Regulatory Open Forum

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Hi Shailesh

I haven't seen a list. You may need to search for each country of interest.

Here is the information for Italy:
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=5715&area=dispositivi-medici&menu=registrazione&tab=1

There are links for Finland, Ireland, and Portugal in this thread:
https://connect.raps.org/discussion/ce-mark-product-require-individual-eu-country-registration

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=a27c6d2c-e368-420f-a3dd-3bd65d20d8d8&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&bm=a27c6d2c-e368-420f-a3dd-3bd65d20d8d8

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Shailesh.

The whole premise and intent of the EU MDR 2017/745 was to remove the requirement for individual country registrations which became common under the EU MDD.  The EU MDR as a regulation applies to all countries and individual Member States are not supposed to impose requirements which go against or not supported by the regulation, i.e. individual country registrations.  In addition, with the establishment of EUDAMED now under the EU MDR both Economic Operators and product certificates will be completed by Manufacturers showing who and what is sold and placed on the market.  To answer your question, I know there were individual country registrations under the EU MDD, e.g. France or Italy, but I have not heard if this is continuing under the EU MDR (which it should not).

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 16-Sep-2022 09:20
From: Anne LeBlanc
Subject: CE marked device register separately (locally) in EU countries?

Hi Shailesh

I haven't seen a list. You may need to search for each country of interest.

Here is the information for Italy:
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=5715&area=dispositivi-medici&menu=registrazione&tab=1

There are links for Finland, Ireland, and Portugal in this thread:
https://connect.raps.org/discussion/ce-mark-product-require-individual-eu-country-registration

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=a27c6d2c-e368-420f-a3dd-3bd65d20d8d8&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&bm=a27c6d2c-e368-420f-a3dd-3bd65d20d8d8

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Hello,

Therefor you still have the national laws that can ask for additional questions.

Under MDD this was quite logical, as this was a European guidance which was then translated into the national laws.

Now under MDR, which is in fact a European law, this was normally nit the intention, but unfortunately it is still the case.

Therefor we have (as far a I know) the need to register in Bulgaria (Class I only),  Estonia, Finland (depending on product type), Italy, Latvia, Lithuania, Portugal, Slovakia (not for class I products) and Spain (for procedure packs)

Greetings,

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Hi Shailesh,

in countries like Bulgaria, Croatia, Estonia, Greece, Italy, Portugal, Spain, Slovakia, Poland and France the devices must be registeted at lokal Authority even if the device is already CE marked. 
In France you can register the devices directly without involving in it your local partner. There must be filled an application form out and send via email together  with the French IFU and product labels to ANSM (see template: http://www.cnifpd.fr/CNIFPD_v2/pdf/formulaire_fabricants.pdf).
It takes usually few months to receive a confirmation from ANSM. 

Regards,



------------------------------
Agnieszka Fronczak
Regulatory Affairs Manager
Neu-Ulm
Germany
------------------------------

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

The Italian MoH has indicated that their requirement is temporary, until EUDAMED is fully functional. Not sure about the other requirements.

The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the procedures foreseen by the MDR until the European Database on Medical Devices - Eudamed - is fully functional. In this context, in order to meet registration obligations in Italy it is required the registration in the national database.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 19-Sep-2022 03:33
From: Agnieszka Fronczak
Subject: CE marked device register separately (locally) in EU countries?

Hi Shailesh,

in countries like Bulgaria, Croatia, Estonia, Greece, Italy, Portugal, Spain, Slovakia, Poland and France the devices must be registeted at lokal Authority even if the device is already CE marked.
In France you can register the devices directly without involving in it your local partner. There must be filled an application form out and send via email together  with the French IFU and product labels to ANSM (see template: http://www.cnifpd.fr/CNIFPD_v2/pdf/formulaire_fabricants.pdf).
It takes usually few months to receive a confirmation from ANSM.

Regards,



------------------------------
Agnieszka Fronczak
Regulatory Affairs Manager
Neu-Ulm
Germany

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Hi Anne, Richard, Frankie and Agnieszka,

Many thanks for your replies, appreciate your help. 

It seems quite clear that we would need to pretty much register separately in the major EU countries at least until EUDAMED is fully functional which no one knows when.

And that would perhaps also mean extra registration costs every year..






------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Original Message:
Sent: 19-Sep-2022 10:30
From: Anne LeBlanc
Subject: CE marked device register separately (locally) in EU countries?

The Italian MoH has indicated that their requirement is temporary, until EUDAMED is fully functional. Not sure about the other requirements.

The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the procedures foreseen by the MDR until the European Database on Medical Devices - Eudamed - is fully functional. In this context, in order to meet registration obligations in Italy it is required the registration in the national database.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 19-Sep-2022 03:33
From: Agnieszka Fronczak
Subject: CE marked device register separately (locally) in EU countries?

