The European Partner Certification - To Be or Not To Be

M

Manager

Hi Folks!
Thank you for the Great forum, many useful answers I have been receiving from very competent specialists.

We are the manufacturers of medical devices (EEG, not sterile devices) from Russia. Our QMS conforms requirements of ISO 13485 & 93/42/EEC (CE-marking).

The certificated processes:
1. Design & Development,
2. Production
3. Final inspection
4. Service maintenance
5. Sales

The majority of devices we sale outside Russia at present, nevertheless we have to get all licenses and registrations in numerous State departments, that are not needed in EU and bear us a lot of time and money.:nopity:
We decide to deal with our partners in Europe concerning manufacturing of our devices.
In this respect I’d like to ask: How is it better, simpler and cheaper to do certification by ISO 13485 & 93/42/EEC (CE-marking)? Whether it is necessary to certificate European partner at all.

I suppose: we can determine processes «Manufacturing» and «Final inspection» as the outsourcing processes (for the devices, which we’ll sale in Europe). I see the following variants:

NOT TO CERTIFICATE European partner according to 13485 and CE, but to demonstrate our managing possibilities in outsourcing processes of European partner during QMS external(surveillance) audit in Russia. After the device is produced, Russian department sends the device Declaration of conformity to European partner in order to sale device in Europe.

TO CERTIFICATE European partner:
a. To get ISO 13485 and CE in European department for processes «Manufacturing» and «Final inspection» or ONLY for «Final inspection» process. European department processes Declaration of conformity for the device by itself, because it has 13485 and CE.
b. To get CE in European department for processes «Manufacturing» and «Final inspection» or ONLY for «Final inspection» process (accreditation of Testing laboratory). European department processes Declaration of conformity for the device by itself, because it has CE.

Another question is how to manage the European users reclamations (device malfunctions), e.g. when the problem of device concerns design defect. Design and development department(D&DD) is situated in Russia. Must it be any form of detailed description of the problem for D&DD or shipping of broken device to the D&DD department in Russia?

Perhaps anybody has such experience?
Thank everybody in advance! :)
 
Last edited by a moderator:
somashekar

somashekar

Leader
Admin
Manager said:
Hi Folks!
Thank you for the Great forum, many useful answers I have been receiving from very competent specialists.

We are the manufacturers of medical devices (EEG, not sterile devices) from Russia. Our QMS conforms requirements of ISO 13485 & 93/42/EEC (CE-marking).

The certificated processes:
1. Design & Development,
2. Production
3. Final inspection
4. Service maintenance
5. Sales

The majority of devices we sale outside Russia at present, nevertheless we have to get all licenses and registrations in numerous State departments, that are not needed in EU and bear us a lot of time and money.:nopity:
We decide to deal with our partners in Europe concerning manufacturing of our devices.
In this respect I’d like to ask: How is it better, simpler and cheaper to do certification by ISO 13485 & 93/42/EEC (CE-marking)? Whether it is necessary to certificate European partner at all.

I suppose: we can determine processes «Manufacturing» and «Final inspection» as the outsourcing processes (for the devices, which we’ll sale in Europe). I see the following variants:

NOT TO CERTIFICATE European partner according to 13485 and CE, but to demonstrate our managing possibilities in outsourcing processes of European partner during QMS external(surveillance) audit in Russia. After the device is produced, Russian department sends the device Declaration of conformity to European partner in order to sale device in Europe.

TO CERTIFICATE European partner:
a. To get ISO 13485 and CE in European department for processes «Manufacturing» and «Final inspection» or ONLY for «Final inspection» process. European department processes Declaration of conformity for the device by itself, because it has 13485 and CE.
b. To get CE in European department for processes «Manufacturing» and «Final inspection» or ONLY for «Final inspection» process (accreditation of Testing laboratory). European department processes Declaration of conformity for the device by itself, because it has CE.

Another question is how to manage the European users reclamations (device malfunctions), e.g. when the problem of device concerns design defect. Design and development department(D&DD) is situated in Russia. Must it be any form of detailed description of the problem for D&DD or shipping of broken device to the D&DD department in Russia?

