Team-NB: Position Paper on Medical Device Lifetime
8 January 2024
The MDR does not provide a specific definition of the lifetime of a medical device. However, as part of the general safety and performance requirements (GSPR – Annex I of the MDR), the regulation imposes obligations on the manufacturer regarding the lifetime of the medical device. Other articles also refer to the lifetime of medical devices (Article 18 Articles 83 and 86 and Annex XIV Part B Sections 5 and 6 and Annex II (6)).
The position paper, published on 15 December 2023, intends to provide an overview of existing guidelines and standards and to illustrate the circumstances of various types of medical devices.
Existing guidelines and standards dealing with the topic of the service life of medical devices are e.g: MDCG 2022-21, MDCG 2020-8, IMDRF Technical Document on Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices and EN ISO 20417:2021 (Medical devices — Information to be supplied by the manufacture).
The position paper addresses various scenarios, taking into account other existing standards and different types of medical devices (e.g. software, implants or active medical devices), with risk assessment and post-market surveillance as an essential part of it.