European Union - Medical Directive Regulation
All medical devices entering the EU market have to pass the conformity assessment procedure and bear the CE mark. Earlier, essential requirements as well as the conformity assessment procedure were described in the Directive 90/385/EEC for active implantable medical devices and the Directive 93/42/EEC for medical devices.
To ensure better protection of public health and patient safety the EU Commission established Regulation (EU) 2017/745 on medical devices (MDR) on April 5, 2017. The MDR repeals Council Directives 90/385/EEC and 93/42/EEC and should be effective from May 26, 2020. However, the COVID-19 pandemic has postponed the MDR to become effective from May 26, 2021.
Devices that were legally placed on the market before the effective date can be sold for up to five years after the MDR takes effect, but the certificates will be terminated on May 25, 2024.