<h1 class="entry-title">Category: EU MDD</h1>

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, […]

eIFU MDD & EU MDR Notified Body is Required (as applicable)

April 6, 2023 eIFU MDD & EU MDR Notified Body is Required (as applicable)   Both Regulation (EU) 207/2012 (the eIFU regulation for the MDD) and Regulation (EU) 2021/2226 (the eIFU regulation for the EU MDR) require that conformity with those regulations be reviewed by a European notified body where applicable (i.e., for those device […]

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 […]

EU MDD and MDR “AFAP”

January 26, 2021 EU MDD and MDR “AFAP”   Check Your Existing Procedures:   To properly attend to what Europe’s outgoing Medical Devices Directive (MDD) and new Regulation 2017/745 (the EU MDR) require regarding the reduction of risk “as far as possible” (AFAP), it is first important to know what an organization’s corresponding acronym actually […]