Regulation (EU) 2017/746 - In Vitro Diagnostic Medical Devices Regulation (IVDR)
Primary EU regulation governing in vitro diagnostic medical devices, replacing Directive 98/79/EC and Commission Decision 2010/227/EU. Entered into force May 26, 2022. Establishes comprehensive framework for IVD device authorization and market surveillance.
📅 Effective / published: 2022-05-26
Manufacturers and sponsors placing medical devices on the the EU market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