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 […]
<h1 class="entry-title">Category: CE Mark</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 […]
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) […]
New European Medical Device Regulation 2017/745 Date of Application 26 May 2021
October 2018 updated 2020 New European Medical Device Regulation 2017/745 Date of Application 26 May 2021 European authorized representatives and others have recently cited an apparent lag in medical device manufacturer preparedness for the new European Medical Device Regulation 2017/745. ComplianceAcuity has always been on the cutting edge of organic compliance with European device […]