The regulation of companion diagnostics will be far stricter under the IVDR than the current IVD Regulation. EU life sciences regulatory lawyer Elisabethann Wright provides an overview and explains how companies should prepare for compliance.
Elisabethann Wright
Manufacturers who currently supply CE-marked IVDs in the EU will face challenging hurdles in the short term as they seek...
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Without change, the implementation of the MDR and IVDR could hit another wall.
Evolution of the MHRA and its offering to medtechs continues, with the hunt for a visionary chief medical and scientific officer and release of outline plans on early access to innovative devices, building on IDAP learnings.
Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."
Healthtechs are reflecting on the resignation of Sam Roberts as chief executive of NICE and how medtech assessment program changes underway at the England and Wales HTA body might be impacted.
Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."
Healthtechs are reflecting on the resignation of Sam Roberts as chief executive of NICE and how medtech assessment program changes underway at the England and Wales HTA body might be impacted.
A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.
