No less than 35 medtech organizations have signed an open letter to the European Commission calling for urgent and comprehensive structural reform of the EU’s Medical Device Regulation (MDR) and the IVD Regulation (IVDR).
Entire EU Medtech Industry Throws Weight Behind Argument To Structurally Reform MDR And IVDR
The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?
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US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.