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Want to find a place in the EU market for your IVD/med device? You’ll need to get through some new hoops first!
As the first quarter of 2017 drew to a close, the in vitro diagnostic (IVD) and medical device markets in Europe faced the advent of new regulations designed to improve post-market surveillance, traceability, and safety of high-risk devices.
Originally proposed five years ago, these regulations will take effect in three years (2020) for IVDs and five years for medical devices (2022).