The EC have issued a FAQ regarding the EU ESPR (ECO Design and Sustainable Products Regulation) which includes MD/IVDs in scope. This replaces the traditional legislation that focused on consumer white goods, and the energy usage and water consumption figures etc. Beyond the fact that we could eventually see ECO Design requirements being placed on the sector for products, the other major concern is the broad range of horizontal materials used in products that also fall within the scope of the legislation (Metals, plastics, Glass, Detergents etc.) and the potential impact that minimum recycled content etc. in these materials could have on our sector. This aspect is not covered by the Question 10 response outlined below.
MedTech Europe communication:
Dear members,
We hope this email find you well.
We would like to inform you that the European Commission has published a comprehensive guidance document on the new EU Sustainable Products Regulation (ESPR):
Please find a copy attached:
We draw your attention to the following entry regarding medical devices (page 12);
“10. Do medical devices also need to comply with the ESPR and the DPP?
Medical devices fall within the scope of the ESPR. Should the Commission decide to include medical devices in the first (or any subsequent) ESPR working plan to develop ecodesign requirements, it will take into account the need to not negatively affect the health and safety of patients and users when developing ecodesign requirements.”
