Medical devices

MedTech Europe and EFPIA respond to Commission's State of the Union speech

MedTech Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have responded to the European Commission President’s State of the Union Address with differing levels of detail and emphasis. While EFPIA broadly welcomed the Commission’s initiatives, particularly the announcement of a Life Sciences Strategy and efforts to address long-standing barriers to competitiveness, MedTech provided a more substantive and targeted response.

Life Sciences weekly highlights—11 September 2025

This week's edition of Life Sciences weekly highlights includes news that MedTech Europe published a position paper supporting proposed revisions to the Corporate Sustainability Due Diligence Directive and the Corporate Sustainability Reporting Directive and recommended further revision; a British pharmaceutical industry (ABPI) blog post criticises the Voluntary Scheme for branded Medicines Pricing, Access and Growth (VPAG) levy increases as driving disinvestment, with companies withdrawing UK investments, cutting headcounts and retreating from NHS partnerships; the European Commission published Q&A guidance on the implementation of the Health Technology Assessment Regulation (EU) 2021/2282; and the European Commission launched a consultation on proposed reforms aimed at simplifying the EU medical devices legislation (MDR/IVDR). Also included, is news that the Commission published a Staff Working Document presenting amendments to the Critical Medicines Act, the MedTech and European pharma (EFPIA) industries responded to the EU's State of the Union Address generally favourably but with further specific recommendations from MedTech Europe and the Proprietary Association of Great Britain (PAGB) has rejected a formal advertising complaint and subsequent appeal by Kenvue regarding Allevia’s ‘It’s a No-Brainer’ claim; among other stories.

ASA Rulings—10 September 2025

Two complaints were upheld by the Advertising Standards Authority (ASA) in relation to alcohol advertising, as part of a wider piece of work on alcohol advertising. The rulings follow investigations triggered by the ASA’s Active Ad Monitoring system, which uses AI to identify potentially non-compliant online ads.

Commission launches call for evidence on medical devices regulation reform

The European Commission has launched a call for evidence to gather feedback on proposed reforms aimed at simplifying EU rules governing medical devices and in vitro diagnostics. This initiative seeks to ensure the continued availability of safe and innovative devices while upholding high standards of patient safety and public health. Based on an evaluation of the current regulatory framework, the proposal intends to enhance competitiveness in both the internal market and on a global scale, support innovation, and reduce dependency on external suppliers. Additionally, it aims to render safety requirements more proportionate and cost-efficient. Stakeholders are invited to submit their responses by 6 October 2025.