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 […]
<h1 class="entry-title">Category: Accessories</h1>
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 […]
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. […]
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.