Solution 'desperately required' for 'serious problem' with medtech standards in EU
This article was originally published in Clinica
Executive Summary
The European Commission's approach towards adopting international medical device standards has been too strict over the past few years and is causing a "serious problem" for the medtech sector, according to an independent report carried out on behalf of the commission. There are concerns that if the situation does not improve, harmonized European standards (hEN) may ultimately no longer be the preferred route for companies to show compliance with the essential requirements of the EU medical device directives.