Categorie: News Ticker

Go Red for Women Day

#Cardiovasculardisease (CVD) in #women remains underdiagnosed and #undertreated due to the #diagnostic challenge it presents, as well as the persisting #attitude that CVD predominantly affects men. Gender-related risk factors have now been identified but there is a lack of clinical application, leading to the misdiagnosis and poor management of women with CVD. It is necessary […]

EU Member States announce the launch of a pilot for coordinated assessment of medical device clinical trials |

EU Member States announce the launch of a pilot for coordinated assessment of clinical investigations and performance studies conform the MDR (2017/745) and IVDR (2017/746). “This pilot will allow sponsors to submit a single application for pilot coordinated assessments” in line with MDR/IVDR’s spirit to simplify things.

Toetsing Online becomes Research Portal

On 03-FEB-2025 Toetsing Online transferred to Research Portal as the internet portal for registering, submitting and managing medical research in The Netherlands. Make sure to create an account and import your #clinicaltrials regestered in there.

The Ripple Effect of Protocol Amendments in Medical Device Clinical Trials

Clinical trial protocols, or Clinical Investigation Plans (CIPs) in the case of medical devices, are foundational documents that define the structure and conduct of a study. As a Director of Clinical Operations in a Clinical Research Organization (CRO), I’ve encountered countless discussions about whether a protocol amendment is truly necessary. Each conversation underscores one reality: […]

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 […]