The new Regulation (EU) 2023/1542 on batteries and waste batteries introduces significant changes and new requirements aimed at supporting the sustainability and safety of batteries and battery-operated products.
If you are a manufacturer, importer, distributor, waste management operator/recycler, or operator involved in repair, maintenance, or repurposing operations, and your medical device or IVD uses or incorporates any of the following types of batteries
📍 portable batteries
📍starting, lighting, and ignition batteries
📍light means of transport batteries
📍electric vehicle batteries; and
📍industrial batteries
you will need to conduct a gap assessment and implement the new requirements.
Remember
⚠️By August 18, 2024, portable batteries must comply with the EU Battery Regulation 2023/1542, i.e., they must have in place compliant technical documentation, declaration of conformity, and CE marking.
Contact Evnia if you need help!
