How to Ensure the Safety of Mobility Devices with Lithium Batteries: MHRA Recommendations
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
Lithium batteries are a critical technology for powering mobility devices such as electric wheelchairs and mobility scooters. However, if not managed properly, they can pose significant risks, including fire hazards that endanger users’ safety.
To address these concerns, the MHRA (Medicines and Healthcare products Regulatory Agency) has issued important guidance for manufacturers of electric mobility devices. Learn how to ensure regulatory compliance and improve the safety of your products.
Why Lithium Battery Safety Matters
Lithium batteries can overheat, short circuit, and, in some cases, cause dangerous fires. According to the MHRA, proactive measures are essential to prevent such incidents and protect users.
Check if Your Device Complies
Here are the key requirements highlighted by the MHRA:
1️⃣ UK MDR 2002: Ensure your device complies with UK regulations safeguarding safety and performance.
2️⃣ BS ISO 7176-31:2023: This new standard supports testing and verifying the safety of lithium battery systems and chargers.
MHRA Recommendations for Improved Safety
– Clear labeling and warnings: Manufacturers are advised to add warnings about fire risks and the use of unauthorized chargers directly on battery and charger labels. These warnings not only improve device safety but also raise user awareness, potentially saving lives.
– BHTA Guidance: Consult the British Healthcare Trades Association’s lithium battery safety guide to ensure your technical documentation is complete.
– OPSS Guidelines: Follow the Office of Product Safety and Standards’ recommendations for managing battery safety in e-bikes and scooters.
Why Acting Now Is Crucial
Following these recommendations ensures regulatory compliance and demonstrates your commitment to user safety. By adopting standards like BS ISO 7176-31:2023, you can strengthen customer trust and prevent risks associated with lithium batteries.
Frequently Asked Questions (FAQs)
1. Why is lithium battery safety important for mobility devices?
Lithium batteries power many mobility devices, such as electric wheelchairs and scooters. If not managed properly, they can overheat or cause fires, posing significant risks to users’ safety. Ensuring proper safety measures is critical to prevent such incidents.
2. What are the key regulations for mobility devices with lithium batteries?
The key regulations include UK MDR 2002, which ensures the device meets safety and performance standards, and BS ISO 7176-31:2023, which focuses on testing and verifying the safety of lithium battery systems and chargers.
3. What are the MHRA’s recommendations for manufacturers of mobility devices?
The MHRA recommends clear labeling and warnings about fire risks, using only authorized chargers, and consulting the British Healthcare Trades Association’s lithium battery safety guide. They also advise following guidelines from the Office of Product Safety and Standards (OPSS) for battery safety in e-bikes and scooters.
4. How can I ensure my device complies with MHRA guidelines?
To ensure compliance, manufacturers should follow UK MDR 2002 regulations, adopt safety standards such as BS ISO 7176-31:2023, and ensure that their technical documentation is complete as per BHTA guidance. Additionally, use clear labeling to warn users about potential risks.
5. What is BS ISO 7176-31:2023 and why is it important?
BS ISO 7176-31:2023 is a new standard that provides guidance on testing and verifying the safety of lithium battery systems and chargers used in mobility devices. It ensures that products meet required safety performance to minimize risks associated with battery-related hazards.
6. How can following these recommendations benefit my business?
By adopting the MHRA’s safety recommendations, you can ensure regulatory compliance, enhance customer trust, and prevent potential risks associated with lithium batteries. This proactive approach not only improves safety but also strengthens your market reputation.
7. How can I get assistance with compliance and safety standards?
If you need help ensuring your mobility devices comply with safety standards, feel free to contact us or follow our blog for updates. We offer guidance and support to help you meet regulatory requirements and enhance product safety.
Need help ensuring your devices comply with safety standards? Contact us or follow our blog for updates!
