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2025 EU Guide: Shelf Life Lifetime Service Life Lifecycle - Casus . . . A device has a shelf-life of four years, but it expires within one year of opening, even if it is opened well before the four-year shelf-life A device has a shelf-life of three years due to its sterile packaging, but once opened, it is implanted and has a much longer expected lifetime
Medical Device Lifetime - BSI Shelf life is essential for sterile devices with an expiration date However, manufacturers must consider the efects of storage on their devices, whether sterile or not and how this may impact safety and performance
Shelf life guidance EU MDR, class 1 and class 2 Medical Devices This guidance provides a comprehensive overview of the factors that can affect the shelf life of a medical device, including chemical, physical, microbiological, therapeutic, toxicological, and biocompatibility considerations
MDR – Article 27 – Unique Device Identification system The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:
Unique Device Identification (UDI) Under EU MDR: A Distributor’s Guide The Unique Device Identifier – Production Identifier (UDI-PI): This is a variable code that identifies the unit of device production and can include information such as the lot or batch number, serial number, software version, and expiry date
EU MDR IVDR UDI The UDI assignment requirements went into efect when the EU MDR and EU IVDR regulations became active on May 26, 2021 for medical devices and will become active on May 26, 2022 for in vitro diagnostics
Questions and Answers: Commission proposes an extension of the . . . The Commission proposes to delete the ‘sell-off' date – doesn't this allow low quality devices to remain on the market for a very long time? The ‘sell-off' date is the end date after which devices already on the market but not yet with the final user should be withdrawn