EU Offers Insight On New MDR Guidance Documents On The Horizon

The EU Medical Device Regulation has been in force for a year and the IVD Regulation applied a few weeks ago. Many vital guidance documents have been in the pipeline for considerable time but will be made available later this year.

Computer key - 3rd quarter - Image — The third and fourth quarters of 2022 are going to see a flood of new guidance documents under the MDR and IVDR

The European Commission has issued an update on Ongoing Guidance Development and Deliverables by the various sub-groups of its Medical Device Coordination Group (MDCG), demonstrating when key guidances are due to be published in the next six months.

The update comes as frustration is growing among the medtech industry as some competent authorities and notified bodies are treating...

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