On 03-FEB-2025 Toetsing Online transferred to Research Portal as the internet portal for registering, submitting and managing medical research in The Netherlands. Make sure to create an account and import your #clinicaltrials regestered in there.
Lees meerMedTech Europe issued an MDR/IVDR statement after EPSCO meeting discussing the MDR and IVDR. Whereas clinical evidence forms the foundation of patient and user safety, clinical is not mentioned anywhere. While supporting this statement in general, the phrase that the EU commission should act swiftly – indeed they should – and implement solutions to “Significantly […]
Lees meerEU commission issues an updated planning for gradual roll out of the EUDAMED modules, however, the timeline for delivery of the clinical investigations / performance studies module has been set yet. In other words we are still stuck with local approaches when it comes to adverse event reporting to the regulatory bodies involved in clinical […]
Lees meer