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.
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Most items have been ticked off the commission’s implementing plan now; but among the four items left, there is also a new proposal for an implementing regulation for Annex XVI products.
A new Q&A document clarifies the interface between the EU regulations on clinical trials and in vitro diagnostics to support the coordinated assessment of studies involving the use of diagnostic assays.
The IVD expert panel has reviewed the performance of the 16th IVD that it has been asked to assess. The outcome is generally favorable – but with some reservations, including its use in the EU.