Medtech Europe, LSMA and VDGH warn of serious impact of proposed changes to EU Implementing Regulation 2021/632

MedTech Europe, together with the Life Science Manufacturers Association (LSMA) and the Verband der Diagnostica-Industrie (VDGH), has submitted a joint letter to the European Commission raising concerns regarding the proposed amendments to Annex I of EU Implementing Regulation 2021/632 on border controls for products of animal origin.

The proposed expansion of the Regulation’s scope has the potential of creating delays, supply shortages, and disruptions that could directly affect patient care, public health services, and food safety.

We therefore call on the European Commission to delay adoption of the proposal and engage in discussions with all relevant stakeholders, including industry. The absence of prior consultation with life science stakeholders has left key practical considerations unaddressed.

Without proper preparation and updated guidance for Member States, imports of critical products – such as cell culture media, analytical reagents, microbiological testing materials, and components for biopharmaceutical manufacturing – may be halted at the border. This could hinder research, disrupt diagnostic services, and exacerbate shortages of medicinal products.

MedTech Europe remain committed to working with the European Commission to ensure that border control measures are effective, proportionate, and aligned with Europe’s ambition to remain a global leader in life sciences.

Read our joint letter below.