European Union National Differences and Potential Impact on CE Marking

B.A. Fiedler
  • January 2017, Elsevier
  • DOI: 10.1016/b978-0-12-804179-6.00009-5

Ch 9 Managing Medical Devices within a Regulatory Framework

What is it about?

Regulatory changes in the European Union (EU) Medical Device Directives (MDD) take on unique characteristics when implemented in different EU members states. These differences are highlighted by a review of the four leading EU nations--Germany, United Kingdom, France, and Italy. The research introduces variance in the product classification of the Advanced Therapy Medicinal Product and demonstrates how fundamental national characteristics—national population health, economic and world health statistic indicators, can influence medical device development through the application of the EU MDDs and thus, CE Marking. Interpreting this information, the author discusses several national strategies that may permit an informed entry in to properly targeted EU markets.

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The following have contributed to this page: Beth A. Fiedler