Under the EU MDR, literature reviews are recommended components for clinical evaluation, post-market surveillance, post-market clinical follow-up, and PSURs. The need to review scientific literature to support multiple processes can be burdensome, but a well-constructed plan may allow manufacturers to leverage a single literature search across multiple EU MDR deliverables.
This article outlines an MDR compliant, systematic literature review process. Access the article here.
The article is free!
Simply fill in the form below, verify your email address
and you’ll be sent a link to download the article.
- 80Medical device literature reviews for EU CERs present a challenge to many manufacturers. The literature review component of your CER will undergo robust scrutiny by the Notified Bodies.This article outlines an MDR compliant, systematic literature review process. Access the article here.
- 47By Robert Zott, Director of Advisory Services Development Originally published September 10, 2018 At the time of this writing, there is 1 year, 8 months, and 18 days—that’s 626 days or 15,024 hours—before the new European Medical Device Regulation (MDR) will become the law of the land. For those affected by the tighter scrutiny of…
- 47By Minh Han, MD, FAAFP, Nerac Analyst Originally published June 24, 2019 On the weekend of April 26, 2019, the Marvel Cinematic Universe (MCU) released Avengers: Endgame, which became the highest grossing movie in an opening weekend ($357M in the U.S., $1.22B worldwide) and highest grossing movie of all time. What made the movie such…