![]() ![]() The shelf life is particularly important for sterile devices that must remain sterile until first use, including during transport and storage. The shelf life ends with the first use of a device, for example, when its packaging is opened (e.g., dental filling materials for several portions across multiple uses). ![]() However, in Annex I, it does summarize the general safety and performance requirements and indirectly and incidentally define the term “lifetime”: The complicated definition of lifetimeĪs important as it is for manufacturers, operators, customers and authorities to know what the lifetime of a medical device is, it is just as difficult to precisely define (and thus establish) what constitutes the “lifetime.” Legal regulations mostly remain vague, and a lot of terms are used synonymously with “lifetime.” a) MDRĮU Regulation 2017/745 (MDR) does not explicitly define lifetime. If a purchaser at a hospital purchaser has a choice between two otherwise similar devices, they will choose the one with the longer lifetime. Indeed, in a lot of cases, it is one of the factors taken into consideration when deciding whether to purchase a device. The lifetime of a device is also an important factor for customers. In this case, how is the operator supposed to know when safety and performance are no longer guaranteed?Įven if operators think their device is still working perfectly: the lifetime specified by the manufacturer takes precedence. It is even more difficult if the manufacturer has not specified the lifetime in the accompanying documentation. This is probably also the reason many operators struggle with decommissioning. They cannot see how the safety or performance is compromised. Operators often have a hard time with this because the device seems to be working flawlessly. Operators also have to act at the end of the device's specified lifetime (e.g., by taking the device out of service). The manufacturer documents these service intervals in the accompanying information.
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