Latest from Ashley Yeo
Renewal of the Swiss-EU Mutual Recognition Agreement for medical devices may still be a year or two away, but momentum towards ratification was maintained in March when Swiss and EU political leaders signed the final outstanding agreements of the Bilaterals III sectoral agreements.
Two lawyers within EU legal chamber Axon Lawyers created a Green Team to cope with the rise in EU Green Deal and related environmental sustainability and compliance needs for medtechs. One of them, Jilles van der Hoek, explains why manufacturers should be getting a jump on future requirements.
AI-enabled tools deliver faster radiology reads, clinical decision-support, personalized treatment insights and continuous patient monitoring, but a new report from Firefinch Software and IMed Consultancy advises device developers how to enter and stay in this rapidly growing market.
Payers' and patients' growing preference for outpatient care is increasing pressure on private providers to continually reassess how they deliver value. Jean-Philippe Grosmaitre and Guillaume Duparc, partners at L.E.K. Consulting, outlined growth opportunities available to private hospitals.
Certain short-term EU market improvement measures are expected to be in place this month, said the European Commission, which has challenged device industry stakeholders for input and advice as the EU’s late-2025 bundle of device regulatory improvements begins to take shape.
IMDRF’s playbook on regulatory reliance was in the spotlight at the Forum’s 29th meeting this week, on the heels of its new midterm regulatory strategy document. 2026 IMDRF chair Singapore used the occasion to announce unprecedented WHO acclaim for the nation’s device regulatory oversight.
