Categorie: Blog

ACS NEWS OVERVIEW

CLINICAL EVALUATION PLAN – A NEW CLINICAL TRIAL DOCUMENT?

Under MDR Ethics Committees nowadays typically ask for a clinical evaluation plan when submitting for review of a clinical investigation. During the last ACS CRA meeting we discussed that this does not concern a new document but rather an exisiting document which is part of the Product Technical File. Below you find the concerning presentation. […]

ADVERSE EVENT REPORTING UNDER MDR – EASY?

Under MDR Adverse Event reporting is meant to be more straightforward and uniform accross the different EU memberstates, but is that truely the case? One of the topics as discussed during the medical device joined ClinOps and RegNed springmeeting of the NVFG April 2023. Below you find the concerning presentation. Feel free to reach out […]

THE SHOCKING DATA ON CORONA ANTIGEN AND SELF-TESTS IN PRACTICE – PART 3

What causes misses in self tests of 50% or even more? What do we know based on data from clinical practice? In part 1, I showed that the tests can have a miss rate of 1 out of 3 to 1 out of 4 when professionals use it, and even a miss rate of 1 […]

THE SHOCKING DATA ON CORONA ANTIGEN AND SELF-TESTS IN PRACTICE – PART 2

The miss rates of corona 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? In part 1, I showed that the tests can have a miss rate of 1 out of 3 to 1 out […]

THE SHOCKING DATA ON CORONA ANTIGEN AND SELF-TESTS IN PRACTICE – PART 1

The 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 […]

THE MDR IS THERE: BE AWARE OF THE LATEST ISO14155!

With the updated references of harmonised standards for medical devices, ISO 14155: 2020 is THE GCP standard for medical device clinical investigations, and since as of May 26th 2021 the MDR fully applies you may want to familiarize yourself and your team with the changes to ensure proper clinical data collection in line with this […]

COVID-19 CLINICAL EVIDENCE DOWNTIME: HOW TO MAKE USE OF IT!

To date numerous guidances, blogposts, webinars have been published addressing what one must and cannot do in the process of clinical evidence collection due to the COVID-19 pandemic (for overviews see here and here), and with this post I have no intention repeating that, but rather want  to focus on the things we CAN do […]

PREVENTING THE BIG SCARE WHEN YOUR NEXT CLINICAL EVALUATION IS DUE: THE HIDDEN WAKE-UP CALLS FOR LEGACY MEDICAL DEVICES.

How do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR)  applies in May 2021? Can you continue to do what you did under MDD and are you then OK? A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a […]