The European Medical Devices Database (EUDAMED) is not expected to be operational and fully functional with all its 6 modules before May 2022. Nevertheless, the effective date of the Medical Devices Regulation (MDR 2017/745) remains May 26, 2021!
In the meantime, how can you be compliant with the MDR while it is not yet possible to exchange or submit UDI information to EUDAMED? In the following article we have summarized the harmonized administrative practices and alternative technical solutions to be used until EUDAMED is fully functional.
The Medical Device Coordination Group (MDCG) published the MDCG 2021-01 guidance in February 2021 with solutions to bridge the missing EUDAMED. The following alternative approaches apply for manufacturers and sponsors:
Note that for some points, the information must be entered into EUDAMED as soon as the corresponding functionality is available. In this case, it is important not to wait for the EUDAMED message to be published for full functionality. The submission of the information must be done as soon as possible.
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Field |
Actor |
Alternatives |
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Devices Registration
Actor Registration
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Manufacturers |
Devices and actors must be registered in EUDAMED as soon as the registration functionality is available. For manufacturers, the obligation for UDI assignment (Basic UDI and UDI-DI) of devices applies from May 26, 2021. The labeling requirements apply gradually, starting from May 26, 2021. They should refer to national provisions regarding product registration. |
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Summary of safety and clinical performance (SSCP) |
Manufacturers |
The summary of safety and clinical rerformance (SSCP) must be uploaded to EUDAMED as soon as the corresponding functionality is available. Upon request, the SSCP will be made available to the public. |
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Periodic safety update report (PSUR) |
Manufacturers |
For Class III devices and Class IIa and IIb implantable devices, manufacturers must submit the periodic safety update reports (PSURs) to the relevant notified bodies. |
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Reporting of serious incidents and field safety corrective actions |
Manufacturers |
Manufacturers must report serious incidents and safety corrective actions to the relevant national vigilance systems using the MIR/FSCA/PSR forms. |
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Trend reporting |
Manufacturers |
Manufacturers must submit trend reports to the relevant national vigilance systems. |
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Analysis of serious incidents and field safety corrective actions |
Manufacturers |
Manufacturers must submit the final report and field safety notices to the relevant national vigilance systems. |
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Application for clinical investigations |
Sponsors |
The application for clinical trials and the communication of relevant information should be made through the respective national procedures applicable to clinical trials. |
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Clinical investigations regarding devices bearing the CE marking |
Sponsors |
The notification of the relevant information should |
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Substantial modifications to clinical investigations |
Sponsors |
The notification of the relevant information should |
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Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination |
Sponsors |
The communication and upload of the relevant information should be done through the respective national procedures applicable to clinical trials. |
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Coordinated assessment procedure for clinical investigations |
Sponsors |
The procedure application is voluntary until May 27, 2027. It will then be mandatory. |
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Recording and reporting of adverse events that occur during clinical investigations |
Sponsors |
The reporting should be done through the respective national procedures applicable to clinical trials and in accordance with the MDCG Guideline on Safety Reporting for Clinical Trials of Medical Devices as set out in Regulation (EU) 2017/745.11. |
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