Categorie: News Ticker

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 […]