Spoiler: at the moment basically nothing except more paperwork and trade barriers. It’s still a hard Brexit with a little sugar on top, essentially. Or, if you are a more glass half full kind of person: at least not all the way back to WTO rules but a just one step above that. After a […]
Wasn’t the MDR about More Data Required, and the same for the IVDR? Aren’t more and more devices running software that processes patient and user data? Isn’t the medical devices industry a very international business? Indeed – so the ability for companies working with the MDR and IVDR to transfer personal data internationally for all […]
Clients often ask me why they should invest in General Data Protection Regulation (GDPR) compliance so much. For medical devices and medicines regulatory compliance, they get it to an extent. Non-compliant devices carry risk of enforcement, which can lead to them being taken off the market. Devices off the market = collapse of cash flow […]