EU Classification ‘Bible’ Published To Support Risk Class Decision-Making
The risk class of a medical device depends on its intended purpose and mode of action. But these are not always easy to determine. Now there is EU guidance to support this decision-making.
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Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.
The new EU Medical Device Regulation has introduced stricter clinical evidence requirements for many products. But is it even feasible to generate this data for certain legacy devices, such as those used in spinal fusion surgeries, and which products are likely to fall into the high-risk category?
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.