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Standards Development
This document defines product category rules (PCR) for conducting life cycle assessments (LCA) and environmental product declarations (EPD) for medical and surgical equipment and orthopaedic appliances corresponding to UN CPC Code 481. These overarching PCR might be complemented by subordinated PCR or product-specific rules (PSR) for a particular product sub-group or dedicated products. Therefore, it also provides guidance on how to develop complementary PCR and PSR in corresponding technical committees.
Additional to the fundamental LCA standards ISO 14040, ISO14044 and the impact specific standards for carbon footprint ISO14067 and water footprint ISO14046 this standard was created to facilitate the understanding and reliable calculation of LCA, avoid misunderstandings, and close existing gaps specifically for the medical device sector. Rules to conduct LCA that are reproducible, consistent, robust, verifiable and most importantly comparable are defined in this standard.
This standard has been developed to:
• support the measurement or estimation of potential environmental impacts of medical devices across their entire life cycle.
• provide transparency on the environmental impacts of the entire life cycle of medical devices to ensure stakeholder expectations are met (e. g. healthcare providers or buyers); and
• provide consistency among studies performed by different practitioners, leading to an overall improvement across the medical industries in regard to their product environmental reporting. This way the understanding of LCA and its results shall be strengthened and comparable communication supported
The purpose of this proposal is to establish harmonized, reliable and practically applicable product category rules for life cycle assessments of medical devices. The need for such a deliverable is driven by a rapidly increasing number of customer requests, emerging regulatory and reporting requirements, (for instance scope 3 data requirements for purchased goods and services as part of CSRD), and growing market expectations for product-level environmental footprint information.
Existing standards and guidance documents already provide important methodological foundations for life cycle assessment and product carbon footprinting. However, they do not fully resolve all sector-specific questions for medical devices, and available guidance documents do not have the same weight, recognition and stability as a European Standard.
Remaining definition gaps, for example regarding functional or declared units, system boundaries, allocation rules, data quality requirements and reporting formats suitable for mass data provision, lead to limited comparability, uncertainty among manufacturers and customers, and inconsistent results.
This lack of comparability is a major barrier to progress. Customers may be confused or misled when product footprints are calculated on different bases, for example when functional units or system boundaries differ. At the same time, suppliers and manufacturers are often reluctant to share footprint data because they fear commercial disadvantages if results are interpreted without a consistent and transparent framework. As a consequence, product-level footprint data is not shared at the speed and scale required for credible purchasing decisions, sustainability reporting and sector-wide decarbonization activities.
A European Standard would address these barriers by providing a recognized, consensus-based and sector-specific reference for the calculation, documentation and communication of life cycle assessment results for medical devices. It would increase confidence in product footprint information, support consistent supplier and customer exchanges, and enable mass calculation approaches required for Scope 3 reporting and sustainable procurement. By improving comparability and reducing methodological uncertainty, the deliverable would also support faster and more credible decarbonization efforts in the product sector. The standard provides a general, uniform framework for all medical devices, but does not preclude the creation of subordinate (specific PCRs) for certain groups of medical devices.
The proposed activity therefore aims to develop a European Standard as a first step, with the potential for later international applicability. Such a standard would provide the necessary authority to move from individual guidance-based approaches towards a broadly accepted framework for comparable product footprints in the medical device sector. As several (European) countries already are developing or are planning country-specific frameworks, rapid harmonization at European level is therefore essential to enable efficient action, avoid market fragmentation, and strengthen Europe as a competitive manufacturing base for medical devices (particularly in cost-sensitive high-volume product segments).
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