You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]
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 […]
While nothing much comes out at EU level and member states seem to wait until the last moment with implementing legislation (because the people needed for that are caught up in the gridlocked Brussels MDR and IVDR implementation process as a result of structural under-resourcing of medical devices oversight) some member states are really on […]