Perhaps anybody has such experience?
Thank everybody in advance! :)
Click to expand...
Hi Manager., Welcome here.
Your question has two issues, regulatory and business process, and they are interlinked.
While you are the manufacturer per the MDD, you can work to have the CE mark on your device (The passport for placing your medical device in the EU) with outsourcing of critical processes.
When you outsource your manufacturing process, please be aware that the factory which manufactures your device (contract manufacturer) can come under the CE notified body audit scope, and for this your good selection of the contract manufacturer and your agreement for manufacturing per your design and there readyness and willingness to take up the MDD audit is critical to the process. He being an ISO 13485 contract manufacturer is a very good criteria for your selection of the contract manufacturer.
Again since you are the manufacturer and being outside the EU, you are obligated to appoint an EU rep who will perform various tasks on your behalf and his name and address will appear on your device label, along with yours. It will also be your declaration of conformity for your product to the EU market.
You can appoint dealers for sales and service maintenance who can be selected by you based on your business process. You will again have the procedure for reclamation within your MDD scope that will be managed along with your selected dealer/s and your EU rep will pitch in when necessary.
Not to certificate process is perhaps the Own Brand Label (OBL) CE which any of your dealer / manufacturer can work towards, and this will always piggyback on your CE. Your notified body can easily work with your selected business partner to provide them with the OBL CE and then he becomes the manufacturer and you no more appear as manufacturer on the label. He also declares this by way of his declaration of conformity. You are responsible to maintain your QMS and the CE so that your business partner can get the devices and place them in the EU market as his device. A very good OBL agreement must be struck with your partner for this, which the notified body can honour.
 
Last edited:
M

Manager

Harry and Somashekar!
Thank you greatly for your helpful responses!
 
M

Manager

somashekar said:
When you outsource your manufacturing process, please be aware that the factory which manufactures your device (contract manufacturer) can come under the CE notified body audit scope
Click to expand...
can or must?

becouse gwaikle wrote here:
gwaikle said:
The fact is that there is no requirement for your supplier to meet the MDD requirements, it is yours and yours only since they will be manufacturing the devices for you with your CE Mark on the device. If they are a contract medical device manufacturer as you implied they should be Certified to ISO 13485: 2003 to satisfy their customer's requirements, but if they don't sell anything directly to and end user some clauses may not apply such as design.
Click to expand...

It means that our contract manufacturer mustn't fulfil requirements of MDD, but must fulfil requirements of ISO 13485:2003.
What normative document tells us about this?

somashekar said:
Not to certificate process is perhaps the Own Brand Label (OBL) CE which any of your dealer / manufacturer can work towards, and this will always piggyback on your CE.
Click to expand...
Do you mean OBL (Own Brand Label) = PLM (Private Label Manufacturer) according to the attached document?

somashekar said:
You are responsible to maintain your QMS and the CE so that your business partner can get the devices and place them in the EU market as his device.
Click to expand...
Do you mean audits and another revises of contract manufacturer performed by us?

Concerning posts on the other thread:
Al Rosen said:
Who signs the Declaration of Conformity? He will be the guy on the hook. Remind him. That's what I do.
Click to expand...
and then
celeo said:
It does not matter where the components of a medical device are designed, assembled, tested, packaged and/or sterilised.
The person who puts it onto the market under their own name (i.e. the MDD "manufacturer") is responsible for the safety and efficacy of the device, operator and patient.
Click to expand...
is the following possible?:
1. We (manufacturer with CE and ISO 13485:2003 in Russia) produce devices at contract manufacturer in EU that has no certificates (MDD and ISO 13485:2003),
2. make testings of devices (produced by contract manufacturer) at some famous and admitted in European union testing laboratory and get the «test laboratory conclusion» (which is sent to Russia),
3. according to the «test laboratory conclusion» we make the «Declaration of conformity» and send it to European dealer,
4. forward the devices with «Declaration of conformity» to the European dealer for purchasing.

Thank everybody in advance! :)
 
Last edited by a moderator:
You must log in or register to reply here.
Top Bottom