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 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 [...]

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 [...]

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: The MDCG informs on how to handle class D IVDs during transition to new regulation IVDR

2021-04-12T09:11:45+00:00April 12th, 2021|Categories: Compliance, Europe|Tags: , , , |

The transition period to the new in vitro diagnostic regulation (IVDR) in the EU will last till next 26 May, 2022. In order to inform device manufacturers, the European Commission´s Medical Device Coordination Group issued a Q&A including information on [...]

Switzerland: New requirements and changes to authorization practice as of May 2021

2021-03-24T14:00:30+00:00March 24th, 2021|Categories: Clinical Trial, Europe, MDR, Switzerland|Tags: , , , |

Swissmedic has recently announced new regulations and requirements for the authorization of clinical trials  in Switzerland. Meditrial and its team based in the Zug office manage several studies in Switzerland and has direct connections with Investigators, hospitals  and local Ethics [...]

EU: MDCG issues guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

2021-03-01T10:32:39+00:00March 1st, 2021|Categories: Europe, Regulatory|Tags: , , |

The MDCG issued a new guidance "to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions [...]

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 [...]

EU: Medical Device Single Audit Program guidance by the EU Commission’s Medical Device Coordination Group

2020-08-11T08:36:06+00:00August 11th, 2020|Categories: Compliance, Europe, Regulatory|Tags: , , , , , |

The EU Commission’s Medical Device Coordination Group issued a guidance providing details on how notified bodies can reference Medical Device Single Audit Program  audit reports when planning surveillance audits under the MDR or IVDR. Meditrial can help you to get [...]

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