Device manufacturers may see the EU MDR extension as an opportunity to take their collective feet off the gas. But slowing down or pausing a device’s testing program could jeopardize a successful transition and exacerbate the problem the deadline extension was designed to fix.
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.
Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous.
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
The pace of innovation in the ICU is orders of magnitude slower than that of the cath lab and OR, and the COVID-19 crisis has pushed, tested, and exposed ICUs for lacking state-of-the-art technology and resources.