Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Seeking advice related to selling a self-declare class I IVD in France. In a past life I learned from LNE G-MED that ANSM had a local requirement to notify them prior to commercializing the device and that we needed to appoint a local in-country Vigilance representative.

Does anyone have experience with this or know the specific laws that spell out this particular requirement. In searching the archives I noticed this question had been asked in years past, but to no avail. Hoping someone can offer up some advice.

Thank you in advance.

Good morning,

I worked for a French IVD company many years ago and indeed you had to register not only self-declare Class I IVDs but even other medical devices.  If I remember there was a list of devices or even any medical device which needed to be registered in France (ANSM).  Even up to a few years ago I understood this was still required, but we always had the local affiliate managing and registering.  This was the issue why we now have the EU MDR and EUDAMED because other countries would create their own local requirements for registrations or requirements for devices.  There was also the requirement for IVD manufacturers located in France to have a Pharmacia Responsible in the company similar to what the Person Responsible for Regulatory Compliance is now.

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

Original Message:
Sent: 09-Nov-2020 22:05
From: Anonymous Member
Subject: ANSM requirement for in-country vigilance rep

This message was posted by a user wishing to remain anonymous

Hello,

Seeking advice related to selling a self-declare class I IVD in France. In a past life I learned from LNE G-MED that ANSM had a local requirement to notify them prior to commercializing the device and that we needed to appoint a local in-country Vigilance representative.

Does anyone have experience with this or know the specific laws that spell out this particular requirement. In searching the archives I noticed this question had been asked in years past, but to no avail. Hoping someone can offer up some advice.

Thank you in advance.

This message was posted by a user wishing to remain anonymous

Hello,
I worked, in a previous life in French IVD industry.
For Europe according to directive 98/79/EC:
1. You must have an authorized representative in Europe if you are a manufacturer located outside Europe, and you must declare all your CE marked devices to an European Competent Authority (in principle the one where your authorized representative is located).
2. For France your authorized representative will have to declare himself to the ANSM, he will also have to indicate which type of products he markets in France (Article R.5221-3 of the Public Health Code: "Any person who engages in the manufacture, marketing, distribution, import or export, even on an incidental basis, of in vitro diagnostic medical devices must declare himself to the French Health Products Safety Agency, indicating the devices that are the object of his activity"), furthermore your distributor in France (and your importer, if he is in France) will have to declare himself.
For the vigilance (reactovigilance), Article R5222-11 of the Public Health Code: "Any manufacturer of in vitro diagnostic medical devices, or its (authorized) representative, shall designate a person in charge of reactovigilance, whose identity and quality shall be communicated to the Director General of the National Agency for the Safety of Medicines and Health Products.
For your information, I enclose the French explanatory documents that I have translated (so the translation is absolutely not official).
I hope these explanations are clear and will answer your question.
https://www.ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DMDIV-Declaration/(offset)/10
Original Message:
Sent: 09-Nov-2020 22:05
From: Anonymous Member
Subject: ANSM requirement for in-country vigilance rep

This message was posted by a user wishing to remain anonymous

Hello,

Seeking advice related to selling a self-declare class I IVD in France. In a past life I learned from LNE G-MED that ANSM had a local requirement to notify them prior to commercializing the device and that we needed to appoint a local in-country Vigilance representative.

Does anyone have experience with this or know the specific laws that spell out this particular requirement. In searching the archives I noticed this question had been asked in years past, but to no avail. Hoping someone can offer up some advice.

Thank you in advance.

Greatly appreciated, very helpful, thank you both.

