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European Commission explains management of legacy devices in Eudamed

Posted 12 February 2021 | By Michael Mezher 

European Commission explains management of legacy devices in Eudamed

The European Commission this week posted a new document explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database.
 
After being delayed in 2019, Eudamed, a critical component of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched with the first of its six modules operational in December 2020. The remaining five modules are expected to roll out by the database’s May 2022 date of application. (RELATED: Eudamed launched with actor registration module live, Regulatory Focus 1 December 2020).
 
The database is intended to increase transparency for medical devices and diagnostics and improve coordination between EU member states.
 
While MDR and IVDR will eventually replace the current directives, Directive 93/42/EEC, Directive 90/385/EEC and Directive 98/79/EC, devices and IVDs with a valid certificate under the directives may continue to be placed on the market. Such devices are considered legacy devices and are subject to different Eudamed requirements than products with certificates issued under the new regulations.
 
In April 2019, the Commission’s Medical Device Coordination Group (MDCG) issued guidance on the registration of legacy devices in Eudamed. Manufacturers must register legacy devices in Eudamed in the case of a serious incident involving the device or if the device is subject to a field safety corrective action. Legacy devices must also be registered in Eudamed 18 months after the date of application of MDR or IVDR, or within 24 months of after the publication of the Article 34(3) notice if Eudamed is not fully functional by the date of application of MDR. (RELATED: EU device coordination croup offers Eudamed guidance, Regulatory Focus 15 April 2019; Legacy devices: How MDR alters the landscape, Regulatory Focus 11 March 2020).
 
In general, the Commission says that, “Legacy Devices are subject to the MDR or IVRD registration requirements with some exceptions such as the assignment of a Basic [universal device identification-device identifier] UDI-DI and a UDI-DI.”
 
However, legacy devices without a Basic UDI-DI or UDI-DI will still be required to have a Eudamed DI, which is equivalent to a Basic UDI-DI, and a Eudamed ID.
 
“Therefore, a Basic UDI-DI will never be applicable and never be assigned to a Legacy Device, only Eudamed DI. On the other hand, a UDI-DI can be used to identify a Legacy Device in Eudamed,” the document states.
 
The document also explains how to link “regulation devices” to legacy devices after they become compliant with MDR or IVDR and provides information about the format of the Eudamed DI when it is not generated from a UDI-DI.
 
EC

 

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