Since May 25, 2017, the In Vitro Diagnostic Medical Device Regulation (IVDR) has been in force, which has now replaced the previous IVD Directive (98/79/EC, IVDD). There are significant differences between the IVDR and IVDD. This article presents these differences. In doing so, it provides manufacturers who placed their devices under the EU directive (IVDD)…
DetailsLaws and standards formulate requirements on how medical device manufacturers must define and document the development process. Notified bodies check these requirements during audits. This article on the development process provides tips on how to design the process and how to align it with other processes, such as the risk management process. 1. Development process:…
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