------------------------------
Tweed Hanusek
Seattle WA
United States
------------------------------

Original Message:
Sent: 11-Nov-2020 09:59
From: Anonymous Member
Subject: ANSM requirement for in-country vigilance rep

This message was posted by a user wishing to remain anonymous

Hello,
I worked, in a previous life in French IVD industry.
For Europe according to directive 98/79/EC:
1. You must have an authorized representative in Europe if you are a manufacturer located outside Europe, and you must declare all your CE marked devices to an European Competent Authority (in principle the one where your authorized representative is located).
2. For France your authorized representative will have to declare himself to the ANSM, he will also have to indicate which type of products he markets in France (Article R.5221-3 of the Public Health Code: "Any person who engages in the manufacture, marketing, distribution, import or export, even on an incidental basis, of in vitro diagnostic medical devices must declare himself to the French Health Products Safety Agency, indicating the devices that are the object of his activity"), furthermore your distributor in France (and your importer, if he is in France) will have to declare himself.
For the vigilance (reactovigilance), Article R5222-11 of the Public Health Code: "Any manufacturer of in vitro diagnostic medical devices, or its (authorized) representative, shall designate a person in charge of reactovigilance, whose identity and quality shall be communicated to the Director General of the National Agency for the Safety of Medicines and Health Products.
For your information, I enclose the French explanatory documents that I have translated (so the translation is absolutely not official).
I hope these explanations are clear and will answer your question.
https://www.ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DMDIV-Declaration/(offset)/10
Original Message:
Sent: 09-Nov-2020 22:05
From: Anonymous Member
Subject: ANSM requirement for in-country vigilance rep

This message was posted by a user wishing to remain anonymous

Hello,

Seeking advice related to selling a self-declare class I IVD in France. In a past life I learned from LNE G-MED that ANSM had a local requirement to notify them prior to commercializing the device and that we needed to appoint a local in-country Vigilance representative.

Does anyone have experience with this or know the specific laws that spell out this particular requirement. In searching the archives I noticed this question had been asked in years past, but to no avail. Hoping someone can offer up some advice.

Thank you in advance.

Hi Tweed, 

Both Richard & the other post are correct, although there is a slight clarification needed and will depend on how you are planning to sell in France (by what channels). 
Basically, there a requirement to complete the Reactovigilance representative however only for the Manufacturer & authorised rep. (ie fabricants et mandataires). 
If you need to clarify anything else with ANSM let me know. 

Thanks 

Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Original Message:
Sent: 11-Nov-2020 16:58
From: Tweed Hanusek
Subject: ANSM requirement for in-country vigilance rep

Greatly appreciated, very helpful, thank you both.

------------------------------
Tweed Hanusek
Seattle WA
United States

Original Message:
Sent: 11-Nov-2020 09:59
From: Anonymous Member
Subject: ANSM requirement for in-country vigilance rep

This message was posted by a user wishing to remain anonymous

Hello,
I worked, in a previous life in French IVD industry.
For Europe according to directive 98/79/EC:
1. You must have an authorized representative in Europe if you are a manufacturer located outside Europe, and you must declare all your CE marked devices to an European Competent Authority (in principle the one where your authorized representative is located).
2. For France your authorized representative will have to declare himself to the ANSM, he will also have to indicate which type of products he markets in France (Article R.5221-3 of the Public Health Code: "Any person who engages in the manufacture, marketing, distribution, import or export, even on an incidental basis, of in vitro diagnostic medical devices must declare himself to the French Health Products Safety Agency, indicating the devices that are the object of his activity"), furthermore your distributor in France (and your importer, if he is in France) will have to declare himself.
For the vigilance (reactovigilance), Article R5222-11 of the Public Health Code: "Any manufacturer of in vitro diagnostic medical devices, or its (authorized) representative, shall designate a person in charge of reactovigilance, whose identity and quality shall be communicated to the Director General of the National Agency for the Safety of Medicines and Health Products.
For your information, I enclose the French explanatory documents that I have translated (so the translation is absolutely not official).
I hope these explanations are clear and will answer your question.
https://www.ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DMDIV-Declaration/(offset)/10
Original Message:
Sent: 09-Nov-2020 22:05
From: Anonymous Member
Subject: ANSM requirement for in-country vigilance rep

This message was posted by a user wishing to remain anonymous

Hello,

Seeking advice related to selling a self-declare class I IVD in France. In a past life I learned from LNE G-MED that ANSM had a local requirement to notify them prior to commercializing the device and that we needed to appoint a local in-country Vigilance representative.

Does anyone have experience with this or know the specific laws that spell out this particular requirement. In searching the archives I noticed this question had been asked in years past, but to no avail. Hoping someone can offer up some advice.

Thank you in advance.