What are Custom Made devices under EU MDR? [Erik Vollebregt]

The EU MDR is changing a lot of things for medical devices, and even on Custom-made.
The definition changes and has a huge impact on already marketed products. The manufacturers have to assess their portfolio to define again if their products are custom-made or not.

In this episode, Erik Vollebregt will try to explain to you the rules you'll need to follow.

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► Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing 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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses...

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► Links from the Video

■ Erik Vollebregt Linkedin Profile:   / erikvollebregt  
■ Axon Lawyers: https://www.axonlawyers.com/
■ Erik’s blog: https://medicaldevicelegals.com
■ MDCG 2021-3:https://ec.europa.eu/health/sites/def...

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► Social Media to follow

■ Monir El Azzouzi Linkedin:   / melazzouzi  
■ Twitter:   / elazzouzim  
■ Pinterest:   / easymedicaldevice  
■ Instagram:   / easymedicaldevice  

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#easymedicaldevice #medicaldevice #compliance