How to import your Medical Devices with an Independent Importer?
With the EU MDR 2017/745 and IVDR 2017/746 the role of Economic Operators is becoming clearer. In the case you are located outside of Europe and you need to import your Medical Devices in the EU, you need to have an Importer.
In this episode we will talk of the importer role and what they need to check before your product is placed on the EU market.
And then we will explain the model of Independent Importer which is an entity that is not touching your products but they are still liable for any product on the Market.
This is what Edgar Kasteel from MedEnvoy will try to explain to us.
Who is Edgar Kasteel?
Edgar is an international business development expert and has many years of experience supporting European, American and Asian manufacturers of medical devices and IVDs in establishing or expanding their business across the globe.
Luctor Medical focuses on market entry from a commercial point of view. MedEnvoy assists manufacturers to meet the Importer obligations related to the upcoming MDR and IVDR.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…
Link
- Edgar Kasteel LinkedIn Profile: https://www.linkedin.com/in/edgar-kasteel-0551b71/
- MedEnvoy website: https://www.medenvoyglobal.com/
- Blue Guide CE marking: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC0726(02)&from=BG
- Economic Operators blog post: https://easymedicaldevice.com/economic-operators/
4 Replies to “How to import your Medical Devices with an Independent Importer?”
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Another great podcast that focused mainly on the verification an importer has to do per Article 13 of the MDR. I understood MedEnvoy sets up contracts with non-EU manufacturers obliging the latter to provide the necessary information to do the importer checks. However it was not clear what is qualifying MedEnvoy as importer based on the activities they perform. It sounded more like MedEnvoy will be doing checks to confirm goods can be placed on the market but will not really place them on the market themselves.
From the explanation of edgar, the fact that medenvoy accepts those products and is listed on it as the importer make them responsible for anything that happens. So the products that arrive to the distributor are then placed on the market.
According to my research, the manufacturer is not obliged to indicate the importer on the label.
What about Article 14?
Thank you!
Reka
It is not specifically a label. It can be a document attached to the product. This is an additional information that should be provided to track the product