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  • Article Galaxy Blog

May 26, 2020 is an important date for regulatory professionals. It’s the deadline for complying with the new European Medical Device Regulation (EU MDR). The new EU MDR, which replaces the Medical Devices Directive (MDD), expands regulations to focus not only on device pre-approval, but on the entire product lifecycle.

One big change in the new European MDR is a vastly increased requirement for clinical evidence. Moving forward, those involved in the preparation of Clinical Evaluation Reports (CER) or other regulatory submissions will need to conduct and maintain living literature reviews.

This significant change in policy has created an urgent need among many CER professionals to build a more efficient literature review process. But many are struggling to do so. According to a recent RAPS/KPMG survey, a whopping 83% of respondents cited “remediating and managing updates to technical files and Clinical Evaluation Reports” as a significant challenge.

Recently, we joined forces with Evidence Partners to simplify and accelerate the end-to-end literature review lifecycle (read more about that here: Conducting Better Systematic Reviews in Less Time, with Fewer Resources).

 

Save the Date: March 25

If you’re looking for ways to improve efficiency in your literature review process, join us on March 25 for complimentary webcast on best practices for building an efficient literature review process. Our very own Rogier Van Erkel and Evidence Partners CEO, Peter O'Blenis will share expert advice and clear strategies you can put to use right away.

Peter

Peter O'Blenis
CEO Evidence Partners

rogier

Rogier Van Erkel
CSO Research Solutions

Key topics include:

  • Understanding the role of literature reviews in meeting clinical evidence requirements for EU MDR compliance
  • Identifying inefficiencies and opportunities for savings in current literature review processes
  • Automating time- and labor-intensive aspects of the literature review process
 

Webcast Details

DATE: Wednesday, March 25

TIME: 12:00 PM - 1:00 PM Eastern Time (US & Canada) 

The webcast is free and includes access to handouts, presentation slides and the on-demand recording for one year.

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Topics: Reprints Desk Research Solutions savings literature review evidence partners European Medical Device Regulation webcast Clinical Evaluation Reports Article Galaxy Enterprise