Categorie: News Ticker

EU Commission calls for evidence on possible shortcomings of the MDR |

December 12, the EU commission called out to stakeholders for evidence regarding possible shortcomings of the MDR and IVDR. Proof regarding costs, the administrative burden, availabilty of devices, and the possible impact on the development of innovative devices are requested, This to support the evaluation of the efficacy of the MDR and IVDR. Consultation is […]

MedTech EU issues MDR/IVDR reform statement after EPSCO |

MedTech Europe issued an MDR/IVDR statement after EPSCO meeting discussing the MDR and IVDR. Whereas clinical evidence forms the foundation of patient and user safety, clinical is not mentioned anywhere. While supporting this statement in general, the phrase that the EU commission should act swiftly – indeed they should – and implement solutions to “Significantly […]

MDCG issues guidance on the publication of medical device clinical trial reports in absence of EUDAMED |

In absence of EUDAMED the EU issued guidance with respect to the publication of medical device interventional study reports and summaries of Article 62 and 74.1 studies. Noteworthy is that it is key to have one single ID, i.e. CIV-ID, and that the Competent Authority that generated it “will transmit to the Commission the two […]

NEW DECLARATION OF HELSINKI – HOW BIG IS THE IMPACT? |

EU Commission updates guidance on borderline medical device and medicinal products |

EU Commission updates guidance on borderline medical device and medicinal products under MDR: https://health.ec.europa.eu/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf

ISO on the Clinical Evaluation of Medical Devices in progress |

Happy that an ISO standaard for the clinical evaluation of medical devices is progressing. Especially given there is no MDCG guidance available yet apart from the ones for orphan medical devices, equivalence, medical device software, and sufficient evidence for legacy devices. So we are still stuck with MEDDEV 2.7.1 and the IMDRF MDCE WG/N56 for […]

EU PARLIAMENT ADOPTS MOTION TO REVISE MDR |

On 23 October the EU Parliament adopted parts of the joint motion for a resolution calling on the EU Commission to urgently revise the MDR and IVDR, stressing for example “the need to eliminate the unneccesary re-certification of products. and underlines that certain product updates or adjustments should not necessarily lead to an entire re-certification […]

WMA issues new version of the Declaration of Helsinki |

October 2024 WMA issued a new version of the Declaration of Helsinki. Most striking changes include:

State of play MDR & IVDR implementation |

July 4th the EU Commission organised an information session on MDR/IVDR for international regulators. In case you missed it, please herewith find the presentation: https://health.ec.europa.eu/document/download/93e2d43c-9da8-40b1-b6d8-8f36962c92f9_en?filename=ev_20240704_presentation.pdf

CCMO submission portal changes February 2025 |

https://www.toetsingonline.nl/to/ccmo_web.nsf/CCMO.xsp?page=home New submissions to be done via the new Research Portal. Submissions in review will still be processed through the current system.