PRAC Strategy on Measuring Pharmacovigilance Activities

2022-08-24T15:43:37+00:00April 22nd, 2022|Categories: Europe|Tags: , , , , |

Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2) In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and EMA has published a second revision in April 2022. The second revision of the [...]

EMA’s advice on managing the impact of the war in Ukraine

2022-08-24T16:09:53+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: , , , , , , |

EMA’s advice to sponsors on managing the impact of the war in Ukraine on clinical trials EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war [...]

EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A

2022-08-25T10:19:19+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: , , , , , , , |

EMA has published an updated version of its good clinical practice Q&A The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of [...]

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 [...]

Swiss Medical Device Database is Under Construction

2022-08-26T08:11:38+00:00March 4th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: , , , , , |

Swiss Medical Device Database is Under Construction Swissmedic is in the process of developing a new database for registering economic operators and medical devices. Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the [...]

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 [...]

US: FDA guidance on CDRH Appeals Processes

2022-08-26T08:12:13+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , , , , , , |

US: FDA guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to [...]

New MDCG guidance 2022-4

2022-08-26T08:18:34+00:00February 17th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , , , , , |

New MDCG guidance 2022-4 The new MDCG guidance 2022-4 has been published. It clarifies how Notified Bodies shall perform surveillance of legacy devices during the transition period defined in MDR Article 120. The document provides guidance for surveillance [...]

New Guidance: MDCG 2022-3 Verification by Notified Bodies

2022-08-26T08:46:44+00:00February 16th, 2022|Categories: Compliance, Europe, Regulatory|Tags: , , , , , , , , , |

New guidance: MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies In accordance with the conformity assessment procedures (described in Article 48 of IVDR), in addition to quality management system and technical documentation assessments, notified bodies [...]

MDCG updates the IVDR Implementation and Preparation Plan (EU)

2022-09-30T15:22:50+00:00February 7th, 2022|Categories: Compliance, Europe, Regulatory|Tags: , , , , , , , |

The MDCG updates the IVDR Implementation and Preparation Plan (EU) 2017/746 Joint implementation and preparedness plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) has been updated. Meditrial offers strategic-regulatory consulting services. We [...]

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