The landscape of medical device manufacturing is evolving, and a significant change is on the horizon. The new EU Batteries Regulation, which came into effect on August 17, 2023, is set to reshape the industry’s approach to battery production and usage. This blog aims to highlight the key points and upcoming deadlines that medical device and In Vitro Diagnostic (IVD) manufacturers need to be aware of.
Who Does This Affect?
This regulation impacts:
- Manufacturers developing and producing batteries
- Companies using batteries specifically designed for their devices by OEMs
- Importers bringing devices with batteries from non-EU countries
Key Changes and Deadlines
- Conformity Assessment and Declaration: By August 18, 2024, manufacturers must:
- Complete appropriate conformity assessment procedures
- Issue a Declaration of Conformity (DoC) for their batteries
- Substance Restrictions: Also from August 18, 2024, new limitations on lead usage in batteries will be enforced.
- Marking and Labeling: From August 18, 2025, all batteries must display the ‘separate collection’ symbol (commonly known as the “wheely bin” icon).
Special Considerations for Medical Devices
While the regulation is comprehensive, it does offer limited exceptions for medical devices and IVDs, particularly regarding battery removability and replaceability.
Importer Responsibilities
Companies importing devices with batteries from outside the EU have additional obligations, including:
- Verifying compliance with substance restrictions
- Ensuring performance and durability standards are met
- Checking proper labeling and marking
- Confirming that appropriate conformity assessments have been conducted
- Ensuring availability of DoC and technical documentation
- Verifying correct CE marking and labeling
Why This Matters
The phased implementation of these regulations means that manufacturers and importers need to stay vigilant and proactive. Failing to adapt to these changes could lead to significant disruptions in production, sales, and distribution.
Next Steps for Manufacturers
- Review your current battery technologies and sourcing
- Plan for conformity assessments well ahead of the August 2024 deadline
- Begin updating labeling and marking processes for the 2025 requirements
- For importers, establish robust verification processes for incoming products
Conclusion
The new EU Batteries Regulation represents a significant shift in how the medical device industry approaches battery technology. By staying informed and preparing early, manufacturers can ensure a smooth transition and maintain compliance in this changing regulatory landscape. Remember, these changes are phased, so it’s crucial to keep track of upcoming deadlines and requirements to avoid any potential setbacks.
Stay tuned for more updates as we continue to navigate these new regulations together!