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Sweden updates medtech software regs guidance to “clarify ambiguities”

This article was originally published in Clinica

Executive Summary

The Swedish Medical Products Agency (Läkemedelsverket, or MPA) has issued updated guidance on the regulation of standalone software with a medical purpose that qualify as medical devices, to reflect issues that have arisen in relation to such products in recent years as a result of the rapid development of the field and to clarify "remaining ambiguities".