The seminar addresses current and future legal and regulatory developments relevant to the health related wearables industry, especially medical devices regulation and protection of personal data. It will address market access requirements and give practical how-to guidance on how to design and CE mark a compliant wearable and related software. Click here for Invitation and Programme
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,…