This document outlines regulations and considerations regarding the removability and replaceability of portable batteries in various devices, with a particular focus on safety and data integrity concerns. Key points include:
- Derogations for Battery Removability:
- Certain devices may have derogations (exceptions) for battery removability due to safety, data integrity, or other operational requirements.
- Safety Considerations:
- Lifesaving, life-sustaining, and safety-critical devices may require a permanent connection between the device and the battery to ensure user safety.
- Data Integrity:
- Devices used primarily for data collection and supply must adhere to strict data integrity considerations to prevent loss or corruption of critical information.
- Software Limitations:
- Software should not hinder the replacement of a portable battery with a compatible one, ensuring ease of maintenance and sustainability.
- Parts-pairing practices that discourage repair or replacement of individual parts, such as batteries, should be avoided.
- Regulatory Framework:
- The document references EU Regulations 2017/745 and 2017/746, which classify medical devices based on their risk and outline the necessary safety standards for these devices, including considerations for battery removability.
This ensures a balanced approach, addressing both user safety and operational considerations, while complying with regulatory frameworks to maintain device functionality and integrity.
Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214
Region: EU Harmonized (27 Markets)
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