EU Medtech May Have Standards Certainty Days Before MDR Applies
The EU’s Medical Device Regulation applies in just over a month’s time and the IVD Regulation in just over a year. But the standards underpinning them are way behind. Will they get the green light at last?
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The timetable for developing harmonized standards under the EU’s Medical Device Regulation was already tight, even with new 2021 MDR application date. But it now looks untenable, even for the most urgently needed standards.
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.
The European Council has paved the way for swift adoption of the proposal to amend the IVD Regulation, given the pressures the IVD sector is under. All eyes are now on the European Parliament.