Almost after a year-long delay EUDAMED is finally here and has launched its first of its six modules in December 2020. Recently, the EU Commission posted a guidance document explaining how to manage the registration of legacy devices in the released EUDAMED module.
While the remaining 5 modules are yet to be launched and expected to be rolled out by May 2022, the EU Commission expects the industry to start using the first module. The EUDAMED database increases transparency for medical devices and IVDs between member states and regulatory authorities worldwide for traceability purposes.
The devices currently cleared under the directives (i.e., Directive 93/42/EEC, Directive 90/385/EEC, and Directive 98/79/EC) and which still hold a valid certificate under these directives are referred to as legacy devices and are subject to different EUDAMED requirements than products with certificates issued under the new regulations.1
Manufacturers are required to register their 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.1
Legacy devices are subject to the same requirements as those under the new regulations with some exceptions such as the assignment of a Basic UDI-DI (universal device identification-device identifier). Devices without a Basic UDI-DI will still be required to have a EUDAMED DI which is equivalent to that of the Basic UDI-DI.1
While the long wait for EUDAMED is over, the industry is now ready to start registrations using the new module. It will be interesting to see how the EUDAMED -DI will be transferred to a Basic UDI-DI once the product has completed its transition from directives to the new regulations.
EMMA International is here to assist you in your EU MDR transition journey. Call us today at 248-987-4497 or email us at firstname.lastname@example.org to know more about how we can help!