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: EU MDD</h1>
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 […]
Can multiple different devices be on a single EU MDD/MDR DoC?
March 21, 2023 Can multiple different devices be on a single EU MDD/MDR DoC? For a Declaration of Conformity (DoC) to a European Directive like 93/42/EEC on medical devices or to a European Regulation such as 2017/745 on medical devices, multiple different devices may indeed be encompassed by a single DOC. The Blue Guide […]
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 […]