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, […]
<h1 class="entry-title">Category: Standards</h1>
EU MDR Notified Body Demanding Use of Harmonized Standards
March 21, 2023 EU MDR Notified Body Demanding Use of Harmonized Standards Your notified body seems to be employing a classic infamous misuse of harmonized standards for the MDD and/or EU MDR. I generally advise our clients to respectfully, carefully, and legislatively, push back on such misuse. But without seeing the full details […]
Standards Aren’t Required, but are Recommended, to Show European Conformity
September 28, 2021 Standards Aren’t Required, but are Recommended, to Show European Conformity You may have heard a rumor that conformity with harmonized standards or other non-harmonized standards is mandatory when showing conformity with the IVDD, MDD, IVDR, or MDR. But that is not the intent of these European Directives and Regulations. Instead, Europe […]