July 13, 2021 ISO 14971 Estimating Probability of Occurrence of Harm Based on the aforesaid flexibility (see my earlier blog post) allowed by ISO 14971 (e.g., see the third paragraph of ISO/TR 24971 section 5.5.2) for how to estimate probability of occurrence of harm, one might employ a variety of probability expressions. For example, […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
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 […]
ISO 14971 Probability of Occurrence of Harm
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 […]
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 […]
EU MDD and MDR “AFAP”
January 26, 2021 EU MDD and MDR “AFAP” Check Your Existing Procedures: To properly attend to what Europe’s outgoing Medical Devices Directive (MDD) and new Regulation 2017/745 (the EU MDR) require regarding the reduction of risk “as far as possible” (AFAP), it is first important to know what an organization’s corresponding acronym actually […]