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EU Court Judgment Challenges Status of Standards: How Will It Hit Medtech?

 
• By Amanda Maxwell

An EU legal judgment in the construction industry is changing the standards game. Until now, there has not been an official link between standards and EU law. That has changed. But how is medtech affected?

Two critical harmonized standards for the EU medtech sector, the European quality system standard, EN ISO 13485, and the European standard on medical device symbols, EN ISO 15223-1, are due to be listed in the Official Journal of the EU next month. But a legal case in the construction industry is raising fundamental questions about the nature of standards in the EU. The answers to these questions could impact the medtech industry.

The case (Case C-613/14 James Elliott Construction vs. Irish Asphalt) raises questions over the legal status and copyright protection of...

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