March 6, 2023 EU MDR EUDAMED Accuracy Monitoring – Article 31(5) I’m unaware of any EUDAMED functionality at this time that accommodates the Article 31(5) accuracy monitoring. With our clients, we’ve embedded procedures for the periodic accuracy check into a “CE Marking” SOP under Article 10(9), third paragraph, indent (a). Document the periodic accuracy […]
<h1 class="entry-title">Category: EU MDR</h1>
EU MDR PMCF Plan is Needed for Legacy Devices
February 28, 2023 EU MDR PMCF Plan is Needed for Legacy Devices In order for an EU MDR Article 120 “legacy” device (as defined in MDCG 2021-25) MDD certificate to remain valid, certain conditions upon which issuance of that legacy MDD certificate was based shall be maintained regardless of whether devices have yet been […]
What Changes are Allowed for EU MDR Article 120 Legacy Devices?
February 24, 2023 What Changes are Allowed for EU MDR Article 120 Legacy Devices? In general, from purely a legislative EU MDR / MDD perspective, if an EU MDR Article 120(2/3) MDD-certified transitional device has, “…no significant changes in the design and intended purpose…”, then it can be placed on the market or put […]
EU MDR Clinical Evaluation Report (CER) Frequency
February 21, 2023 EU MDR Clinical Evaluation Report (CER) Frequency The EU MDR doesn’t prescribe the frequency at which CERs are to be updated. Modeling this, the MDCG (2020-13) has left manufacturers the liberty to, “…Identify when updates to the clinical evaluation report shall be assessed during the surveillance and post certification monitoring activities and […]
Recall Classification: EU MDR / IVDR
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 […]
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 […]
Can a Customer Survey Be Used as Part of PMCF?
July 30, 2021 Can a Customer Survey Be Used as Part of PMCF? PMCF may not need to be full-blown prospective clinical investigation. Specifically, I would place such goals under the banner of the general types of non-investigational PMCF that I’ve mentioned before in my prior PMCF post(s). Indeed, such feedback could certainly be […]
EU MDR PMCF: To Waive or Not to Waive
July 29, 2021 EU MDR PMCF: To Waive or Not to Waive When is PMCF Required? When is PMCF Required? Do “PMCF” if, after proper premarket clinical evaluation, there remains residual risks and/or uncertainty about long-term clinical performance that may impact the benefit/risk ratio. If PMCF is indicated, then be sure the PMCF […]
EU MDR Strategy for Configurable Software
July 22, 2021 EU MDR Strategy for Configurable Software For my clients that manufacture software-only medical devices, I have sought and implemented what I feel is the ideal: The software design and architecture are such that there is one executable software file, but that can be configured via licensing to turn various modules on […]