Safety considerations

Examples of devices where a permanent connection between the product and the respective portable battery is required to ensure the safety of the user and the device include life-saving, life-sustaining devices, and safety-critical devices. Article 11(2) mentions professional medical imaging and radiotherapy devices where it is sufficient that portable batteries can be removed and replaced by independent professionals. Nevertheless, medical devices and in vitro diagnostic medical devices, as defined respectively in Regulations (EU) 2017/745 and (EU) 2017/746, cover a wide range of products which are used in applications with different levels of criticality. The uninterrupted operation of some medical devices is key when delivering care to a patient, and a risk-averse approach to medical devices is therefore proposed as appropriate. The classification systems provided by Regulation (EU) 2017/745 (Article 51 and Annex VIII) and Regulation (EU) 2017/746 (Article 47 and Annex VIII) can be used for this. The classifications use a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. Implantable medical devices (e.g., cardiac pacemakers, implantable cardioverter defibrillators, implantable pulse generators) and certain in-vitro diagnostic medical devices (e.g., instruments used for detection of transmissible agents for screening of blood for transfusion, blood glucose meters to be used with test strips for diabetic patients) are associated with high risks. A lack of continuity of power supply and a break of connection between the product and the respective portable battery therefore entails a high risk of compromising the safety of the patient (end-user). Implantable active medical devices and certain in-vitro medical diagnostic devices are considered to be relevant to the derogation in Article 11 (3). It is worth noting that the above-mentioned classification is determined by the intended use. It is the intended use, and not the accidental use of the device, that determines the device class. Additionally, and similar to implanted devices, hearing aids constitute medical devices whose useful lifetime is dictated specifically by medical reasons (i.e., progressive hearing loss). At the same time, replaceability of the battery could pose a safety risk to the patient. Hearing aid devices are therefore considered to be relevant to the derogation in Article 11(3). Smoke alarms, carbon monoxide detectors and gas alarms are safety devices that are designed for use in residential settings, alerting occupants to fire, smoke or hazardous gases. They allow people to respond appropriately and evacuate if necessary. Smoke alarms are harmonised construction products according to the Construction Products Regulation (CPR) (12). A harmonised standard (13) supporting the CPR requires that the internal power source of smoke alarms be replaceable by the user unless its operating life is 10 years or greater. For harmonised construction products where the harmonised standard is introducing replaceability requirements, these shall apply instead. Therefore, in smoke alarms which are designed for at least 10 years of uninterrupted operation matched by a battery with the same service life, and where continuity of power supply and a permanent connection between the product and the respective portable battery is required to ensure the safety of the user and the appliance, it is considered that the portable battery does not need to be removable and replaceable by the end-user. Furthermore, Article 2(4)(g) of Directive 2012/19/EU excludes from its scope ‘medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices’. Therefore, those devices should also be understood as relevant for derogation from the requirements in Article 11(1) of Regulation 2023/1542. It is also worth recalling that Recital 38 of Regulation (EU) 2023/1542 states that the general provisions of the Regulation should apply without affecting the safety and maintenance requirements for professional medical imaging and radiotherapy devices as defined in Regulation (EU) 2017/745 and for in vitro diagnostic medical devices as defined in Regulation (EU) 2017/746, and could be complemented with requirements laid down for particular products powered by batteries under implementing measures under Directive 2009/125/EC. Where other EU law lays down more specific requirements for safety reasons, regarding the removal of batteries from products, those specific rules should apply.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.