Custom-made Medical Devices is really another category of devices. The requirements to put them on the European Union market through the new Medical Device Regulation MDR 2017/745 is really different in comparison to other devices.
On this video, I will provide you all the basic information to understand how to place a custom-made device on the EU market.
I even wrote a blog post where you can find some valuable information and also a template of the document needed to place the product on the market.
Easy Medical Device is your platform to learn about medical devices. I help you with blog posts, videos and also a Podcast so don’t hesitate to come to see what is available.
Links from the Video
Blog Post: https://easymedicaldevice.com/custom-made-device
Is 3D printed device a Custom-made device: https://easymedicaldevice.com/medical-3d-printing/
Social Media to follow
#medtech #medicaldevice #compliance