Hi Shailesh,

in countries like Bulgaria, Croatia, Estonia, Greece, Italy, Portugal, Spain, Slovakia, Poland and France the devices must be registeted at lokal Authority even if the device is already CE marked.
In France you can register the devices directly without involving in it your local partner. There must be filled an application form out and send via email together  with the French IFU and product labels to ANSM (see template: http://www.cnifpd.fr/CNIFPD_v2/pdf/formulaire_fabricants.pdf).
It takes usually few months to receive a confirmation from ANSM.

Regards,



------------------------------
Agnieszka Fronczak
Regulatory Affairs Manager
Neu-Ulm
Germany

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Hello - 
Yes, I too agree that member states DO have the right to request additional information and I find that all the time in my research. The CE Mark allows for a smoother passing across the member state boarders, but it doesn't mean one registration process for all. 

Wouldn't that be an RA's dream come true!?! (insert big grin here)

------------------------------
Beth Lentz
Pittsburgh PA
United States
------------------------------

Original Message:
Sent: 20-Sep-2022 11:38
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi Anne, Richard, Frankie and Agnieszka,

Many thanks for your replies, appreciate your help.

It seems quite clear that we would need to pretty much register separately in the major EU countries at least until EUDAMED is fully functional which no one knows when.

And that would perhaps also mean extra registration costs every year..






------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom

Original Message:
Sent: 19-Sep-2022 10:30
From: Anne LeBlanc
Subject: CE marked device register separately (locally) in EU countries?

The Italian MoH has indicated that their requirement is temporary, until EUDAMED is fully functional. Not sure about the other requirements.

The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the procedures foreseen by the MDR until the European Database on Medical Devices - Eudamed - is fully functional. In this context, in order to meet registration obligations in Italy it is required the registration in the national database.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 19-Sep-2022 03:33
From: Agnieszka Fronczak
Subject: CE marked device register separately (locally) in EU countries?

Hi Shailesh,

in countries like Bulgaria, Croatia, Estonia, Greece, Italy, Portugal, Spain, Slovakia, Poland and France the devices must be registeted at lokal Authority even if the device is already CE marked.
In France you can register the devices directly without involving in it your local partner. There must be filled an application form out and send via email together  with the French IFU and product labels to ANSM (see template: http://www.cnifpd.fr/CNIFPD_v2/pdf/formulaire_fabricants.pdf).
It takes usually few months to receive a confirmation from ANSM.

Regards,



------------------------------
Agnieszka Fronczak
Regulatory Affairs Manager
Neu-Ulm
Germany

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------

Hi,
as per my experience, in whole European Union, some Countries require national registration, notwithstanding they are aligned with MDR and IVDR. I mean Rumania, Poland, Slovakia, Bulgaria, Spain etc. Sometimes it may be a simple notification without approval from the Competent Authority, sometimes a real registration.
On the other hand, many Countries, such as Denmark, Germany, Netherlands, etc. don't require any registration or notification.

Hope it was helpful for you.
Best regards

------------------------------
Valentina Faziani
Regulatory Affairs Specialist
Thema s.r.l.
Italy
------------------------------

Original Message:
Sent: 20-Sep-2022 11:38
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi Anne, Richard, Frankie and Agnieszka,

Many thanks for your replies, appreciate your help.

It seems quite clear that we would need to pretty much register separately in the major EU countries at least until EUDAMED is fully functional which no one knows when.

And that would perhaps also mean extra registration costs every year..






------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom

Original Message:
Sent: 19-Sep-2022 10:30
From: Anne LeBlanc
Subject: CE marked device register separately (locally) in EU countries?

The Italian MoH has indicated that their requirement is temporary, until EUDAMED is fully functional. Not sure about the other requirements.

The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the procedures foreseen by the MDR until the European Database on Medical Devices - Eudamed - is fully functional. In this context, in order to meet registration obligations in Italy it is required the registration in the national database.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 19-Sep-2022 03:33
From: Agnieszka Fronczak
Subject: CE marked device register separately (locally) in EU countries?

Hi Shailesh,

in countries like Bulgaria, Croatia, Estonia, Greece, Italy, Portugal, Spain, Slovakia, Poland and France the devices must be registeted at lokal Authority even if the device is already CE marked.
In France you can register the devices directly without involving in it your local partner. There must be filled an application form out and send via email together  with the French IFU and product labels to ANSM (see template: http://www.cnifpd.fr/CNIFPD_v2/pdf/formulaire_fabricants.pdf).
It takes usually few months to receive a confirmation from ANSM.

Regards,



------------------------------
Agnieszka Fronczak
Regulatory Affairs Manager
Neu-Ulm
Germany

Original Message:
Sent: 16-Sep-2022 06:52
From: Shailesh Joshi
Subject: CE marked device register separately (locally) in EU countries?

Hi,

Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?

There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?

Can someone guide on this and preferably point in the direction with a list of such countries?

Thank you

------------------------------
Shailesh Joshi
Regulatory Manager
Guildford
United Kingdom
------------------------------