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Spotlight on Europe

Major medical device regulatory changes that will impact manufacturers operating and selling within the European Union are being finalized and are expected to go into effect in 2017, at the earliest. Companies seeking to expand within the region, though, need to consider more than just regulatory factors. Individual countries’ demographics, healthcare systems and economies must also be understood.

The European orthopaedic market is healthy and expected to grow at a faster pace than the overall medical market for at least the next year, according to Research and Markets’ “Orthopaedic Markets in Western Europe 2010.” The majority of orthopaedic devices sold in the European Union are manufactured in member countries, while the remaining imports largely come from the U.S. and Switzerland.

This month’s Global Spotlight focuses upon the two largest medical device markets in Europe, Germany and France, as well as Ireland, which has seen greater foreign investment from all industries. Continue reading as three orthopaedic industry professionals provide a snapshot of the market in their countries.

Continue to check back for updates on European Union regulatory changes in development. For previous articles on the subject, read:

The Post-Market Imperative: Understanding the Requirements for Effective Post-Market Clinical Follow-Up.

Basic Anatomy of a Design Dossier

Notified Body Requirements for Clinical Literature Evaluation

MDD Regulations: What I Wish I Had Known