Just as concerns are growing in the sector about how notified bodies will manage simultaneous surges in requests for recertification and legacy devices around 2027/28, the European Parliament has launched a key initiative.
The European Parliament is asking the European Commission to make significant changes to the recertification of medical devices under the Medical Device Regulation.
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The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
The deadline for comments is 30 June 2025
Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.
Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.
The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.
The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.
Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.
