Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Is a CE Mark required in order to sell into one European Union country?  For example if a company would like to sell in France, does it need to CE Mark or does France have its own registration process?  (for sales within France only )  and if so how would this be done?  
Thank you

Hi Anon

The short answer: Always CE mark your equipment if you want to sell in any EU-member country. 

The longer version: Do you know which class your equipment is? If it i class I in Europe you don't need a Notified Body right now, but you will in a few years as a consequence of MDR. If your equipment is class II or III you will need to work with a Notified Body to put a CE mark on your equipment.

Do you have a Legal Representative in EU? You need to have one and they will probably assist you in the process with obtaining the CE mark.

There is no easy solution, I am sorry to say. 

Best wishes for a smooth process

------------------------------
Dorthe Wallin
Regulatory Compliance Officer
Cortex Technology
Hadsund
Denmark
------------------------------

Original Message:
Sent: 06-Nov-2018 12:07
From: Anonymous Member
Subject: To CE Mark or not to CE Mark

This message was posted by a user wishing to remain anonymous

Is a CE Mark required in order to sell into one European Union country?  For example if a company would like to sell in France, does it need to CE Mark or does France have its own registration process?  (for sales within France only )  and if so how would this be done?
Thank you

As stated, this is why CE Mark is required - all countries that are part of the EU and EFTA require a CE Mark based on the type of device (not just medical devices) - will not get into the long explanation of legal requirements for CE marking and declaration of conformity.  Unfortunately what happened with the Medical Device Directive (MDD) 93/42/EEC is that countries did not have faith in the system so they implemented their own registration process knowing what products were placed on the market in their country.  The answer to your send question is that there are some countries that have a registration in place (and any Class I non-sterile, non-measuring) also need to be registered in almost all EU countries).  This is a short answer for long information and also really depends on the type of product.

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

Original Message:
Sent: 07-Nov-2018 04:37
From: Dorthe Wallin
Subject: To CE Mark or not to CE Mark

Hi Anon

The short answer: Always CE mark your equipment if you want to sell in any EU-member country.

The longer version: Do you know which class your equipment is? If it i class I in Europe you don't need a Notified Body right now, but you will in a few years as a consequence of MDR. If your equipment is class II or III you will need to work with a Notified Body to put a CE mark on your equipment.

Do you have a Legal Representative in EU? You need to have one and they will probably assist you in the process with obtaining the CE mark.

There is no easy solution, I am sorry to say.

Best wishes for a smooth process

------------------------------
Dorthe Wallin
Regulatory Compliance Officer
Cortex Technology
Hadsund
Denmark

Original Message:
Sent: 06-Nov-2018 12:07
From: Anonymous Member
Subject: To CE Mark or not to CE Mark

This message was posted by a user wishing to remain anonymous

Is a CE Mark required in order to sell into one European Union country?  For example if a company would like to sell in France, does it need to CE Mark or does France have its own registration process?  (for sales within France only )  and if so how would this be done?
Thank you

This message was posted by a user wishing to remain anonymous

Thank you for the information! so it sounds like CE Mark is always required and additionally some countries may have additional registration requirements of their own.
Original Message:
Sent: 07-Nov-2018 10:43
From: Richard Vincins
Subject: To CE Mark or not to CE Mark

As stated, this is why CE Mark is required - all countries that are part of the EU and EFTA require a CE Mark based on the type of device (not just medical devices) - will not get into the long explanation of legal requirements for CE marking and declaration of conformity.  Unfortunately what happened with the Medical Device Directive (MDD) 93/42/EEC is that countries did not have faith in the system so they implemented their own registration process knowing what products were placed on the market in their country.  The answer to your send question is that there are some countries that have a registration in place (and any Class I non-sterile, non-measuring) also need to be registered in almost all EU countries).  This is a short answer for long information and also really depends on the type of product.

