April 20, 2023 Declarations of Conformity: U.S. FDA vs. Europe I received a question wondering whether the U.S. FDA mandates Declarations of Conformity (DoC) in the way Europe does, and whether U.S. and EU DoC can be combined into a single document. In short, no, the US FDA doesn’t, as a general rule, […]
EU MDR/IVDR Annex IX Full QMS vs. Annex XI Production Quality Assurance
April 20, 2023 EU MDR/IVDR Annex IX Full QMS vs. Annex XI Production Quality Assurance The assessment of the full QMS via Annex IX includes (among other things) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices and the corresponding documentation as well as the data and records […]
UDI for IVD Devices Used In-House: Part 3
April 13, 2023 UDI for IVD Devices Used In-House: Part 3 For those that would say that the part of an IVD assay/test used only in a manufacturer’s in-house lab isn’t in “commercial distribution” and thus asserting that UDI requirements don’t apply: That is definitely a thought provoking stance. But I’m thinking that such […]
UDI for IVD Devices Used In-House: Part 2
April 13, 2023 UDI for IVD Devices Used In-House: Part 2 Once the reagent kit components (i.e., essential parts of the finished IVD device) of an IVD are sent to the healthcare facility for clinical use, then the finished IVD is in commercial distribution (thus triggering the UDI requirements) as I understand it. Also, […]
UDI for IVD Devices Used In-House: Part 1
April 12, 2023 UDI for IVD Devices Used In-House: Part 1 The U.S. FDA’s and the IVDR’s requirements for UDI aren’t generally contingent on where the subject device is used. Instead, the requirements are contingent on the definition of “medical device” and “in vitro diagnostic medical device” (hereinafter “device” / “devices”). Specifically and plainly, […]
EU IVDR Accessory Definition Triggered for an Optional Item?
March 22, 2023 EU IVDR Accessory Definition Triggered for an Optional Item? Per Europe’s IVDR, the definition of accessory for an in vitro diagnostic device’ [Article 2(4)] is definitely not invoked when the potential accessory (e.g., a barcode scanner) is an optional add-on module or peripheral. Nor is the ‘accessory’ category triggered if the potential […]
Can multiple different devices be on a single EU MDD/MDR DoC?
March 21, 2023 Can multiple different devices be on a single EU MDD/MDR DoC? For a Declaration of Conformity (DoC) to a European Directive like 93/42/EEC on medical devices or to a European Regulation such as 2017/745 on medical devices, multiple different devices may indeed be encompassed by a single DOC. The Blue Guide […]
EU MDR PMCF Plan is Needed for Legacy Devices
February 28, 2023 EU MDR PMCF Plan is Needed for Legacy Devices In order for an EU MDR Article 120 “legacy” device (as defined in MDCG 2021-25) MDD certificate to remain valid, certain conditions upon which issuance of that legacy MDD certificate was based shall be maintained regardless of whether devices have yet been […]
What Changes are Allowed for EU MDR Article 120 Legacy Devices?
February 24, 2023 What Changes are Allowed for EU MDR Article 120 Legacy Devices? In general, from purely a legislative EU MDR / MDD perspective, if an EU MDR Article 120(2/3) MDD-certified transitional device has, “…no significant changes in the design and intended purpose…”, then it can be placed on the market or put […]
Recall Classification: EU MDR / IVDR
February 20, 2023 Recall Classification: EU MDR / IVDR Neither the EU MDR nor IVDR contain a formal risk-classification scheme for recalls. So in general, other jurisdictions’ (e.g., U.S. FDA, Health Canada) defined recall classification tiers are not a clear paradigm of the EU MDR/IVDR (yet the future finalization of the EUDAMED database might […]