All Insights

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
Regulatory Outlook

Products | UK Regulatory Outlook November 2025

General and Digital: European Commission consults on product safety and market surveillance | Council of the EU adopts 'one substance
Life Sciences and Healthcare

Framework to fallout: Care Quality Commission launches single assessment framework review in England

Reforms could revert to a regime that social and health care providers were familiar with prior to changes in 2024
Life Sciences and Healthcare

Implications of the German GEMA ./. OpenAI judgment on the Life Sciences and Healthcare Sector

The District Court of Munich I has issued a landmark ruling on copyright infringement involving AI (11 November 2025, case