Episode 313

Systematic Literature Review for EU MDR

Global Medical Device Podcast powered by Greenlight GuruApr 5, 2023 · 38 min

Episode Description

What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps? In today’s episode, you’ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting.

In today’s conversation, we covered topics like where information for the literature review comes from, the types of tools used to make evaluations, and more. Listen to the episode to hear what Ethan has to say about the process of performing a CER, the mistakes and pitfalls he sees people make in the process, and what kinds of actionable steps companies can take.

Some of the highlights of this episode include:

What clinical evaluation reporting is
The big change in EUMDR
The process of performing a CER
Where people go to get the data for a CER
How to tell if a search is comprehensive enough
What mistakes Ethan has seen people making
The process once the deliverable is submitted
How much time it takes for evaluations to go through
Advice for companies going through the process

Memorable quotes from Ethan Drower:

“In comparison to the FDA, the big change, the big difference that’s happened with EUMDR is kind of a renewed scrutiny and focus on your actual data.”

“It’s a compilation game, which is why nobody likes doing it. Because you have to bring in so many different pieces of data and different plans and that’s why it’s a difficult document to write.”

“Once you’ve gone through the nightmare of pulling all this information together, now somebody has to read it.”

“Don’t expect that what you searched and your process in the past, don’t expect it to just work and be glossed right over. It needs to be exceptionally thorough, and it needs to be iron tight.”