The Commission Notice C/2025/214, published in January 2025, provides guidance on the consistent application of the provisions on the removal and interchangeability of portable and low-voltage batteries pursuant to Article 11 of the Battery Regulation (EU) 2023/1542, as well as information on the procedure for requesting exemptions from these requirements.
The Commission Notice also refers to the MDR and, in particular, to the risk-based approach. It focuses on implantable medical devices and certain IVDs. If none of the previously defined exemptions for medical devices available on the market apply, but battery replacement is not possible for safety reasons, an application for the inclusion of this product family/category in a delegated act can be submitted by April 30, 2025. For this purpose, an application portal is available on the EU Commission website, where all information that may be helpful in assessing the merits of the application for an additional exemption can be provided.
Manufacturers of affected devices have approximately seven weeks left to do so. However, you should allow sufficient time to prepare and compile the necessary information before submitting your application.
