Practices and alternatives until EUDAMED is fully functional

The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED, a new traceability system for medical devices on the EU market. Nonetheless, there have been delays in its implementation. According to the latest news, EUDAMED will be fully functional by second quarter of 2024, and from that date onward, mandatory with additional time given to the manufacturers to comply with its registration obligations. In July 2022, the Medical Device Coordination Group (MDCG) published a new document on harmonised administrative practices and alternative technical solutions for IVDR. Specifically, such alternative solutions apply during the absence of EUDAMED. Indeed, the document guides Member States and other stakeholders to meet their obligations under the IVDR.

Practices and solutions to apply during the absence of EUDAMED

The list below gives an overview on practices and solutions which are relevant for manufacturers of in vitro diagnostic medical devices. In particular, the list includes actions for which manufacturers are responsible. All articles refer to the Regulation on In Vitro Diagnostic Medical Devices. However, the document refers to other solutions which are not included in the list below.

UDI-DI, device information, and SRN number

• According to Article 26, manufacturers shall assign a Basic UDI–DI for each device or class of device and provide it in EUDAMED. In addition, before placing a device on the market, the manufacturers shall provide the Basic UDI-DI to the UDI database. Eventually, they must verify the device information entered in EUDAMED.
  • Alternative solutions: Until the use of EUDAMED is voluntary, manufacturers should refer to the national provisions in Member States for product registration schemes. However, assigning a Basic UDI-DI is mandatory from May 26, 2022. Affixing UDI-DI on the label is instead mandatory from May 26, 2023 depending on the risk class.
• As stated in Article 28, economic operators (manufacturers, authorised representatives and importers) must submit the device information in EUDAMED and obtain a SRN (single registration number). Thereafter, they can use this SRN number when applying to a Notified Body.
  • Alternative solutions: For the device registration, economic operators can use the actor module on a voluntary basis and should refer to the national provisions in Member States. For the SRN number, they can refer to the MDCG Position Paper on EUDAMED actor registration and SRN.

Safety performance and market surveillance

• Article 29 states that manufacturers of IVD medical devices of Class C and D must draw up a summary of safety and performance (SSP). The SSP must be made publicly available via EUDAMED.
  • Alternative solutions: Manufacturers can provide the SSP upon request without delay or specify where this can be found. Nonetheless, this function is available on EUDAMED and manufacturers can use it on voluntary basis.
• According to Article 81, manufacturers of class D devices must submit a Period Safety Update Report (PSUR) in EUDAMED for the Notified Body to review.
  • Alternative solution: Manufacturers must submit the PSUR through alternative secure means, such as via secured email.
• As per Article 82, manufacturers must submit reports of serious incidents and corrective actions and periodic summary reports (PSR) in EUDAMED.
  • Alternative solution: Manufacturers should report serious incidents and field safety corrective actions to the respective/relevant national vigilance system. In addition, manufacturers can use the MIR form and the FSCA form. To submit the PSR, manufacturers must use national vigilance systems.
• Article 83 states that manufacturers must report any significant increase in the frequency or severity of incidents which could have a relevant impact on the benefit–risk analysis.
  • Alternative solution: Manufacturers must transmit trend reporting through the respective/relevant national vigilance system.
• As indicated in Article 84, manufacturers must submit a final report on the analysis of serious incidents and field safety corrective actions and any field safety notice in EUDAMED.
  • Alternative solution: Manufacturers must transmit the final report and field safety notice via the respective/relevant national vigilance system.

In 2021, the MDCG published a similar guidance for MDR. Manufacturers of medical devices can consult our analysis here.

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