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The EU medtech proposals: a quick run-through the device regulation requirements

This article was originally published in SRA

Executive Summary

The two key documents relating to the European Commission's proposals to revise the current medical device directives may run well over 100 pages in length each, but in line with the commission’s simplification plan to cut the number of legislative texts applicable to any one sector, the array of EU medtech rules have been consolidated into two main medtech regulations1-3.

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