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

2023-03-31T09:46:24+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 [...]

EU: MDCG releases IVD classification guidance

2023-03-31T16:17:03+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

2024-02-23T16:35:16+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 [...]

Go to Top