Serge Bernasconi on Waiting One More Year for MDR

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ARTICLE SUMMARY:

Among the many unintended consequences of COVID-19 is the one-year postponement of the new European Medical Device Regulation. Here the CEO of MedTech Europe advises industry and regulators how they can use this time to smooth what was expected to be a bumpy transition, while also raising the question of what this might mean for the impending new diagnostics regulation.

Even before the onset of COVID-19, the impending implementation of the new European Medical Device Regulation (MDR) on May 26, 2020, and the transition from the existing Medical Device Directive (MDD) regimen was fraught with uncertainty. The entire European healthcare system was going to face what looked to be a jarring changeover at best for all those directly involved—product companies, payors, providers, and patients—as well as for adjunct participants such as investors.

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