Medical Devices Regulation implementation: crisis averted?

Medical Devices Regulation implementation: crisis averted?

Chris Whitehouse, an expert on medical technology policy at Whitehouse Communications updates readers on changes to the timelines for implementation of the EU’s Medical Devices Regulation and highlights the need to engage with European institutions. A crisis was brewing about European medical device regulation, but it appears that prompt action can still prevent it, allowing makers to exhale in relief. The long-awaited implementation of the EU's new Medical Devices Regulation, originally passed in 2017 but not yet completely implemented, is no exception to the rule that the EU has never been known for making rapid decisions. When compared to a global epidemic that the EU has never experienced before and that wasn't expected when the regulation's specifics were agreed upon, the question is whether its restrictions are still appropriate.




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