MedTech Forum 2022: How Regulatory Complexity Is Crushing The EU

Is it time to reflect on how the EU can take measures to escape a situation where regulation threatens innovation, product availability and product costs and to stop this trajectory of ever increasing the regulatory bar?

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Much of the discussion related to the EU regulation of medtech products at this year’s MedTech Forum focused on the sheer complexity of the current rules, as well as the manner in which increasing layers of new overlapping and complicated demands are compounding the challenges and creating an overly complicated environment for medtech products.

In a mind-boggling revelation at the meeting, organized by MedTech Europe, BSI Group’s Graeme Tunbridge said that BSI alone now...

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