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After repeatedly putting off substantive efforts to address problems with MDR and IVDR by simply extending deadlines, a real effort to address these issues appears to be underway following the European Commission’s recent proposal to revise the regulations. We lay out the key provisions of that proposal, their potential impact on industry, and how key players view the possibility that these changes might actually happen.
The best private financing deals in February across all clinical categories, and a profile of Israel’s Edge Medical Ventures, which offers portfolio companies a novel commercialization strategy.
A MHRA proposal would allow firms to rely on EU MDR/IVDR CE marks indefinitely in Great Britain. Excerpted from Pathways’ Picks February 18: Britain Gives in to the CE Mark, CMS ACCESS Updates, South Korea Wellness Policy.