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…
- 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/