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Each week we provide a round-up of key legal developments in the life sciences sector curated by our life sciences legal team. This includes

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Latest Life Sciences News

MHRA announces enhanced US collaboration and new international reliance routes for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced an expanded partnership with the US Food and Drug Administration (FDA) to accelerate innovation in medical technologies and artificial intelligence (AI), improve patient safety, and reduce regulatory barriers between the two countries. At the AdvaMed conference, MHRA Chief Executive, Lawrence Tallon, outlined plans for deeper regulatory alignment, including the launch of the National Commission on the Regulation of AI in Healthcare, which features UK and US experts and global tech representatives. The Commission will guide safe and transparent AI adoption across the NHS. Additionally, the MHRA confirmed new international reliance routes that will enable faster UK market access for medical devices approved by trusted regulators such as the FDA, with legislative reforms expected in 2026 and implementation from 2027.

EFPIA and CE publish statements calling for data-driven EPR Under UWWTD

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Cosmetics Europe (CE) have published statements expressing concerns over the attribution of toxic load contributions from micropollutants to their respective sectors under the proposed Extended Producer Responsibility (EPR) scheme, part of the revision of the Urban Wastewater Treatment Directive (UWWTD). While both organisations support the directive’s objectives and the polluter pays principle, they argue that current data significantly overstates their sectors’ contributions to micropollutants. CE highlights a discrepancy in the toxic load attributed to its sector, with the Commission estimating 26% and its own analysis showing just 1.54%. EFPIA similarly questions the accuracy of figures attributed to the pharmaceutical. Both organisations call for a substance-based, sector-neutral EPR model backed by a harmonised EU list of micropollutants to ensure fair attribution and promote eco-design.

Team-NB and ABHI respond to Commission’s call for evidence on MDR and IVDR revision

The European Association of Medical Devices Notified Bodies (Team-NB) and The Association of British HealthTech Industries (ABHI) has submitted its response to the European Commission’s call for evidence on the targeted revision of Regulation(EU) 2017/745 Medical Regulation (MDR) and Regulation (EU) 2017/746) In Vitro Diagnostic Medical Regulation (IVDR).

MedTech Europe responds to European Commission call for evidence on Innovation Act

MedTech Europe has submitted recommendations to the European Commission's call for evidence on the forthcoming European Innovation Act, following a consultation that closed in early October 2025. The trade association calls for explicit recognition of medical technology as a strategic sector and requests streamlined pathways from research to market without substituting urgently needed sectoral reforms, including planned Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation (IVDR)) reforms scheduled for late 2025. Key recommendations include establishing formal coordination mechanisms between EU Directorates-General, implementing innovation-friendly public procurement using Most Economically Advantageous Tender (MEAT) criteria as the default above EU thresholds, and creating regulatory sandboxes for medical technology breakthrough innovations. MedTech Europe also proposes establishing a health innovation coordination platform bringing together member states, EU institutions, regulators, and industry stakeholders to reduce Single Market fragmentation. The submission emphasises closing scale-up finance gaps and supporting late-stage validation and first adoption in health systems, while calling for the Act to complement rather than replace dedicated sectoral legislative reforms.

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