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 […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
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 […]
Intended Use vs. Indications For Use: What’s the Difference?
August 5, 2021 Intended Use vs. Indications For Use: What’s the Difference? Successful premarket regulatory strategy and authorizations weigh heavily on proper understanding between the term “Intended Use” as distinguished from “Indications for Use”. That said, it can be difficult to find clearly defined explanations of these terms. For the U.S. FDA jurisdiction, I […]
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 […]
FDA’s 21 CFR §820.72 Metrology Requirements vs. Test Method / Process Validation
July 29, 2021 FDA’s 21 CFR §820.72 Metrology Requirements vs. Test Method / Process Validation My experience has been that FDA views a test method as a process that produces an output. And if such output can’t be fully verified, then it must be validated. Since FDA’s 21 CFR §820.72 is not generally related […]
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 […]
FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage
July 27, 2021 FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage Before addressing FDA’s MDUFMA fees and SBD program for a firm’s premarket submission when at a pre-revenue / premarket stage, my suggestion is to first remember that if a product clearance or approval [510(k) clearance, PMA approval, etc.] hasn’t happened yet, […]
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 […]
EU MDR Changes to MDD DoC under EU MDR Article 120
July 22, 2021 EU MDR Changes to MDD DoC under EU MDR Article 120 When considering the requirements for revising an MDD (or EU MDR) Declaration of Conformity (DoC) associated with device changes (whether significant or nonsignificant), it’s important to know that there must always be a valid DoC that accurately represents required details […]
ISO 13485 QMS Planning vs. Quality Plans
July 19, 2021 ISO 13485 QMS Planning vs. Quality Plans I think it’s important to remember that the general quality management system planning and set-up called for by ISO 13485 clause 5.4.2(a) is fundamentally distinct from clause 7.1’s product/project/object/output-oriented planning. If they were the same, then ISO TC/210 would not have separated and distinguished […]