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EU Medtech Regulatory Overhaul Calls For Major Business Strategy Rethink

The EU’s medical device regulatory structure, first devised over 20 years ago, is starting to change. The first major revision of directives will produce a tougher environment and require medtech manufacturers to make some significant adjustments.

The EU’s medical device directives have long been perceived by US manufacturers as less prescriptive and less onerous than the US regulatory system, especially when it comes to high-risk medical devices. Historically, it has been quicker and less expensive to produce clinical data in the EU, and this has encouraged many to use Europe as their launchpad for new devices.

But with the existing EU medical device directives being replaced by tougher medical device regulations in the next few years, the EU may no longer be

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