Against a backdrop of escalating concerns around the environment and sustainability, EcoDesign Regulations (including the EU’s landmark EcoDesign and Green Deal legislation) usher in potential new requirements. Much of this legislation, like the Packaging and Waste Directive, Energy Using Products Directive and the Battery Directive, already exists for some time and is being recasted to update the rules to current policy objectives. Other new horizontal legislation is being adopted, such as against greenwashing and right to repair.
Also considered is the spill-over of US Regulatory requirements (usually single-issue focused e.g. PFAS) and private enforcement by means of product liability . The potential impact on Medical Device manufacturers cannot be understated. These regulations have the potential to disrupt traditional models around innovation, design, manufacture and the overall supply chain. This session will provide a ‘tour de horizon’ of current and near future legislative initiatives and how these will affect manufacturers of MD as well as show insight in other legislative initiatives that may affect the devices industry in the future.
Learning Objectives:
Understanding current and soon to be adopted horizontal EU regulations in the field of environmental protection that affect medical devices and IVDs under the MDR and IVDR.
Learning to distinguish factors relevant to device design and marketing in current and soon to be adopted EU environmental regulation.
Plan for the entry into force of new requirements and draw up transition plans for devices currently CE marked or new on the market
