Auteur: acs

EU Commission issues decision flowchart for devices covered by the MDR transitional period |

EU Commission issues guidance on the summary of the clinical study report |

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52023XC0508(01) No real surprises there for those with experience in medical device clinical trials, but practical as a kind of checklist. Noteworthy are the instructions on the identification number until full functioning of EUDAMED, and the participant flow chart.

CEO presentation on Adverse Events handling under the MDR (2017/745) |

With the change from MDD to MDR Adverse Event (AE) reporting in Medical Device Clinical Trials is supposed to be clearer and more uniform, but is it? There has not been a topic that I have been discussing more than that leaving me to conclude that at this moment the answer is no due for […]

EU Commission adopts decision for safe EU-US data flows |

Adequacy decision for safe EU-US data flows (europa.eu) “On the basis of the new adequacy decision, personal data can flow safely from the EU to US companies participating in the Framework, without having to put in place additional data protection safeguards.”

MDCG updates guidance on significant changes for MDD and AIMDD devices |

https://health.ec.europa.eu/system/files/2023-05/mdcg_2020-3_en.pdf

EU Commission issues guidance on the clinical investigation report  |

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52023XC0508%2801%29

NVFG ClinOps Medical Device meeting |

ACS CEO presented on AE reporting under the MDR.

The ‘extension’ to the MDR enters into force throughout the Union |

Note that the Union includes Turkey, Iceland, Liechtenstein, and Norway. https://medicaldeviceslegal.com/2023/03/20/mdr-and-ivdr-amendment-has-entered-into-force-now/ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&toc=OJ%3AL%3A2023%3A080%3ATOC

MDCG updates overview on guidance documents in development |

Interestingly it lists EUDAMED as N/A. What is the planning for the clinical module on reporting of serious adverse events and device deficiencies and related updates? QA document on performance studies, and template and guidance for safety reporting in performance studies under IVDR is foreseen for Q3 2023. https://health.ec.europa.eu/system/files/2023-03/mdcg_ongoing-guidance.pdf

EMA issues presentation on the pilot for expert panels for high-risk medical devices |

https://www.ema.europa.eu/en/documents/presentation/presentation-information-session-pilot-expert-panels-scientific-advice-manufacturers-certain-high_en.pdf