The guidance document MDCG 2021-25 was updated in October 2024 to reflect changes brought by Regulation (EU) 2023/607. Key updates include clarification that Article 19 MDR does not apply to legacy devices, adjustments to the transitional provisions for systems and procedure packs, and the requirement for manufacturers to implement a quality management system according to Article 10(9) MDR by 26 May 2024. These revisions aim to provide more clarity on the application of MDR requirements to legacy devices and those placed on the market before 26 May 2021.
