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, […]
<h1 class="entry-title">Category: Shelf Life</h1>
Shelf Life Isn’t Always Required on Medical Device Labels
March 13, 2023 Shelf Life Isn’t Always Required on Medical Device Labels FDA’s medical device label regulations at 21 CFR §801.18 include the language, “…Whenever the label of a medical device includes a printed expiration date…”, thereby leaving open the possibility that a medical device label might not include an expiration date. In alignment […]