March 24, 2023 EU MDR: Who Must Hold the Annex XI Part A Certificate? In addition to a production-focused quality management system certificate(s) (e.g., EU Quality Assurance Certificate or EU Product Verification Certificate), the EU MDR Annex XI Part A conformity assessment route requires the “manufacturer“, depending on device class, to also hold an: […]
<h1 class="entry-title">Category: CE Mark</h1>
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 […]
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 […]
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 […]
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 […]
Risks from an Inadequate Development Process for Software
July 19, 2021 Risks from an Inadequate Development Process for Software The most fundamental reason for medical device design and development controls (e.g., ISO 13485 clause 7.3; the U.S. FDA’s 21 CFR 820.30, etc.) is to control risks that come from an inadequate development process. That fact is unequivocally true and stands in stark contrast to […]