Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All,

We had recently received an e-mail from our EU notified body as follows:
- Ukraine certification body (judging from its web-site, it shall be a non-governmental body) directly contacted to EU notified body and they requested the "evidence" of our EC certificate of full quality assurance system. 
- It is for certification of our product applied to that certification body. 
  (Our dealer is taking care of the application and we don't know if they actually applied to that organization or not yet but it seems they are actually taking care of the application.)
- Evidence includes confirmation of the validity of EC certificate and conformity assessment document. 

And the notified body told us they will charge 3100 dollar if we want them to do that!

Could anybody have experienced something like this? 
We have previous experience on Ukraine application but something like this had never happened.

I had never heard something like this in any other country. 
Any suggestion, advice, or information would be highly appreciated!

Hello there,

I guess I am not following, does the EU Notified Body want 3,100 Euro for them to provide "evidence" of the certificate or is the Ukraine certification body asking for 3,100 Euro/Dollars for acceptance of the EC Certificate.  Also please keep in mind there are two certificates for the European Union: 1) EC Certificate which is for the product certification (tech doc review) and 2) QMS Certificate against the EU MDD/EU MDR which typically is included with the ISO 13485 certificate.  You should clarify exactly which certificate the Ukraine certification body wants.  Also, can you not work with your dealer to provide the EC Certificate/QMS Certificate yourself directly to the Ukraine certification body?  I personally have not seen something like this before, but does not surprise me.  When you have agencies in other countries requesting information it can be very challenging.

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

Original Message:
Sent: 18-Aug-2020 22:17
From: Anonymous Member
Subject: Ukraine certification body directly contacted to our notified body

This message was posted by a user wishing to remain anonymous

Dear All,

We had recently received an e-mail from our EU notified body as follows:
- Ukraine certification body (judging from its web-site, it shall be a non-governmental body) directly contacted to EU notified body and they requested the "evidence" of our EC certificate of full quality assurance system.
- It is for certification of our product applied to that certification body.
  (Our dealer is taking care of the application and we don't know if they actually applied to that organization or not yet but it seems they are actually taking care of the application.)
- Evidence includes confirmation of the validity of EC certificate and conformity assessment document.

And the notified body told us they will charge 3100 dollar if we want them to do that!

Could anybody have experienced something like this?
We have previous experience on Ukraine application but something like this had never happened.

I had never heard something like this in any other country.
Any suggestion, advice, or information would be highly appreciated!

This message was posted by a user wishing to remain anonymous

Thank you Richard for your advice.
It is EU notified body who told us "Ukraine certification body want the proof of EU quality system certificate and we can do it by 3100 dollar".  It was directly came from EU notified body before we hear anything from our dealer. We may contact to our dealer to figure out what is going on.
Original Message:
Sent: 20-Aug-2020 06:26
From: Richard Vincins
Subject: Ukraine certification body directly contacted to our notified body

Hello there,

I guess I am not following, does the EU Notified Body want 3,100 Euro for them to provide "evidence" of the certificate or is the Ukraine certification body asking for 3,100 Euro/Dollars for acceptance of the EC Certificate.  Also please keep in mind there are two certificates for the European Union: 1) EC Certificate which is for the product certification (tech doc review) and 2) QMS Certificate against the EU MDD/EU MDR which typically is included with the ISO 13485 certificate.  You should clarify exactly which certificate the Ukraine certification body wants.  Also, can you not work with your dealer to provide the EC Certificate/QMS Certificate yourself directly to the Ukraine certification body?  I personally have not seen something like this before, but does not surprise me.  When you have agencies in other countries requesting information it can be very challenging.

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

Original Message:
Sent: 18-Aug-2020 22:17
From: Anonymous Member
Subject: Ukraine certification body directly contacted to our notified body

This message was posted by a user wishing to remain anonymous

Dear All,

We had recently received an e-mail from our EU notified body as follows:
- Ukraine certification body (judging from its web-site, it shall be a non-governmental body) directly contacted to EU notified body and they requested the "evidence" of our EC certificate of full quality assurance system.
- It is for certification of our product applied to that certification body.
  (Our dealer is taking care of the application and we don't know if they actually applied to that organization or not yet but it seems they are actually taking care of the application.)
- Evidence includes confirmation of the validity of EC certificate and conformity assessment document.

And the notified body told us they will charge 3100 dollar if we want them to do that!

Could anybody have experienced something like this?
We have previous experience on Ukraine application but something like this had never happened.

I had never heard something like this in any other country.
Any suggestion, advice, or information would be highly appreciated!

This message was posted by a user wishing to remain anonymous

HI Anon,

yes, we have experienced the same request from the Ukraine.  Around 2015, the Ukraine NB requested to audit our facilities in order to maintain continued product sales in the Ukraine.  During our audit, we were told that they wanted to reach out directly to our EU NB to confirm continued ISO certification, or they would need to come back and audit us each subsequent year.  Interestingly enough, our EU NB, indicated that they would not respond to another NBs request, but that we could provide our audit report and renewed ISO certificate to them as evidence of continued compliance.  For the past 4 years, we have provided the report and ISO certificates directly to the Ukraine NB, without going through the EU NB, and have not had any further issues with the Ukraine.

