Categorie: Blog

The Ripple Effect of Protocol Amendments in Medical Device Clinical Trials

Clinical trial protocols, or Clinical Investigation Plans (CIPs) in the case of medical devices, are foundational documents that define the structure and conduct of a study. As a Director of Clinical Operations in a Clinical Research Organization (CRO), I’ve encountered countless discussions about whether a protocol amendment is truly necessary. Each conversation underscores one reality: […]

ACS NEWS OVERVIEW

MDCG issues guidance on the publication of medical device clinical trial reports in absence of EUDAMED |

In absence of EUDAMED the EU issued guidance with respect to the publication of medical device interventional study reports and summaries of Article 62 and 74.1 studies. Noteworthy is that it is key to have one single ID, i.e. CIV-ID, and that the Competent Authority that generated it “will transmit to the Commission the two […]

NEW DECLARATION OF HELSINKI – HOW BIG IS THE IMPACT? |

EU PARLIAMENT ADOPTS MOTION TO REVISE MDR |

On 23 October the EU Parliament adopted parts of the joint motion for a resolution calling on the EU Commission to urgently revise the MDR and IVDR, stressing for example “the need to eliminate the unneccesary re-certification of products. and underlines that certain product updates or adjustments should not necessarily lead to an entire re-certification […]

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 […]