All Insights
Showing 1 - 12 of 360
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
Intellectual property
Looking forward: what is on the agenda for European patent litigation in 2026?
European courts' long-arm jurisdiction and escalating comity tensions in SEP licensing disputes will be at the forefront, alongside sweeping EU
Life Sciences and Healthcare
Standardisation for Clinical Trial Agreements: Germany’s New Standard Contractual Clauses
To bolster Germany’s attractiveness as a location for medical research, the Federal Government published standard contractual clauses (“SCC”) for clinical
Life Sciences and Healthcare
European Parliament and Council provisional deal on new genomic techniques brings relaxation of gene editing a step closer
Two-tier categorisation of NGT plants endorsed alongside a patent ban rowback but patent transparency measures agreed
Life Sciences and Healthcare
EU's new bioeconomy strategy intends to harness sustainable innovation in life sciences and healthcare
Strategy aims to take advantage of 'biotechnology revolution', boost innovation and deliver sustainable solutions – what does this mean for
Life Sciences and Healthcare
The US BIOSECURE Act: is your supply chain at risk?
The legislation could be enacted by the end of the year, with potentially wide-ranging consequences for biotech companies undertaking federal
Life Sciences and Healthcare
EU triggers mandatory Eudamed use for diagnostics and medtech from May 2026
First modules declared functional under phased approach, with vigilance and clinical studies still to follow
Life Sciences and Healthcare
Medical devices, diagnostics and pharma win concessions in EU Digital Omnibus proposal
Commission acknowledges implementation challenges, adjusts high-risk AI requirements for the life sciences sector
Life Sciences and Healthcare
Autumn Budget 2025: what does recent government policy mean for UK life sciences and healthcare?
Targeted R&D support and faster regulatory pathways will be boosted by landmark UK-US pharmaceuticals deal
