On behalf of the Life Science Manufacturers Association (LSMA) and Verband der Diagnostica-Industrie (VDGH), we wish to thank you for responding to our request to consult stakeholders with regard to the Commission’s proposed changes to Annex I of EU Implementing Regulation 2021/632 laying down the rules for applying border controls on products of animal origin, as per our letter of 18 November 2025.
Our associations represent industries manufacturing and distributing materials and products used in the context of medical and in-vitro diagnostic devices, medicinal products, as well as reagents for general research and safety testing. Our members are directly impacted by the proposed changes as they would introduce significant burdens for importers of Life Science products, particularly due to unclear guidance and likely divergent interpretations across Member States.
These inconsistencies may result in delays or even cancellations of shipments essential to the sector, potentially affecting patients who rely on safe medicinal products and critical medical devices used for microbiological testing, immunophenotyping, and molecular diagnostics.
