Article on EU-MDR General Safety and Performance added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR General Safety and Performance, that describes the requirements that apply to all devices. They are in Annex I, which has three chapters. The article briefly describes the role of harmonized standards and common specifications. It concludes with recommendations for the manufacturer to start working on the technical documentation.