Mediqol

I’ve been catching up on my regulatory reading lately and I’ve come across an article from a device consultant recommending that the European Medicines Agency (EMEA) gets involved in medical device regulatory over-sight (http://tinyurl.com/qghar4). We’ve had a bit of a chat about this internally and we aren’t so sure. Where would it lead? What impact would it have on device approval timelines? What expertise do EMEA have in device approval?

We think the medical device regulatory environment in Europe faces challenges and changes need to be made but we don’t think this is the solution.