Course Description

The European Medical Device New Regulation

Course Description:

This informative presentation outlines an initial assessment of the clinical evaluation aspects of the draft Regulation as a future substitute for the current Medical Device and Active Medical Device directives, made publically available on September 26th 2012.The main points covered are the changes in the clinical evaluation regulatory principles, followed by a gap analysis with ISO 14155 and a review of the clinical investigation process changes as proposed by the new regulation.

The EU commission’s initial aim is to get parliamentary approval of this document before its new elections in 2014, which some say is very unlikely. The scope of this presentation is not so much educational, but rather a call for awareness and where needed, a reaction to the European commission while the document is up for review. Neither does this presentation give an absolute interpretation of the clinical evaluation elements in the draft regulation; instead it should be taken as a possible view of the matters which provides listeners with “food for thought”.

Watch the Course Trailer:



Learning Objectives:
  • Understand changes in the clinical evaluation regulatory principles
  • Understand differences with ISO 14155
  • Review the process changes as proposed by the new regulation

Who Should Enroll:

All professionals involved in conducting clinical investigations under the medical device directives.


Prerequisite Knowledge/Requirements:

Basic knowledge in the current EU regulations is required.

Subject Matter Expert:
Danielle Giroud

38 min

Release date:

Related resources:

Case studies:

Change Currency:
Under review !!