March 23, 2023 Regulatory Misconduct Allegations Making unsubstantiated claims about one’s device, promoting off-label uses, and selling medical devices with uncleared/unapproved features are examples of what the U.S. FDA calls “regulatory misconduct”. Specifically, regulatory misconduct is when a medical device manufacturer or other individuals marketing medical devices are doing so in a manner that […]
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 […]
Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life
March 22, 2023 Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life Biological evaluation for reusable devices may reasonably not be focused on “shelf life”. The heart of this question hinges first on general medical device principles regarding shelf life (or lack thereof) vs. stability over the device’s lifetime. Much can be said […]
Nonconforming Expiration Date
March 22, 2023 Nonconforming Expiration Date In short, if erroneous / outdated / violative / incorrect expiry date (or other related data on the label) are within reasonable risk acceptance criteria (safety, performance, regulatory), then such product can be accepted as-is and left alone. But if the risk acceptance criteria are exceeded, then corrective […]
EU MDR Classification of Accessories – “In Their Own Right”
March 22, 2023 EU MDR Classification of Accessories – “In Their Own Right” As noted previously, pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used. […]
Problem Containment Actions for Controlling Regulatory Impact
March 21, 2023 Problem Containment Actions for Controlling Regulatory Impact Today I received a question wrestling with the fact that problem containment actions tend to primarily focus on product containment and patient impact/risk, while not so much on containment actions aimed at controlling regulatory risk. This reminds me of ISO 13485’s deliberate distinction between […]
EU MDR Notified Body Demanding Use of Harmonized Standards
March 21, 2023 EU MDR Notified Body Demanding Use of Harmonized Standards Your notified body seems to be employing a classic infamous misuse of harmonized standards for the MDD and/or EU MDR. I generally advise our clients to respectfully, carefully, and legislatively, push back on such misuse. But without seeing the full details […]
EU MDR Classification of Accessories
March 21, 2023 EU MDR Classification of Accessories Pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used.
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 […]
Shelf Life Isn’t Always Required on Medical Device Labels
March 13, 2023 Shelf Life Isn’t Always Required on Medical Device Labels FDA’s medical device label regulations at 21 CFR §801.18 include the language, “…Whenever the label of a medical device includes a printed expiration date…”, thereby leaving open the possibility that a medical device label might not include an expiration date. In alignment […]