Pause Europe’s New Medical Device Rules Amid Outbreak: Industry

Europe’s upcoming rules on registering medical devices like ventilators should be postponed until after the coronavirus pandemic, manufacturers say.

Device manufacturers worldwide are trying to ramp up production of essential products such as ventilators and get them cleared and shipped to health systems as quickly as possible. The new regulation, slated to take effect in May, could make it harder to get products needed to help with Covid-19 approved for sale amid a shortage of protective medical equipment and diagnostic tests.

The request to postpone the European rule is pending as President Donald Trump confused the issue last week by ...