The agency’s intent is to decrease regulatory burden while promoting patient access to products.
The device approvals address critical patient need.
The device has been exhibiting a lockup condition during patient use, leading to potential serious injury or death.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
A recent paper released by Duke University cites the promise of AI, but urges policy changes in order to bring AI-enabled clinical decision software to fruition.
The disgraced former CEO once oozed total confidence about her company and product, and in latest released footage says “I don’t know” more than 600 times during a 2017 deposition.
“We don’t know how long the shutdown is going to continue,” says the association’s President and CEO Scott Whitaker.
The challenges will continue to keep medtech manufacturers and other stakeholders in the healthcare industry on their toes.
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.