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.