Auteur: acs

MDCG issues guidance on safety reporting in performance studies under IVDR |

https://health.ec.europa.eu/latest-updates/mdcg-2024-4-safety-reporting-performance-studies-vitro-diagnostic-medical-devices-under-regulation-2024-04-15_en

New version of ISO14155 enters enquiry phase with ISO members |

MDCG issues guidance on content and synopsis of the Clinical Investigation Plan for Medical Device studies |

The MDCG issued guidance regarding the content and the synopsis of the Clinical Investigation Plan (CIP) for Medical Device studies.   A quick review learns there are no big surprise here: to name a few.

EU Council endorses key updates to the IVDR |

https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/

EU Commission proposes IVDR deadline extension |

https://health.ec.europa.eu/latest-updates/commission-proposes-extend-transition-periods-certain-ivds-gradual-roll-out-eudamed-and-information-2024-01-23_en

MDCG issues guidance on exemptions from clinical investigations for class III and implantable devices |

https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-7_en.pdf Among other things it explains that for class III and implantable devices Thereby giving room to device manufacturers to save time and money in their CE-marking process.

MDCG issues guidance on Medical Device Software (MDSW) – Hardware combinations |

The guidance does not intend to address the typical clinical evaluation aspects, for that it refers to MDCG 2020-1, but does emphasize that For option 1 and 2 MDSW* “the MDSW manufacturer must verify, validate and demonstrate the safety, reproducibility, compatibility and interoperability of the medical device or accessory to a medical device that the […]

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 […]