Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). Today, we’re revisiting that deep dive to see what progress has been made since then.
Quick refresher on the European regulations
Europe enacted the medical device and IVD regulations in May 2017 but gave manufacturers and other stakeholders, including the regulators themselves, time to implement them. This meant the regulations were incomplete as first published, with placeholders noting where implementing regulation would – or could – be put into place down the pike to address specific topics and possible future delegating regulations might modify the regulations as experience was gained with them.
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