Do you have a case where the concept of placing on the market is key for your EU Medical Device Industry Strategy? For example for Class I products that need to be placed on the market before May 26th, 2020 so they can continue to be sold until May 26th, 2025.
Hi Monir! Good video, thanks. I have a question that might go a bit off-topic... If a European manufacturer owns a product design, as well as its CE marking, but one day wants to outsource the full manufacturing (including labeling and packaging) to an factory OUTSIDE the EU... Would they have to become an Importer? At first glance I would say yes, but at the same time it's their design, their CE marking, their product, which they have been manufacturing themselves and selling for decades on the EU market. The questions that I have would be... 1) As I mentioned, would they still be considered the Legal Manufacturer in that case or would they need to become an Importer? 2) This is based on question 1, but what company name and address would have to appear on the label of the device? 3) If the EU company does not become and Importer, but instead keeps being a Legal Manufacturer, wouldn't there be any issues at customs when bringing a "finished" device? And thank you for all your videos!
Even if you subcontract manufacturing they can continue to be legal manufacturer. They are the owner of the product and their name will be on the product. The subcontractor that is manufacturing the product can be considered as a critical supplier.
Hi @@EasyMedicalDevice, thank you for the answer! Just to confirm, so then it does not matter that you are subcontracting the FULL process, and that the device enters the EU space already labeled/packaged? The device coming into EU already "finalized" was my main concern. We know that we can subcontract the manufacturing to an extra-EU factory, bring into EU the semi-finished product, and label/package/finalize it here. But we are thinking about also doing all those things in the same extra-EU factory, and we had this doubt.
Supposing that a manufacturer is based outside the EU and produces product X. Product X has never been sold to any EU country. Then company A from France purchases product X from the manufacturer and sells it to a hospital in France. Is company A considered an importer? After a month company B from Spain purchases product X and sells it to a hospital in Spain. Is company B considered as an importer as well? Is the first placing in each country of the EU the parameter that determines if one is an importer or is it the first placing in any of the EU countries that defines the importer?
Hi Christos, company A and Company B are both importers with your example as they are the first one approving the entry of the product X in Europe. We can have multiple importers for Product X. But we can also have only 1 that will then distribute products to other distributors. We can have also an independant importer that never see the product (See episode with Medenvoy). Even if Company A and Company B don't want to be the importers, by law they are. So they will need to follow EU MDR article 13. Some companies are importers of devices without knowing it.
@@EasyMedicalDevice Thank you very much for your prompt reply Monir! What if Company C also from France purchases product X from the manufacturer and sells it to a hospital in France? Company C will not be the first one placing the product on the market of France as Company A has already done it! Would in this case company C be considered as an importer? I am a little confused! Ps i am currently watching the episode with Medenvoy!
If I may offer my thoughts, the concepts may be simplified from legal definitions into layman’s terms; Making Available = selling a device Putting into service = use of a device Those are more simple and easy terms for most people to digest. Do you agree?
Do you have a case where the concept of placing on the market is key for your EU Medical Device Industry Strategy? For example for Class I products that need to be placed on the market before May 26th, 2020 so they can continue to be sold until May 26th, 2025.
Hi Monir! Good video, thanks. I have a question that might go a bit off-topic...
If a European manufacturer owns a product design, as well as its CE marking, but one day wants to outsource the full manufacturing (including labeling and packaging) to an factory OUTSIDE the EU... Would they have to become an Importer?
At first glance I would say yes, but at the same time it's their design, their CE marking, their product, which they have been manufacturing themselves and selling for decades on the EU market.
The questions that I have would be...
1) As I mentioned, would they still be considered the Legal Manufacturer in that case or would they need to become an Importer?
2) This is based on question 1, but what company name and address would have to appear on the label of the device?
3) If the EU company does not become and Importer, but instead keeps being a Legal Manufacturer, wouldn't there be any issues at customs when bringing a "finished" device?
And thank you for all your videos!
Even if you subcontract manufacturing they can continue to be legal manufacturer. They are the owner of the product and their name will be on the product. The subcontractor that is manufacturing the product can be considered as a critical supplier.
Hi @@EasyMedicalDevice, thank you for the answer! Just to confirm, so then it does not matter that you are subcontracting the FULL process, and that the device enters the EU space already labeled/packaged? The device coming into EU already "finalized" was my main concern.
We know that we can subcontract the manufacturing to an extra-EU factory, bring into EU the semi-finished product, and label/package/finalize it here. But we are thinking about also doing all those things in the same extra-EU factory, and we had this doubt.
Supposing that a manufacturer is based outside the EU and produces product X. Product X has never been sold to any EU country. Then company A from France purchases product X from the manufacturer and sells it to a hospital in France. Is company A considered an importer? After a month company B from Spain purchases product X and sells it to a hospital in Spain. Is company B considered as an importer as well? Is the first placing in each country of the EU the parameter that determines if one is an importer or is it the first placing in any of the EU countries that defines the importer?
Hi Christos, company A and Company B are both importers with your example as they are the first one approving the entry of the product X in Europe. We can have multiple importers for Product X. But we can also have only 1 that will then distribute products to other distributors. We can have also an independant importer that never see the product (See episode with Medenvoy). Even if Company A and Company B don't want to be the importers, by law they are. So they will need to follow EU MDR article 13. Some companies are importers of devices without knowing it.
@@EasyMedicalDevice Thank you very much for your prompt reply Monir! What if Company C also from France purchases product X from the manufacturer and sells it to a hospital in France? Company C will not be the first one placing the product on the market of France as Company A has already done it! Would in this case company C be considered as an importer? I am a little confused!
Ps i am currently watching the episode with Medenvoy!
If I may offer my thoughts, the concepts may be simplified from legal definitions into layman’s terms;
Making Available = selling a device
Putting into service = use of a device
Those are more simple and easy terms for most people to digest.
Do you agree?
clp91009 completely, thanks for that. I hope this helps others that are looking for more clarity.
What about "placing on market" in layman's term ?
Selling the device for first time in that country/region ?
The video sound is pretty good, beyond my imagination