Hope this helps with your situation as well.
Original Message:
Sent: 18-Aug-2020 22:17
From: Anonymous Member
Subject: Ukraine certification body directly contacted to our notified body

This message was posted by a user wishing to remain anonymous

Dear All,

We had recently received an e-mail from our EU notified body as follows:
- Ukraine certification body (judging from its web-site, it shall be a non-governmental body) directly contacted to EU notified body and they requested the "evidence" of our EC certificate of full quality assurance system.
- It is for certification of our product applied to that certification body.
  (Our dealer is taking care of the application and we don't know if they actually applied to that organization or not yet but it seems they are actually taking care of the application.)
- Evidence includes confirmation of the validity of EC certificate and conformity assessment document.

And the notified body told us they will charge 3100 dollar if we want them to do that!

Could anybody have experienced something like this?
We have previous experience on Ukraine application but something like this had never happened.

I had never heard something like this in any other country.
Any suggestion, advice, or information would be highly appreciated!

This message was posted by a user wishing to remain anonymous

Thank you so much for sharing your experience! 
We will ask the dealer about the situation keeping your information in our mind.
Original Message:
Sent: 21-Aug-2020 09:14
From: Anonymous Member
Subject: Ukraine certification body directly contacted to our notified body

This message was posted by a user wishing to remain anonymous

HI Anon,

yes, we have experienced the same request from the Ukraine.  Around 2015, the Ukraine NB requested to audit our facilities in order to maintain continued product sales in the Ukraine.  During our audit, we were told that they wanted to reach out directly to our EU NB to confirm continued ISO certification, or they would need to come back and audit us each subsequent year.  Interestingly enough, our EU NB, indicated that they would not respond to another NBs request, but that we could provide our audit report and renewed ISO certificate to them as evidence of continued compliance.  For the past 4 years, we have provided the report and ISO certificates directly to the Ukraine NB, without going through the EU NB, and have not had any further issues with the Ukraine.

Hope this helps with your situation as well.
Original Message:
Sent: 18-Aug-2020 22:17
From: Anonymous Member
Subject: Ukraine certification body directly contacted to our notified body

This message was posted by a user wishing to remain anonymous

Dear All,

We had recently received an e-mail from our EU notified body as follows:
- Ukraine certification body (judging from its web-site, it shall be a non-governmental body) directly contacted to EU notified body and they requested the "evidence" of our EC certificate of full quality assurance system.
- It is for certification of our product applied to that certification body.
  (Our dealer is taking care of the application and we don't know if they actually applied to that organization or not yet but it seems they are actually taking care of the application.)
- Evidence includes confirmation of the validity of EC certificate and conformity assessment document.

And the notified body told us they will charge 3100 dollar if we want them to do that!

Could anybody have experienced something like this?
We have previous experience on Ukraine application but something like this had never happened.

I had never heard something like this in any other country.
Any suggestion, advice, or information would be highly appreciated!

Hi Anon,

Does this EU NB have a database on its website to search the issued certificates? Most of the NBs do. If so, they can see it directly from the website.

It is very bizarre indeed.

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 18-Aug-2020 22:17
From: Anonymous Member
Subject: Ukraine certification body directly contacted to our notified body

This message was posted by a user wishing to remain anonymous

Dear All,

We had recently received an e-mail from our EU notified body as follows:
- Ukraine certification body (judging from its web-site, it shall be a non-governmental body) directly contacted to EU notified body and they requested the "evidence" of our EC certificate of full quality assurance system.
- It is for certification of our product applied to that certification body.
  (Our dealer is taking care of the application and we don't know if they actually applied to that organization or not yet but it seems they are actually taking care of the application.)
- Evidence includes confirmation of the validity of EC certificate and conformity assessment document.

And the notified body told us they will charge 3100 dollar if we want them to do that!

Could anybody have experienced something like this?
We have previous experience on Ukraine application but something like this had never happened.

I had never heard something like this in any other country.
Any suggestion, advice, or information would be highly appreciated!

This message was posted by a user wishing to remain anonymous

Thank you so much for the advice!
I found the database and will ask if it is sufficient or not!

Actually, I had long believed they don't have the database and I had not even looked for one. 
The NB developed it recently or I might had been simply wrong. 

Thanks again!
Original Message:
Sent: 25-Aug-2020 02:05
From: Spyros Drivelos
Subject: Ukraine certification body directly contacted to our notified body

Hi Anon,

Does this EU NB have a database on its website to search the issued certificates? Most of the NBs do. If so, they can see it directly from the website.

It is very bizarre indeed.

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 18-Aug-2020 22:17
From: Anonymous Member
Subject: Ukraine certification body directly contacted to our notified body

This message was posted by a user wishing to remain anonymous

Dear All,

We had recently received an e-mail from our EU notified body as follows:
- Ukraine certification body (judging from its web-site, it shall be a non-governmental body) directly contacted to EU notified body and they requested the "evidence" of our EC certificate of full quality assurance system.
- It is for certification of our product applied to that certification body.
  (Our dealer is taking care of the application and we don't know if they actually applied to that organization or not yet but it seems they are actually taking care of the application.)
- Evidence includes confirmation of the validity of EC certificate and conformity assessment document.

And the notified body told us they will charge 3100 dollar if we want them to do that!

Could anybody have experienced something like this?
We have previous experience on Ukraine application but something like this had never happened.

I had never heard something like this in any other country.
Any suggestion, advice, or information would be highly appreciated!