New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.
With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs.
With demand for EU notified body medtech services fast outstripping capacity, three well-known notified body experts explain how they are battling to make the new regulatory system work.
Latest figures published by the European Commission show some progress can be expected soon when it comes to notified body designations under the Medical Device Regulation, but very little under the IVD Regulation.
The European Commission’s MDCG has issued revised guidance and advice on safety and clinical performance data required for implantable and class III devices under the MDR.
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