New combination products are being developed to fulfil unmet medical needs but the regulations are taking time to catch up. Shayestey Fürst-Ladani and Lindsay Kostadinov report from a conference where drug and device stakholders discussed the problems they are facing. read more
Sometimes you come across cases that violate Mandalorian Creed: “One does not speak unless one knows.”. This happened to me last week when I read the Dutch Supreme Court’s judgment in a…
Or in other words that I’ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should. It still happens to…
Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today, number L080. As you are reading this,…