Placing a devicec in the EU, UK and Switzerland can start to be complicated with what is happening in the region with Brexit, Swixit and the issuance of new legislations. Let’s look at that.
There are many categories of Medical Devices but this one is really special. You can market it very quickly without to wait for a lot of studies and more importantly, it’s a unique product only made for 1 person and this is the Custom-Made Medical Device.
This is a good question. Should we first focus on documents creation or should we focus on our prototypes. This is something that we discuss on this article.
If you have a Drug-Device combination product, it is important for you to read this article which contains all the details about the changes due to the new Medical Device Regulation EU MDR 2017/745