January 22, 2024 Are DoC Updates Required for Software Version Changes? In general, yes. I explain: Remember that the MDR requires the manufacturer to “continuously update the EU declaration of conformity”. For example, if the Technical Documentation (TD) is different for version 3.0 compared to 3.1 to 3.1.1 to 3.2, then the […]
<h1 class="entry-title">Category: Declaration of Conformity</h1>
“Declaration of Conformity” vs. “Certification of Conformity”
April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]
Declarations of Conformity: U.S. FDA vs. Europe
April 20, 2023 Declarations of Conformity: U.S. FDA vs. Europe I received a question wondering whether the U.S. FDA mandates Declarations of Conformity (DoC) in the way Europe does, and whether U.S. and EU DoC can be combined into a single document. In short, no, the US FDA doesn’t, as a general rule, […]