Approaching the regulatory world with passion: CERs and EU MDR processes
There has been significant evolution in the European regulatory landscape over the past 10 years, particularly in terms of requirements for clinical evaluation, driven in part by a series of medical device failures, which fuelled a perception, particularly amongst regulators and clinicians, that clinical evidence for medical devices was not receiving sufficient scrutiny in Europe.
In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Ethan Drower, co-founder and CEO of Cite Medical Solutions, a company providing full Clinical Evaluation Report (CER) services and industry literature review for European Union Medical Device Regulation (or EU MDR) processes.
The regulatory world, notes Drower, is not a flashy industry, nor is it one that often sees innovation, but coming to the medical device and regulatory space under a decade ago, Drower saw room for change here, nonetheless - particularly with new EU MDR processes coming into play.
Safety is incredibly important, but so is the ability to push limits, says Drower, and a Yin and Yang, balanced approach is key.
A CER is a complex and lengthy document, which can be broken into four stages: scoping, identifying all pertinent data to the device, appraising that data for relevance and value, and the final analysis and determination of what the data shows. Objectivity is critical, as the CER is not suitable for a marketer’s veneer.
You can listen to episode 146a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, Amazon Music, Podbean, and pretty much wherever you get your other podcasts!
