Why IVDs Will Be Urgently Jostling For Notified Body Attention
With the EU's Medical Device Regulation and IVD Regulation having been drafted, adopted and now taking effect at the same time, the EU IVD sector often seems to be lagging behind its bigger medical device brother. Now it must fight to the front of the queue to get help from increasingly pressured notified bodies to survive through the transition process.
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How to get non-CE-marked medical devices onto the UK market at speed
Manufacturers normally must pay to access medtech and personal protective equipment standards. But now some are freely available in the EU.