Essentials of European Medical Device Regulatory Affairs

MDR - Transition Strategy

• Is my QMS and technical documentation ready? • Is my supply chain ready? (distributors, importers) • When does my certificate expire? • Is my current Notified Body designated to the MDR? • Does my current Notified Body have the correct scope for my devices? • Do I want to make any significant design changes soon? • What is my plan for new devices?

Notified Body Designation: https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.main

The Organisationfor Professionals inRegulatory Affairs

Guidance MEDDEVs • The MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. • The MEDDEVs are drafted by authorities in conjunction with all stakeholders (industry associations, health professionals' associations, notified bodies and European standardisation organisations). • MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process • The guidelines are not legally binding. However, it is expected that the guidelines be followed, ensuring the uniform application of relevant directive provisions. • Much of the MEDDEV Text has been incorporated into the MDR

The Organisationfor Professionals inRegulatory Affairs