• Feature ArticlesFeature Articles

    EU MDR countdown: Readiness of medtech companies in Europe

    Around 75 days before the EU Medical Device Regulation’s May 2021 deadline, a survey was launched to evaluate EU-based medtech companies’ readiness for the impending changes. The findings showed that many manufacturers, particularly those with lower-risk devices, still feel unprepared for the new demands a year after the postponement. Notified bodies no longer seem to pose a major challenge, yet the regulation remains time- and cost-consuming, especially with regard to cli...