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Thank you for all who have responded.
@Amanda Hays, thank you for sharing the MDCG Q&A document. The IVD definition in the MDCG Q&A document seems very broad. It defines as 'In vitro diagnostic medical device (IVD) is a medical device as defined in point (1) of Article 2 of Regulation (EU) 2017/745 on medical devices and, more specifically, according to Article 2 (2) IVDR, any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;'. It seems many biomarkers can fall in the 'concerning a physiological or pathological process or state' or 'to define or monitoring therapeutic measures' categories. However, later in this document for the question 'What are examples of assays used in clinical trials which are IVDs', the answer further limited IVD to 'assays providing information for clinical trial related medical management decisions (typically to select patients for enrolment in the trial, assign patients to a treatment arm, etc.) and/or may be used to guide follow up measures during and beyond the clinical trial.' It seems in many cases, whether IVDR applies or not is up to the user/sponsor's interpretation.
Original Message:
Sent: 02-21-2025 09:50
From: Amanda Hays
Subject: IVDR: CE mark requirement for Eppendorf tubes?
Hi,
I think the main question would be does the biomarker assay fall under IVDR scope? For example, does the assay have a medical purpose within the clinical trial (does it guide medical management decisions or follow-up)? There is much more that goes into IVDR and it can be very complex. I attached the MDCG Q&A document that has some explanation on what assays could be in scope under IVDR. That would be where I would start first.
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Amanda Hays Ph.D.
Scientific Officer
BioAgilytix
Overland Park KS
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 02-20-2025 11:56
From: Anonymous Member
Subject: IVDR: CE mark requirement for Eppendorf tubes?
This message was posted by a user wishing to remain anonymous
For our on-going clinical study in Europe, a partner/vender requested that a specific Eppendorf tube used for biomarker sample collections need to be CE marked due to the new IVDR regulation. My understanding is that the IVDR regulation applies to In Vitro Diagnostic Medical Devices, not general laboratory supplies. Any comments or advice? Thanks!