Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
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.