This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more
Helping your notified body working efficiently We all know that notified bodies are in short supply and they should work as efficient as possible. There is something we can all do to help: prepare documentation well. It sounds obvious, but I still have to explain to companies that notified body reviewers want to see clear, … Read more
Systems and procedure packs In other articles I discussed grouping devices into the Basic UDI-DI, and also the strategic importance of the Basic UDI-DI from a regulatory perspective. This article sets out how UDI is used for the identification of systems and procedure packs. Article 22 defines a system of procedure pack as a combination … Read more
The strategic consequences of specific Basic UDI-DI groupings As can be read elsewhere, a Basic UDI-DI groups devices with the same intended purpose and the same essential design and manufacturing characteristics into device families. Within this context a company can chose to apply various levels of granularity. This freedom should be used with great caution, … Read more
Basic UDI-DI MDCG guidance 2018-1 Rev. 4 starts with: ‘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 essential design and manufacturing characteristics.’ In order to help … Read more
EUDAMED is the IT system established by Regulation (EU) 2017/74) on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices and developed by the European Commission. A device identification system based on a unique device identifier (UDI) allows easier traceability of medical devices. Really, EUDAMED and UDI are in essence quite straightforward … Read more
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