Removability and replaceability of portable batteries in medical devices

The EU Battery Regulation 2023/1542 applies to all batteries in the EU, including batteries incorporated into or added to medical devices and IVDs. The Regulation gradually phases out the 2006 Directive, with the first provisions applying already from February 2024.

Manufacturers of medical devices and IVDs must also verify whether the new battery requirements apply to them. Among others, they could be affected by the removability and replaceability requirements. Article 11 of the EU Battery Regulation specifies obligations on the removability and replaceability of portable and LMT batteries applicable to the natural or legal person who places devices on the market incorporating such batteries as of 18 February 2027. Typically, medical devices and IVDs include portable batteries, defined as “any battery that is sealed, weighs less than or equal to 5 kg, is not specifically designed for industrial purposes, and is neither an electric vehicle battery or a light vehicle battery or an SLI battery”.

Guidelines to facilitate the application of removability and replaceability provisions

In January 2025, the Official Journal of the EU released Commission guidelines to facilitate the harmonised application of provisions on the removability and replaceability of portable batteries and LMT batteries in Regulation (EU) 2023/1542.

Removability and replaceability by end users and professionals

Essentially, the obligation imposes that medical devices and IVDs should include – when possible – batteries that can be safely taken out of a device and replaced by the end user or an independent professional, without damaging or destroying the battery or the device. End users or independent professionals can also use tools to remove and replace the batteries. However, such tools must be either provided free of charge with the product or commercially available. According to the Commission guidelines, independent professionals are “independent operators who have the technical competence and qualification to repair the product where the battery is integrated into, and conduct their business on commercial basis and/or in commercial premises”.

In addition, the device has to provide clear advice that the removed waste battery must not be discarded with other waste and provide information on the correct handling, packaging, storage, and transport of the waste battery.

Derogations to removability and replaceability by end users

When it is necessary to ensure the user’s safety, it is sufficient that portable batteries can be replaced and removed only by independent professionals with commercially available tools, and not by the end user. This derogation is specified in Article 11.2 and includes devices operating in a wet environment, professional medical imaging and radiotherapy devices, and in vitro diagnostic medical devices. The criteria for the applicability for this derogation include:

  • Main purpose is the use in wet environment
  • Primarily use in wet environment
  • Washable or rinseable
  • Battery replaceability and removability by end-users would compromise the safety
  • No way to redesign the appliance with the current state of the art

However, there might be more medical devices and IVDs designed in a way that the portable battery is removable and replaceable only by independent professionals. For such cases, the Commission is empowered to adopt delegated acts to add further derogations to the removability and replaceability requirements by end users. Derogations can be adopted when:

  • There are concerns over the safety of end-users removing or replacing the portable battery, or
  • There is a risk that the removal or the replacement of the battery by end-users would negatively impact the safety requirements of the applicable product legislation (e.g., the MDR or IVDR)

When considering candidate products for such derogations, the Commission publishes calls for applications. Applicants can demonstrate how certain devices fulfil the conditions for a derogation, explaining how the removal or the replacement of the battery by end-users affects the safety requirements.

Full derogations to removability and replaceability provisions

According to Article 11.3, the removability and replaceability provisions shall not apply where continuity of power supply is necessary to ensure safety and data integrity. This includes, for instance, life-sustaining devices and safety-critical devices.

For some medical devices, uninterrupted operation is crucial when delivering patient care. If the battery is to be replaced and removed, it is necessary to take into account the potential risks this could cause to the patient (“risk-based” system). Some devices considered to be relevant to the full derogations are:

  • Implantable devices (e.g., cardiac pacemakers, implantable cardioverter defibrillators, implantable pulse generators)
  • Certain IVDs (e.g., transmissible agents detectors in blood transfusions, blood glucose meters for diabetic patients)
  • Hearing aid devices
  • Medical devices and in vitro diagnostic medical devices expected to be infective prior to end of life, and active implantable medical devices, by means of exclusion from Directive 2012/19/EU

Similarly, the derogation can also apply to medical devices whose function is data collection and supply and there is risk of data integrity loss. In such cases, the connection between the portable battery and the device cannot be interrupted (e.g. blood glucose monitors or devices for dialysis treatments).

Compatible battery and available spare parts

According to Article 11, all batteries and their respective devices have to be designed in a way that makes it possible to use both original and compatible batteries. In this sense, a battery is considered to be compatible if it does not pose a risk to the user’s or the device’s safety and allows the device to operate as intended.

In addition, Article 11 requires that portable batteries or LMT batteries are available as spare parts for a minimum of five years after placing the last unit of the equipment model on the market. The price must be reasonable and non-discriminatory for both independent professionals and end users.

Do you have questions on compliance of medical devices and IVDs? Contact us here or send an email to mdlaw@obelis.net.

 

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