Sponsors of clinical investigations under the EU’s Medical Device Regulation and performance studies under the IVD Regulation have been invited to join a new scheme that should cut study review time and costs to study approval.
Sponsors Can Now Apply For EU’s Time-Saving Clinical Investigations Pilot
The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.
More from Medtech Insight
• By
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.
• By
Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.
• By
After switching production of coatings for its continuous glucose monitors in-house to improve supply, Dexcom ran afoul of US FDA for failing to submit a premarket notification. Firm says launch of 15-day sensor will not be delayed by the problems.
• By
Medtech has not yet been spared from the Trump administration’s trade tariffs, which, for UK exporters will be 10% – half the rate applied to EU27 exporters.
More from Policy & Regulation
• By
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
• By
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.