Now this is fun: at a time just before the date of application of the MDR when we do not even have harmonised standards for the new software requirements in Annex I, section 17 MDR and Annex I, section 16 IVDR, the Commission proposes new mandatory regulation to supplement the the MDR and the IVDR […]
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 […]
In several posts on this blog I have discussed the severe impact that the IVDR will have on the IVD industry selling in the EU (just click on IVDR in the tag cloud on the bottom right of the page). My firm has organised multiple seminars and I have spoken about this on more conferences […]
Happy New Year everybody – may your transition to the MDR and IVDR be unproblematic and timely. May your management be convinced that making and selling medical devices is actually core business of the company and dedicate sufficient resources to your transition project. Halfway point of MDR transition 2018 is the year in which we will […]
Change is on its way – medical devices law will not be the same again as of next year. Panic soccer The authorities are not your friend anymore. Notified bodies are engaging in massive ‘panic soccer’ (Dutch expression) dropping companies like they’re hot. If you have not implemented the new clinical evaluation MEDDEV fully by […]
The MDR and IVDR are here now, but the General Data Protection Regulation (GDPR) already beat them to the finish line as it was just adopted. I have written a lot about current and future EU data protection requirements, both on this blog (here, here and here for example) and in other publications. What I […]
Lately I have been doing a lot of work in medical devices M&A projects, some very big, some quite small and some in between. Everybody seems to be merging with everybody else these days as the bigger companies divest branches to reposition and smaller companies put themselves up for sale. These projects are invariably highly […]
Normally one looks back at the end of the year, but I also like to look ahead because there are a lot of developments in EU law that will affect the medical devices industry next year: new rules on cybersecurity, data protection, mHealth and business compliance will put their mark on 2016, additional to the never-ending […]