Auteur: acs

Draft version of new ISO 14155 published for voting |

https://www.iso.org/standard/83968.html A new version of ISO14155 is currently under development, and on 20-JUN-2024 ISO/DIS 14155, replacing ISO14155:2020 when ready, entered the voting phase that terminates on 12-SEP-2024. A couple of interesting elements are in (potentially) impacting riskmanagement and safety for medical device clinical investigations (note the scope seems to have widened no longer excluding IVDs), […]

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MDCG issues guidance on clinical evaluations for orphan devices |

https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf By nature ‘orphan devices’ are intended for use in a small number of individuals. This leads to specific challenges for manufacturers and notified bodies on the clinical evidence requirements for the purposes of MDR certification. This MDCG guideline presents guidance on circumstances where it is acceptable to place an orphan device on the market […]

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MDCG issues guidance on the investigator’s brochure |

Referencing Annex B of ISO14155:2020, MDCG issues guidance on the investigator’s brochure: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf

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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

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New version of ISO14155 enters enquiry phase with ISO members |

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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.

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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/

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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

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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.

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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 […]

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