April 13, 2023
EU MDR Device “Lifetime” vs. “Shelf-life”
Distinguishing between “lifetime” vs. “shelf-life” is important to realizing proper EU MDR compliance. For example, regardless of device class, implantable device lifetime needs to be addressed in the information supplied to the patient [except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors, and other devices adopted in this context by the Commission (e.g., Article 18)]. Similarly, the IFU for reusable devices generally requires information regarding device lifetime [e.g., GSPR 23.4(p)]. In contrast, the label is required to state the shelf-life [e.g., GSPR 23.2(i)]. Moreover, certain GSPRs demand scientific evidence/data supporting these attributes. Accordingly, it’s imperative to properly approach device “lifetime” vs. device “shelf-life”.
Toward that goal, I like to remember that all devices have a GSPR 6 lifetime, while not all devices have a GSPR 7 shelf-life. Device “lifetime” is generally applied to the duration of time a device is expected to remain functional once usage has started. Accordingly, lifetime is focused on questions of reliability (e.g., MTBF, etc.) during use. In contrast, “shelf-life” is generally applied to devices that have sterile or otherwise intrinsically time/age-sensitive attributes that can degrade while awaiting use. Thus, shelf-life is focused on questions of stability during transport and storage. Yet there could be some products whose inherent nature might cause lifetime to technologically merge with shelf-life; so, the foregoing narratives are just general rules.
For single-use devices, the GSPR 6 lifetime is simply the duration of the single-use. Yet that can be trickier than first meets the eye. For example, in the case of a long-term active implantable device that meets the EU MDR’s definition of single-use device (i.e., intended to be used on one individual during a single procedure). The GSPR 6 lifetime for reusable devices is governed by the device’s fitness after repeated use and reprocessing.