Battery of IVDs, medical imaging, and radiotherapy devices excluded from removability and replaceability by end-users

On 14 July 2026, the European Commission adopted a delegated act expanding the list of exemptions to the requirements concerning the removability and replaceability of portable batteries by end-users.

If not part of the full or partial derogation, batteries incorporated into medical devices have to be removed and replaceable by end-users.

Partial derogation: list has new categories, including IVDs, medical imaging, and radiotherapy devices

The amendment to Article11.2 adopted on 14 July expands the list to include new categories. Among these, there are professional medical imaging and radiotherapy devices as well as in vitro diagnostic medical devices. Consequently, the portable incorporated battery of such devices can be part of the derogation and therefore, be removed only by independent professionals, instead of by end-users.

Full derogation foreseen where continuity of power supply is necessary to ensure safety and data integrity

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. 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). Examples of devices that may benefit from a full derogation include:

• Implantable devices (e.g., cardiac pacemakers, implantable cardioverter defibrillators, implantable pulse generators).
• Hearing aid devices.
• Certain IVDs (e.g., transmissible agents detectors in blood transfusions, blood glucose meters for diabetic patients).
• 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.

Next steps and application

The delegated act has now been submitted to the European Parliament and the Council of the European Union for scrutiny. If there is no objection, the act will be published in the Official Journal of the EU and enter into force 20 days after its publication.

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