When three EU medtech Directives become two Regulations - a quick run-through
This article was originally published in Clinica
Executive Summary
The two key documents relating to the EU Commission's proposals to revise the current medical device directives may run well over 100 pages long 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 Regulations.