December 12, the EU commission called out to stakeholders for evidence regarding possible shortcomings of the MDR and IVDR. Proof regarding costs, the administrative burden, availabilty of devices, and the possible impact on the development of innovative devices are requested, This to support the evaluation of the efficacy of the MDR and IVDR. Consultation is […]
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 meerThe miss rates of corona antigen self-tests as reported in practice are quite shocking compared those reported in the self-test labelling. What causes those misses? What do we know based on data from clinical practice? I looked at 6 reasons (and a bonus reason) that may explain why self-tests miss a diagnosis, and checked the […]
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