January 25, 2024 EU MDR Virtual Importers While I can see potential benefits of voluntarily creating an importer (along with the additional regulatory burden) to add a layer of compliance checks and balances, I strongly advise against the basis being an assertion that end users need regulation because they have, as one person […]
<h1 class="entry-title">Category: EU MDR</h1>
UK and EU End Users Are Not Importers
January 25, 2024 UK and EU End Users Are Not Importers Generally speaking, end users are not considered to be importers. This is the same for the UK and the MDD/MDR alike. For example, the European Commission’s Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR, specifically […]
Notifying Your European Notified Body About Non-Significant Changes
January 11, 2024 Notifying Your European Notified Body About Non-Significant Changes Europe’s Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex VII sec. 4.9) for Notified Bodies (NBs) to require a manufacturer to notify the NB about certain kinds of changes [e.g., QMS, product range, device design (including labeling), intended use or […]
“Declaration of Conformity” vs. “Certification of Conformity”
April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]
Declarations of Conformity: U.S. FDA vs. Europe
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 […]
EU MDR Accessories: Identification in the IFU
April 14, 2023 EU MDR Accessories: Identification in the IFU In general, for any class of EU MDR device, but especially for a class III device, the IFU must identify any accessories. Specifically, GSPR 23.4(f) requires (among other things) that, where applicable, the IFU shall contain information allowing the healthcare professional to select the […]
EU MDR Device “Lifetime” vs. “Shelf-life”
April 13, 2023 EU MDR Device “Lifetime” vs. “Shelf-life” Distinguishing between “lifetime” vs. “shelf-life” is important to realizing proper EU MDR compliance. For example, regardless of device class, implantable device lifetime needs to be addressed in the information supplied to the patient [except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, […]
EU MDR Basic UDI-DI “essential design and manufacturing characteristics”
April 7, 2023 EU MDR Basic UDI-DI “essential design and manufacturing characteristics” According to the MDCG (2018-1), the Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and […]
eIFU MDD & EU MDR Notified Body is Required (as applicable)
April 6, 2023 eIFU MDD & EU MDR Notified Body is Required (as applicable) Both Regulation (EU) 207/2012 (the eIFU regulation for the MDD) and Regulation (EU) 2021/2226 (the eIFU regulation for the EU MDR) require that conformity with those regulations be reviewed by a European notified body where applicable (i.e., for those device […]