Team-NB: Position Paper on Medical Device Lifetime
7 February 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.