Medical devices
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Medical radionuclides and the UK Regulatory Framework
What the latest Regulatory Study means for government and innovators, and the challenge of strengthening the UK’s health system and industrial capability.
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MedTech Europe among critics of Digital Omnibus talks
Coalition argues Council’s changes would increase complexity, costs, and administrative burdens, impeding EU innovation and competitiveness.
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GRIP at PCC Canada 2026: Life sciences gain momentum, compliance evolves
GRIP will partner with Informa Connect’s Pharmaceutical Compliance Congress: Canada to capture how compliance leaders are helping the industry innovate responsibly amid regulatory complexity.
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UK MHRA brings in proposals to speed up healthcare
The changes from the health regulator would give patients faster access to devices and align classifications of in vitro diagnostic (IVD) devices.
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CMS and FDA unveil a fast track for Medicare access to breakthrough devices
Initial reactions to the new regulatory pathway from medtech industry groups ranged from mostly positive to cautious.
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CMS proposes to roll back add‑on payment pathway for breakthrough devices
A proposed rule change would require breakthrough devices to meet the same evidence standards as all other new technologies, reshaping reimbursement incentives starting in 2028.
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What the ECJ’s landmark ruling on defective products liability means for life sciences manufacturers
This article covers the expanded litigation risk, the steps life science companies should take to reinforce their product safety, and risk‑management governance.
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Medical device maker Stryker hit by Iranian-based cyberattack
Incident expected to continue causing disruptions and “limitations of access” to company information systems and business applications.