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

Original Message:
Sent: 07-Nov-2018 04:37
From: Dorthe Wallin
Subject: To CE Mark or not to CE Mark

Hi Anon

The short answer: Always CE mark your equipment if you want to sell in any EU-member country.

The longer version: Do you know which class your equipment is? If it i class I in Europe you don't need a Notified Body right now, but you will in a few years as a consequence of MDR. If your equipment is class II or III you will need to work with a Notified Body to put a CE mark on your equipment.

Do you have a Legal Representative in EU? You need to have one and they will probably assist you in the process with obtaining the CE mark.

There is no easy solution, I am sorry to say.

Best wishes for a smooth process

------------------------------
Dorthe Wallin
Regulatory Compliance Officer
Cortex Technology
Hadsund
Denmark

Original Message:
Sent: 06-Nov-2018 12:07
From: Anonymous Member
Subject: To CE Mark or not to CE Mark

This message was posted by a user wishing to remain anonymous

Is a CE Mark required in order to sell into one European Union country?  For example if a company would like to sell in France, does it need to CE Mark or does France have its own registration process?  (for sales within France only )  and if so how would this be done?
Thank you

This message was posted by a user wishing to remain anonymous

Thank you for the information!
Original Message:
Sent: 07-Nov-2018 04:37
From: Dorthe Wallin
Subject: To CE Mark or not to CE Mark

Hi Anon

The short answer: Always CE mark your equipment if you want to sell in any EU-member country.

The longer version: Do you know which class your equipment is? If it i class I in Europe you don't need a Notified Body right now, but you will in a few years as a consequence of MDR. If your equipment is class II or III you will need to work with a Notified Body to put a CE mark on your equipment.

Do you have a Legal Representative in EU? You need to have one and they will probably assist you in the process with obtaining the CE mark.

There is no easy solution, I am sorry to say.

Best wishes for a smooth process

------------------------------
Dorthe Wallin
Regulatory Compliance Officer
Cortex Technology
Hadsund
Denmark

Original Message:
Sent: 06-Nov-2018 12:07
From: Anonymous Member
Subject: To CE Mark or not to CE Mark

This message was posted by a user wishing to remain anonymous

Is a CE Mark required in order to sell into one European Union country?  For example if a company would like to sell in France, does it need to CE Mark or does France have its own registration process?  (for sales within France only )  and if so how would this be done?
Thank you

To sell Medical devices in countries of the European Union (EU) and the European Economic Area (EEA) plus Switzerland they must bear the CE mark. In these countries there are no additional requirements for registrations. Since France is a member state of the EU your Medical devices must have the CE mark.


------------------------------
Oscar Banz
Head of QM & RA
Grenchen
Switzerland
------------------------------

Original Message:
Sent: 06-Nov-2018 12:07
From: Anonymous Member
Subject: To CE Mark or not to CE Mark

This message was posted by a user wishing to remain anonymous

Is a CE Mark required in order to sell into one European Union country?  For example if a company would like to sell in France, does it need to CE Mark or does France have its own registration process?  (for sales within France only )  and if so how would this be done?
Thank you

I like the short answer. 

Here is some additional information if useful; The CE marking is required only for products for which a CE marking directive or regulation has been adopted, a medical device is one of those products. 

Therefore in order to marked your medical device in the European Union, includes France, and yes depending on the classification of your product the procedure can be different, there is no mechanism that I am aware of for a country specific approval of a medical device for human use. 

However, I am willing to learn,

Good luck,

Dar 


------------------------------
Darlene Rosario MBA, RAC
Senior Vice President Regulatory Affairs and Compliance
Ventura CA
United States
------------------------------

Original Message:
Sent: 06-Nov-2018 12:07
From: Anonymous Member
Subject: To CE Mark or not to CE Mark

This message was posted by a user wishing to remain anonymous

Is a CE Mark required in order to sell into one European Union country?  For example if a company would like to sell in France, does it need to CE Mark or does France have its own registration process?  (for sales within France only )  and if so how would this be done?
Thank you