All Insights
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Life Sciences and Healthcare
Data-driven digital health businesses challenged with balancing AI advances and tighter regulation in 2026
Hyper-personalisation, data interoperability and AI are among 2025's fast-evolving areas to continue to watch this year
Life Sciences and Healthcare
EU MDR and IVDR poised to remain main framework for medical AI in draft AI interface reforms
Lex specialis treatment, integrated notified body reviews and clarified duties are designed to limit overlapping regulation of medical AI
Life Sciences and Healthcare
EU digital by default medtech plans signal shift in submissions, product information and online sales
E-submissions, digital documentation and clarified Eudamed and UDI duties to steer medtech towards fuller digitalisation
Life Sciences and Healthcare
Planned EU medtech changes and codified Helsinki procedure support consistent qualification and classification
EU coordination, expert panel opinions and targeted down classification are proposed to harmonise risk based outcomes
Corporate
Confidence in a changing global market: 2025 dealmaking themes and 2026 market opportunities
The global transactional market demonstrated resilience amid complexity in 2025 as it staged a measured recovery
Life Sciences and Healthcare
What will shape European life sciences and healthcare in 2026?
There will be comprehensive regulatory changes across the UK and EU, with streamlined approval pathways alongside heightened governance and compliance
Life Sciences and Healthcare
EU drug agency to take broader coordinating role in devices and diagnostics in latest proposal
Expert panel support, shortage coordination and combined study procedures strengthen the EMA's oversight of devices
Life Sciences and Healthcare
Revised EU medtech regulations proposal sharpens software and cybersecurity rules for digital health
Down‑classification, established software concepts and cyber-incident reporting could reshape digital medtech compliance
Regulatory Outlook
Products | UK Regulatory Outlook January 2026
General/digital products UK: Product Regulation and Metrology Act consultations and guidance | Government response to the independent review of the
Life Sciences and Healthcare
Proposed EU medtech laws seek more predictable and efficient notified body oversight
Structured dialogue, streamlined sampling, extended audits and SME‑friendly fees to reshape device conformity assessment
Digital Regulation
Simplification for AI Medical Devices?
How the European Commission’s proposal on amending the MDR and IVDR adds to the simplification efforts by the Digital Omnibus
Life Sciences and Healthcare
EU revised device rules rebalance compliance towards simplification and proportionality
Commission proposal would streamline MDR and IVDR duties with flexible evidence, timeless certificates and tailored risk rules
