Introduction
Manufacturers of active medical devices requiring batteries might face challenges during design and development. This might be because they have not been aware of regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC. This article is about specific topics which needs to be taken into consideration while developing a medical device including non-standard batterie(s).
Design & development
The regulation is applicable to manufacturers who design and produce customized batteries for medical device themselves which they want to sell within the Union market.
Batteries (chargeable and non-chargeable) need to fulfil specific standards, such as IEC 62133 for rechargeable batteries (always in conjunction with IEC 60601-1) and IEC 60086-4 for non-rechargeable lithium batteries, i.e. a body thermometer with replaceable cell battery by this regulation. The regulation even requires that products incorporating portable batteries may be designed in such a way as to make the battery removable and replaceable only by independent professionals (i.e. professional imaging and radiotherapy devices and in vitro diagnostic medical devices). This means that maintenance requirements shall be determined carefully. Further it may include evaluation of the battery lifetime and/or replacement. Also, the charging interval needs to be determined and aligned with batteries’ capabilities.
It is crucial to analyse accurate information on different (re-chargeable) batteries when looking for battery options from different suppliers. Parameters from datasheets should be compared and real-world behaviour should be demonstrated.
When determining shelf-life of a medical device most think about transportation and packaging test of a medical device in order to predict the product’s material properties and shelf-life. But especially when a device incorporates replaceable batteries, manufacturer needs to ensure that the shelf-life is also covered by the initial battery lifetime itself.
Home use devices
Professional users often use medical devices which are maintained by professional technicians, i.e. in healthcare centers or hospitals. But when the device is designed for home use and lay users, additional requirements need to be considered. Usability tests should include battery replacement and IEC 60601-1-11 is the leading standard for active home use devices.
Labeling
In case of battery replacement it is from highest interest that an user knows how and where to get replacement batteries. If the manufacturer is using standard batteries (off-the-shelf) they only need to indicate information in the instruction for use which type of battery is to be used. But if this is about customized batteries it requires more details, i.e. website, service centers or information how to get to the health care professional.
For battery manufacturers chapter III of regulation (EU) 2024/1542 states marking and information requirements for batteries.
Longevity and risk management
Risk management means to analyse hazards and determine hazardous situations which can impact the safe and effective usage towards a patient. So, implications from using of batteries should be included into risk analysis.
Lifetime – medical device manufacturer needs to determine lifetime of a medical device and most think about accelerated aging and label peel testing. But how this is different from determination of longevity of a battery?
Mitigation of risks may include warning levels for end of batterie’s longevity. It should be noted that the amount of charging cycles is linked to a capacity decrease and this is considered to be a strong indicator to replace batteries. Common sense is a decrease of 20% of battery capacity before it becomes critical and batteries should be replaced. So, verification and validation should include the amount of charging cycles when determine the longevity and as a result the implementation of warning levels. Of course, longevity of battery does not mean necessarily lifetime of a battery, but in order to provide safety and effective use of a medical device, a determined longevity of batteries to be used in medical devices should require replacement action. The time between warning levels and replacement of batteries should be considered as well, as replacement of batteries in implants may require some time for scheduling.
Impact on longevity of a battery may depends on environmental factors as well, like temperature during charging. This might be neglected if you have implants which contains chargeable batteries as the body temperature is considered at 37°C. Also, the charging voltage is crucial. It is highly recommended to use only provided charging equipment by the manufacturer (which shall be aligned and/or approved with the battery manufacturer). Using wrong charging equipment may have direct impact on longevity of a battery and it is recommended to manufacturers that they have tested re-charging with different type of charging equipment in order to get information about the battery behaviour.
Usability
Usability formative studies should require the activity of battery replacement and re-charging in order to avoid obstacles and complaints from the beginning of sales.
Waste & Environment
Most think about directive 2012/19/EU, so-called WEEE directive (Waste Electrical and Electronic Equipment) when they develop an active medical device. But when developing customized batteries, regulation (EU) 2023/1542 needs to be taken into consideration when dealing with battery suppliers. The regulation aims to reduce adverse impacts on the environment, protect human health and environment.
New regulation (EU) 2024/1542
Nearly all type of batteries needs to fulfil the requirements out of this new regulation (except those for space and army purposes). Most interesting is that this regulation is similar to the medical device regulation (EU) 2017/745 regarding requirements:
The battery manufacturer needs to draw up a technical documentation, they require a Notified Body for conformity assessments, the economic operators like distributor, importer and authorized representative are also required including a management system for economic operators, risk management obligations, third party verification of battery due diligence policies and Union market surveillance.
Furthermore, it contains a chapter for management of waste batteries, green public procurement procedures and policies, a digital battery passport, carbon footprint calculation requirements and of course restriction of substances, similar to PFAS within medical device environment.
So, if your medical device requires customized batteries, medical devices manufacturers shall require evidence for fulfilment of this new regulation from potential battery suppliers. Request the technical documentation and its Declaration of Conformity of the battery required in order to conclude that the requirements have been met by your supplier and check if importer and authorised representative for your specific battery are existing.
If you need support during development of an active medical device (with or without batteries) get in touch with your preferred EUMEDIQ consultant or via our contact form on the website.