1. Medical Device development and lifecycle management under the MDR and IVDR

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

For all devices, manufacturers must provide technical documentation as well as plan, establish document, implement, maintain and update a Post-Market Surveillance (PMS) system, to actively and systematically gather, record and analyse relevant data on the quality, performance and safety of their device throughout its entire lifecycle.

The following text and figure (Figure 1) exemplary and briefly describe the steps in the development of Medical Devices and their lifecycle management. (Adapted from [1]) from the manufacturer’s perspective. There are many instances (see Lesson 3, Figure 1) where patient input can and should be sought.

Figure1: The phases of the Medical Device lifecycle (adapted from [1])