actors" in the new EUDAMED database as part of the transition to the new EU MDR.  Though we can voluntarily register as of 1 December 2020, note that the mandatory registration deadline is May 26, 2021 with a possibility that it might be delayed further until 26 May 2022.  For now I recommend aiming for May 26, 2021 at the latest.  Visit https://ec.europa.eu/health/md_eudamed/actors_registration_en for further details about the Actor registration process.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Just an extra note to this discussion, with regards to actor registration:

Please note that only operators from the following countries are allowed to register in the Eudamed Actor module since December 2020: those established within "EU 27, Iceland, Liechtenstein and Norway".

Economic operators from the following countries are not allowed to register according to the Actor Module FAQs document:

• UK
• Switzerland
• Turkey
• USA

For further information please consult the Actor Module FAQs at the following web site

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

Best Regards,

Stephanie

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

Original Message:
Sent: 30-Dec-2020 03:31
From: Shikha Malik
Subject: EUDAMED Actor registration module

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

Just an extra note to this discussion, with regards to actor registration:

Please note that only operators from the following countries are allowed to register in the Eudamed Actor module since December 2020: those established within "EU 27, Iceland, Liechtenstein and Norway".

Economic operators from the following countries are not allowed to register according to the Actor Module FAQs document:

• UK
• Switzerland
• Turkey
• USA

For further information please consult the Actor Module FAQs at the following web site

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

Best Regards,

Stephanie

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

Original Message:
Sent: 30-Dec-2020 03:31
From: Shikha Malik
Subject: EUDAMED Actor registration module

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

------------------------------
Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
------------------------------

Dear Richard,
thank you for your comment in regards to EU.

There are aspects, which will not be regulated in the EU since there are cultural issues.  The regulation was written for the EU not necessarily focusing on manufacturers outside the EU.

If that is understood, there is no need to have a harmonized system for fees or penalties in place.  The fees apply where the manufacturer is located and he goes to jail where he is located. A manufacturer only needs to know the rules of his country.

We understand that for a manufacturer outside the EU the point of view is different.  For exmaple, It may be a factor to decide where his EC REP will be located concerning such fees. However,

1. Governmental registration fees should only reflect the resources used.
2. Consequently, they should not play a big role considering the overall cost of the MDR.

The last point is that you may select a country today with no fees and guess what it may change tomorrow. 

The UK always had registration fees and will keep them up after the Brexit!  This has not prevented the UK being the country with the most EC REPS in the past.

Hello all,

I heard about that the European Commission has made available the EUDAMED Actor registration module for voluntary use by Member States and Economic operators as of Dec 1, 2020. May I please ask if any one has any relevant details about this communication?

Also, how does a manufacturer is impacted by this upcoming regulation ? Is there any action required for lower classes devices such as class I?

Thank you all in advance.

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Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
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