February 20, 2023 Recall Classification: EU MDR / IVDR Neither the EU MDR nor IVDR contain a formal risk-classification scheme for recalls. So in general, other jurisdictions’ (e.g., U.S. FDA, Health Canada) defined recall classification tiers are not a clear paradigm of the EU MDR/IVDR (yet the future finalization of the EUDAMED database might […]
<h1 class="entry-title">Category: EU IVDR</h1>
EU eIFU Regulation: Broader Than Many Think
March 22, 2022 EU eIFU Regulation: Broader Than Many Think Everyone seems to know that Europe’s Regulation (EU) 2021/2026 covers requirements for when eIFU are provided instead of paper IFU. But did you know that the Commission also demands a certain level of conformity with that Regulation also for when eIFU is provided in […]
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 […]
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