EU Batteries Regulation 2023/1542: Essential Compliance Guide for Batteries in Medical Devices

The EU Batteries Regulation that took effect in February 2024 introduces sweeping changes to how batteries must be designed, manufactured, and integrated into medical devices. 

This isn't just another compliance hurdle—it's a fundamental shift that could impact your product design, supply chain, and market access. 

What's at Stake? 

• Product Redesigns: Battery removability requirements by 2027
• Expanded Obligations: New due diligence and producer responsibility rules
• Market Access: Non-compliance could trigger withdrawal from EU markets
• Hidden Costs: Potential for unplanned re-certification under MDR/IVDR 

Our Comprehensive E-Book Covers: 

• Which medical devices are affected and which are exempt 
• Key deadlines you need to prepare for now 
• Practical steps to ensure compliance 
• How to turn these challenges into competitive advantages 
• Strategic approaches to minimize disruption and cost 

Expert Insights From Industry Veterans 

Authored by Dr. Rossella Fontana (Quality and Regulatory Affairs Manager), this guide leverages decades of experience in medical device compliance and safety certification. 

Don't Wait Until It's Too Late 

The time to prepare is now. Access our e-book below to understand your obligations and contact Veranex to develop a strategic compliance roadmap.