M
max898
Hi all,
I read the many thread about virtual manufacturing of medical devices but could not find the straight answer i was looking for. Maybe starting this thread will help closing once and for all the subject !
My company is going to commercialise medical devices class IIa in the EU. The devices are produced by an OEM. The OEM own all necessary certifications for commercialising the product in the EU.
The only element that the OEM is modifying vs. his usual product is the carton box containing the product. The box is using our own design.
So reading through the forum and through my own research i could find out this different possibilities:
1. My company is a virtual manufacturer and needs to go through the certifcation procedure with a company like TUV.
2. My company is a re-seller and no need of certification as we are only reselling the product of the OEM.
3. from this thread: Virtual manufacturers/OEM - CE/ISO requirements
"If you want to put your company name/trademark on product but use the CE marking of OEM that can we done. As you mentioned that OEM has already CE marking I assume the devices are above class I and requiring conformity assesment by notified body. In this case before putting the "manufactured by" on product the OEM company needs to make an scope extension application to his CE notified body and include your company name/trademark (in case the NB indicate it on certificate etc.) and product codes into their scope. "
what is the correct one? and what does this imply in terms of work to be compliant?
thanks!
I read the many thread about virtual manufacturing of medical devices but could not find the straight answer i was looking for. Maybe starting this thread will help closing once and for all the subject !
My company is going to commercialise medical devices class IIa in the EU. The devices are produced by an OEM. The OEM own all necessary certifications for commercialising the product in the EU.
The only element that the OEM is modifying vs. his usual product is the carton box containing the product. The box is using our own design.
So reading through the forum and through my own research i could find out this different possibilities:
1. My company is a virtual manufacturer and needs to go through the certifcation procedure with a company like TUV.
2. My company is a re-seller and no need of certification as we are only reselling the product of the OEM.
3. from this thread: Virtual manufacturers/OEM - CE/ISO requirements
"If you want to put your company name/trademark on product but use the CE marking of OEM that can we done. As you mentioned that OEM has already CE marking I assume the devices are above class I and requiring conformity assesment by notified body. In this case before putting the "manufactured by" on product the OEM company needs to make an scope extension application to his CE notified body and include your company name/trademark (in case the NB indicate it on certificate etc.) and product codes into their scope. "
what is the correct one? and what does this imply in terms of work to be compliant?
thanks!
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