Legacy Devices: Impacts of MDR/IVDR on these Products
European Parliament and the council of In Vitro Diagnostic Devices (IVDR) introduced Regulation (EU) 2017/746 after a transition period of 5 years will become applicable on May 26, 2022. However the recent roll plan for transition out according to device class will facilitate the Manufacturers to become fully compliant with new regulations. The IVDs which are placed on the market from the date of application must follow all the applicable requirements described therein.
This White paper presents:
- Current requirements for legacy devices under new regulation.
- CE marked legacy devices under the new market with new regulations.
- New Identifiers for Legacy Devices &UDI system.
- Legacy device and classification under IVDR/MDR regulation.
- MDCG Guidance and Updates: 2022.
- New Additional Requirements for Legacy Devices.
- Registration requirements of Legacy devices.
