<h1 class="entry-title">Category: CE Mark</h1>

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 […]

EU MDR Scope and Applicability of GSPR 10.4.1

July 12, 2021 EU MDR Scope and Applicability of GSPR 10.4.1   I think there is a good possibility that GSPR clause 10.4.1’s reference both to “invasive” and to “come into direct contact with the human body” may just be an ambiguous redundancy in describing invasive devices, as I have a hard time imagining an […]

EU MDR CE Marking On Advertising Materials

July 9, 2021 EU MDR CE Marking On Advertising Materials   Though many of us have undoubtedly observed the placement of a CE mark on promotional flyers, I suggest that such a practice is contrary to the basic product-inscription intentions established by the European authorities for use of the CE mark.  Accordingly, I recommend against […]

EU MDR Applicability for Changes to Pre-26 May 2021 Devices

July 7, 2021 EU MDR Applicability for Changes to Pre-26 May 2021 Devices   Remember (see my post from yesterday) that EU MDR requirements (like EU MDR vigilance procedures, EU MDR corrective action reporting, etc.) generally doesn’t apply for changes involving device units that were legally placed on the market and put into service in the Union prior […]

EU MDR & MDD Redundant Certification

July 6, 2021 EU MDR & MDD Redundant Certification   An MDD-certified device is generally eligible for participation in the EU MDR Article 120(2) and/or (3) 2024 transitional buffer.     An MDD-certified device is generally eligible for participation in the EU MDR Article 120(2) and/or (3) 2024 transitional buffer.  In that case, the MDD […]

EU MDR Critical Component Changes to MDD-Installed Devices

July 6, 2021 EU MDR Critical Component Changes to MDD-Installed Devices   If changing the supplier of a critical component that will be, or could be, subsequently used for component replacement in devices already installed (i.e., already put into service) in the Union prior to 26 May 2021 under an MDD Declaration of Conformity (DoC) […]