BVMed and SNITEM: Overcoming the MDR implementation bottleneck

2022-08-26T08:10:00+00:00March 24th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , , , , , |

BVMed and SNITEM: Overcoming the MDR implementation bottleneck The BVMed - German Medical Technology Association and SNITEM - the French National union of the medical technology industry are launching a Franco-German initiative for Medical Device Regulation. In a [...]

Handover of Expert Panels to EMA

2022-08-26T08:11:55+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: , , , , , , , , , , |

Handover of expert panels on medical devices and in vitro diagnostics to EMA Now, the European Medicines Agency has control of the Expert Panels on medical devices and in vitro diagnostic medical devices. On 1 March, the coordination [...]

EUDAMED ACTOR MODULE FAQs – update

2022-10-06T09:26:30+00:00January 3rd, 2022|Categories: Compliance, Regulatory|Tags: , , , |

EUDAMED ACTOR MODULE FAQs - update The European Commission has updated the Eudamed Actor Module FAQs. The document includes a revision of paragraph 4.6.4 relating to the publicly accessible contact details of Person Responsible for Regulatory Compliance (PRRC). [...]

MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation

2022-10-06T09:26:41+00:00December 1st, 2021|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: , , , , , , |

Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2) New guideline for Europe on trial changes has been published! MDCG 2021-28 - Substantial modification of clinical investigation under Medical Device Regulation. The sponsor of [...]

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