July 12, 2021 ISO 14971 Probability of Occurrence of Harm When tackling the estimation of probability of occurrence of harm during medical device risk management, I think it is important to remember that there is no one-size-fits-all approach. Instead, each manufacturer’s approach needs to be derived and appropriate based on the nature and complexity […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
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 […]
Health Canada Medical Device Importer Requirements for DTC Sales
July 7, 2021 Health Canada Medical Device Importer Requirements for DTC Sales When dealing with Health Canada’s medical device regulatory requirements (i.e., SOR/98-282 as amended from time to time, hereinafter the “CMDR”), there are four device classes: I, II, III, and IV. Therefore, when adapting a regulatory strategy from surrounding jurisdictions, be sure to […]
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) […]
Health Canada CMDR Updates 2021
June 28, 2021 Health Canada CMDR Updates 2021 Here’s a quick recap of Health Canada’s changes to the Medical Devices Regulations (SOR/98-282) that started coming into force on 23 June 2021: Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to […]
FDA & ISO DMR/MDF vs. “Design Output”
April 1, 2019 FDA & ISO DMR/MDF vs. “Design Output” Remember that the DMR is intrinsically linked to the design control process. The DMR is by formal definition a design output (see my preceding blog post). It unequivocally lives and breathes in direct relationship to the design control process. A properly-maintained DMR never becomes decoupled […]
FDA & ISO 13485 Design Outputs and the DMR
FDA & ISO 13485 Design Outputs and the DMR Remember that for FDA-regulated firms, design output is formally defined in 21 CFR 820.3(g) as, “…the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. […]
U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity
October 2018 U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity… Links to the draft guidance and corresponding Federal Register notice are provided below: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf https://www.federalregister.gov/documents/2018/10/18/2018-22697/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance
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