Sustainability for the medical device industry – Concepts, global frameworks and EU regulatory requirements

English

While medical technology companies have not yet been significantly impacted by environmental and other generic sustainability issues, upcoming regulatory changes, especially in the European Union (EU) will change this. This article aims to define sustainability and environmental, social and governance (ESG) concepts, review related international frameworks and focus on the EU regulatory instruments that will affect medical technology companies. Two approaches have been used to analyse the requirements: a ‘plan-do-check-act’ approach that refers to a company’s lifecycle stages, from strategy development to reporting; and a critical environmental sustainability issue perspective, focusing on relevant issues such as single use, waste/packaging, energy consumption and supply chain environmental performance. This analysis by Alain Renard and Robert Speer shows the very complex challenge of managing all regulatory requirements in an integrated way, with Medical Device Regulation requirements being considered together with existing and upcoming sustainability-related requirements from the proposed Ecodesign Regulation and adopted Corporate Sustainability Reporting Directive, for example.

Specification: 15 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the February 2023 issue of the Journal of Medical Device Regulation.