Description: The EU is in the process of overhauling its horizontal environmental legislation and adopting new environmental legislation as part of the EU’s Green Deal program. 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.
Most of these updated and new regulations have in common that they do not exclude medical devices and IVDs from their scope, and therefore apply to them in full. Manufacturers of medical devices and IVDs to be placed on the market should be aware of how these regulations affect design, intended use and marketing claims, and as of when the respective requirements apply. This session will provide a ‘tour de horizon’ of current and near future legislative initiatives and how these will affect manufacturers of medical devices 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
