Swedish Presidency targets software-based healthcare IT system regulation
This article was originally published in Clinica
Executive Summary
A central part of the mission of the Swedish Competent Authority for medical products, during the Swedish six-month Presidency of the European Council, is to highlight and debate the need for medical information systems to be CE marked under the medical device directives. This is a subject that has been tabled by the Swedes as they prepare to take over the European Council Presidency on July 1.