CLINICAL EVIDENCE FOR IVDs: THE NEW GOOD CLINICAL PRACTICES

2022-08-04T14:21:10+00:00June 28th, 2022|Categories: Meditrial|Tags: , , , , , , , |

Atty. Alessia Nuciari, director of compliance Meditrial. The in vitro diagnostics industry has undergone a substantial transformation. IVDR Regulation 746/2017, published in May 2017 and applied from May 26, 2022, introduced major changes in the industry. The main [...]

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 [...]

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 [...]

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 [...]

EU: MDCG issued a guidance on standardization for medical devices

2021-04-19T08:47:50+00:00April 19th, 2021|Categories: Europe, MDR|Tags: , , , |

The European Commission Medical Device Coordination Group (MDCG) adopted a new standardization request for harmonized European standards in support of the MDR and IVDR after its initial standardization request was rejected last year. Contact Meditrial for a free consultation regarding your [...]

EU: MDCG releases IVD classification guidance

2020-11-17T10:34:07+00:00November 17th, 2020|Categories: Compliance, Europe, Regulatory|Tags: , , , , , |

The European Commission’s Medical Device Coordination Group (MDCG) released a  guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR). The guide provides industry a clarification on how to accurately classify diagnostics under the [...]

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