EUDAMED UDI/devices Updated Technical Documentation Module

2022-08-24T15:47:09+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|Tags: , , , , , , , , |

The EUDAMED UDI/devices module updated technical documentation is available The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device [...]

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 [...]

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 [...]

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 [...]

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2022-10-06T12:45:59+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex [...]

France: ANSM updates guidelines and forms for a scientific opinion for a medical device incorporating a medicinal substance

2022-10-06T14:31:20+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

France: ANSM updates Guidelines and Forms for a Scientific Opinion for a Medical Device incorporating a Medicinal Substance The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical [...]

MDCG outlines rules on EUDAMED registration for custom made and legacy devices

2022-10-06T14:46:01+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

MDCG outlines rules on EUDAMED registration for custom made and legacy devices The European Commission’s Medical Device Coordination Group (MDCG) last week published a new guidance with Q&A on obligations and related rules for the registration in EUDAMED [...]

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