Auteur: acs

ICH assembly adopts Annex 2 of ICH-GCP

Annex 2 provides “additional GCP considerations, focusing on trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD)”. Although ICH-GCP’s focus is on clinical trials with medicinal products, the new guidance specifically the ones on RWD can be relevant for medical devices Post-Market Clinical Followup studies. These considerations include but are not limited to: Ethics […]

MDCG issues new manufacturer incident report |

MDCG issued a new version of the manufacturer incident report. All MIR 7.3.1. versions from the December 2025 publication on are still accepted. The versions published prior to December 2025 can no longer be used. https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en

EMA announces launch of pilot for breakthrough medical devices |

In the second quarter of 2026, the EMA plans to launch a pilot for breakthrough #medicaldevices and #invitrodiagnostics with the goal to test a pathway that accelerates patient access to highly innovative technologies, while guarding #safety and #performance standards. This pilot further builds on the recently adopted guidance MDCG 2025-9: For all devices, clinical evidence must […]

The new version of ISO14155 arrived! |

23rd of March 2026 ISO published the new version of ISO 14155. Changes include In other words all involved in medical device clinical trials regardless whether pre-market or post-market, interventional or observational should take note of it. https://www.iso.org/standard/83968.html

Go Red for Women Day |

#Cardiovasculardisease (CVD) in #women remains underdiagnosed and #undertreated due to the #diagnostic challenge it presents, as well as the persisting #attitude that CVD predominantly affects men. Gender-related risk factors have now been identified but there is a lack of clinical application, leading to the misdiagnosis and poor management of women with CVD. It is necessary […]

EU Directorate for Health and Food Safety issues a proposal for a regulation to simplify rules on medical devices |

December 16 the General Directorate for Health and Food Safety issued a proposal for a regulation to simplify rules on medical and in vitro diagnostic devices. With some very interesting elements in there, the proposal for example includes a suggestion for a wider range of data that may qualify as clinical data with, under Article […]

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 […]