EU Deadline Approaching for Portable Batteries in Medical Devices and IVDs

By Jakub Kacki and Evangeline Loh

Background on battery regulation

In Europe, the Battery Regulation 2023/1542 was released in July 2023 with various deadlines to replace the Battery Directive 2006/66/EC. One fundamental aspect is that the legislation was promulgated as a Regulation and aligned to the New Legislative Framework (NLF). Recital 53 explained that this would help ensure “batteries are stored, used and discarded in a manner which is safe from the point of view of protecting human health and the environment.”

As with much of the NLF including the European Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR), the new regulation requires that batteries must be categorized in order to understand the available routes to conformity assessment. Article 3 of the regulation includes an extensive set of definitions. Technical documentation must be compiled to support compliance and a Declaration of Conformity (DoC) issued. Certain batteries can be self-certified while other batteries would require the review of a notified body, and the CE marking would be affixed accordingly.

Medical devices, IVDs and batteries

In general, it is expected that most of the batteries used in medical devices and IVDs are portable batteries (Article 3(9)) or portable battery of general use (Article 3(10)). Portable batteries are “sealed, weighs 5 kg or less, is not designed specifically for industrial use.” General use would add to the characteristic that the battery has a common format: 4,5 Volts (3R12), button cell, D, C, AA, AAA, AAAA, A23, 9 Volts (PP3).

Manufacturers of portable batteries would generally use the Module A conformity assessment procedure (self-assessment with self-declaration of compliance) to demonstrate compliance with the regulation. Hence, manufacturers would compile the technical documentation, issue the DoC to the legislation and affix the CE marking.

Note: Notified body assessment of Due Diligence Articles 48, 49, 50 and 52 (all batteries) will be required and mandatory from August 18, 2025 for manufacturers (and other stakeholders within supply chain) with net turnover above EUR 40 million annually. Additionally, the manufacturer can request voluntary assessment by the notified body to Articles 6-10 and Articles 12-14.

August 2024 for compliance of portable batteries

By August 18, 2024, portable batteries need to be compliant with the EU Battery Regulation 2023/1542. This implies that portable batteries must possess the technical documentation for compliance to relevant articles of the regulation, DoC, and CE marking. As a medical device or IVD manufacturer you must review for compliance of the battery and ensure there is the CE marking, or you accept responsibility as the manufacturer and affix the CE marking.

In addition, it is expected that the battery and device or IVD are separately marked with the CE marking.

Concluding remarks

As our series last year discussed, legislation in addition to the MDR and IVDR must be considered for compliance of medical devices and IVDs, respectively in the EU. Compliance is multifactorial. Also, at the time of writing, there are no notified bodies designated to the Battery Regulation.

For medical devices and IVDs, the Battery Regulation is one additional legislation which must be considered. In addition, this article didn’t address other requirements of the Battery Regulation, for example, restrictions on substances, due diligence and risk management.

UL Solutions and the EU Battery Regulation

UL Solutions provides domain expertise regarding the EU Battery Regulation, offering product and documentation assessments as well as software to support reporting, auditing and related requirements. To learn more, review our prerecorded webinar.

Jakub Kacki is business development manager, Consumer, Medical & Information Technology at UL Solutions.