[Emergo, UL] EU Deadline Approaching for Portable Batteries in Medical Devices and IVDs

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.

 

 

EU Battery Regulation and Medical Devices | Emergo by UL

EU Deadline Approaching for Portable Batteries in Medical Devices and IVDs

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