March 29, 2023 ISO 13485: Design & Development Obligations of Contract Manufacturers As a general rule, a contract manufacturer who doesn’t perform any design and development for the subject device is thereby not required to have design and development in the scope of that contract manufacturer’s ISO 13485 certificate. So its certificate scope statement […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
EU MDR Transitional Extension Regulation (EU) 2023/607 and Expired MDD/AIMDD Certificates
March 27, 2023 EU MDR Transitional Extension Regulation (EU) 2023/607 and Previously-Expired MDD/AIMDD Certificates Even if an MDD/AIMDD certificate from 25 May 2017 expired before Regulation (EU) 2023/607’s March 15 (20?), 2023 entry into force, and as long as it wasn’t “withdrawn” for cause (e.g., see EU MDR Annex IX.3.7), then placing on the […]
EU MDR: Who Must Hold the Annex XI Part A Certificate?
March 24, 2023 EU MDR: Who Must Hold the Annex XI Part A Certificate? In addition to a production-focused quality management system certificate(s) (e.g., EU Quality Assurance Certificate or EU Product Verification Certificate), the EU MDR Annex XI Part A conformity assessment route requires the “manufacturer“, depending on device class, to also hold an: […]
Regulatory Misconduct Allegations
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 […]