Ensuring the safety and efficacy of healthcare products is of utmost importance. The clinical evaluation process of medical devices is vital for demonstrating the device’s safety and performance in accordance with the regulatory requirements. How are device makers navigating this complex process effectively.
EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.
MedTech Intelligence recently sat down with Peter O‘Blenis, CEO of Evidence Partners to discuss challenges reviewers face throughout their literature review process in the context of regulatory compliance, and to talk about the upcoming virtual event, Evidence Matters 2021.
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.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
If a device establishment is going to invest significant time and money into building a cleanroom or a controlled environment room, it makes zero sense not to perform proper monitoring of the environment.
In lieu of trials, some companies may be able to submit a CER.
In lieu of trials, some companies may be able to submit a CER.
