The EU Ecodesign Directive and UK implementing legislation, the Ecodesign for Energy-Related Products Regulations 2010 (as amended) underpin the legal framework governing energy-consuming products and set minimum mandatory requirements for the energy efficiency of certain products. This legislation seeks to bring all products produced or sold in the EU and UK in line with technical standards for sustainability. It requires manufacturers to reduce the energy consumption of their products by establishing minimum energy efficiency standards. It covers over 40 product groups, including boilers, lightbulbs, and televisions.
The UK Ecodesign for Energy-Related Products and Energy Information Regulations 2021, which came into effect in July 2021, introduces eco-design and energy labelling requirements for certain energy-related products to ensure consistency between Great Britain, Northern Ireland and the EU. The Regulations also aim to lower the environmental impact of energy related products by decreasing their energy-usage and carbon footprint.
The EU Sustainable Products Initiative (the SPI), adopted by the EC on 30 March 2022, includes a proposal for a regulation to expand the scope of the Ecodesign Directive, extending requirements and extending products under the Directive to those other than energy-related products, e.g., electronics, textiles, furniture, steel, cement & chemicals. The SPI aims to make products placed on the EU market more sustainable.
Some electronic medical devices may be required to have a constant power supply (i.e., CPAP machines or otherwise), such that the proposed requirements within this legislation would create safety issues.
Medical devices are neither expressly included, nor excluded, from the scope of the EU Ecodesign Directive or the Ecodesign for Energy-Related Products Regulations 2010. In the absence of any express exclusion provision, life sciences companies may wish to ensure that their products comply with these important pieces of legislation.
In contrast, the Ecodesign for Energy-Related Products and Energy Information Regulations 2021 is clearer in that it expressly excludes medical displays which are, or form part of a medical device within the meaning of regulation 2(1) of the Medical Devices Regulations 2002 (as amended).
The energy efficient design of medical imaging equipment such as x-rays, ultrasounds and MRIs, is expressly called for in a ‘Self-Regulatory Initiative on EcoDesign of Energy using Products for Medical Imaging Equipment’ (SIR) presented in 2008 – and updated in 2012 - by the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR), which represents the Radiological and Healthcare IT industry in Europe. COCIR’s SIR is a growing initiative and seeks to achieve the same objectives as the EU Ecodesign Directive and fulfil certain criteria.
The Inception Impact Assessment published by the EC which sets out the aims and objectives of the EU’s Sustainable Products Initiative does not give any indication as to whether the EU Ecodesign Directive will be extended to expressly apply to medical devices. However, in anticipation that it may be extended to include medical devices, as a matter of caution, life sciences companies may wish to start considering the sustainability of existing product lines and also products that will be placed on the EU market in the future.