Hello,
I was wondering what happens if you don't register as manufacturer in event of being virtual manufacturer, and sell the device under your name?
OEM has declared their MDSW as medical device under IVDD. Device falls in lowest class and does not require certification. They have all documentation and have registered the device in EU. We have agreement with them to be able to sell the device under our own brand. Technical. y, to sell under our own brand, we have to mark somewhere, who is the manufacturer.
I am wondering what happens if we would not label them as manufacturer. Since in this case, we would assume the role of the manufacturer, but we don't have the documentation (DoC, technical documentation,..) and registration of MDSW under our own name.
So I would assume we would be fined for put non-compliant device on the market. IVDR does not have fine, so probably by each country's local medical regulative?
How about future impact on the product. If just label original manufacturer on the device, we can continue the sales, or the sales are prohibited for fixed period of time, due to past non-compliance?
I was wondering what happens if you don't register as manufacturer in event of being virtual manufacturer, and sell the device under your name?
OEM has declared their MDSW as medical device under IVDD. Device falls in lowest class and does not require certification. They have all documentation and have registered the device in EU. We have agreement with them to be able to sell the device under our own brand. Technical. y, to sell under our own brand, we have to mark somewhere, who is the manufacturer.
I am wondering what happens if we would not label them as manufacturer. Since in this case, we would assume the role of the manufacturer, but we don't have the documentation (DoC, technical documentation,..) and registration of MDSW under our own name.
So I would assume we would be fined for put non-compliant device on the market. IVDR does not have fine, so probably by each country's local medical regulative?
How about future impact on the product. If just label original manufacturer on the device, we can continue the sales, or the sales are prohibited for fixed period of time, due to past non-compliance?
