Global Medtech Guidance Tracker: September 2021
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.
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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.
The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.