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Global Medtech Guidance Tracker: September 2021

Executive Summary

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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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.

FDA Finalizes De Novo Process, Updates Related Guidance Docs

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.

EMA Consults On Proposed Framework For Patient Preference Studies

The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.

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