EMERGO BY UL SUMMARY OF KEY POINTS:

  • MDCG explains how to understand Eudamed legislation;
  • Manufacturers must enter data in Eudamed 18 months after Date of Application, or after 24 months if Eudamed is delayed;
  • Devices relying on certificates based on the current Directives – “legacy devices” -  will be assigned a Basic UDI-DI and UDI-DI by Eudamed at the moment they are registered in Eudamed
  • The manufacturer can also assign a UDI;
  • Once they become certified according to the new Regulations they need to have a Basic UDI-DI and UDI-DI issued by a UDI issuing agency;
  • This ”new” UDI does not have to impact device labelling.

New guidance from European regulators addresses data entry timelines for the Eudamed medical device database, as well as how to develop and assign Unique Device Identification (UDI) data for "legacy devices."

Role of MDCG

The roles and responsibilities of the Medical Devices Coordination Group (MDCG) are laid out in articles 103 and 105 of the Medical Devices Regulation (EU) 2017/745 (MDR) and articles 98 and 99 of the In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). The MDCG comprises representatives of Member States. One of its tasks is to provide guidance in developing a common understanding of the MDR and IVDR.

As part of that role, the MDCG has now issued two guidance documents. The first is on the timelines for entering certain data into the Eudamed database by manufacturers, the other is about so called ‘”legacy devices” and their Unique Device Identification (UDI) data in relation to Eudamed.

Be aware that these documents only provide guidance; this is about how European authorities will understand the Regulations. However, these are not legally binding texts. Only a judge can interpret the law and this may result in a different position. But until then, industry is recommended to follow these guidance documents.

Timelines for entering data into Eudamed

Article 123(3)(d) of the MDR requires Article 29 as being applicable from the Date of Application (DoA) of the Regulation. Article 29 requires all devices to be registered in Eudamed. However, Article 123(3)(e) grants an additional 18 months’ transitional period for that registration. In order to solve this discrepancy, MDCG explains in its “Timelines for registration of device data elements in Eudamed” guidance that we should understand these conflicting requirements as follows: the 18 months extension (or 24 months if Eudamed is delayed) according to Article 123(3)(e) will be understood as leading. In other words, device data elements listed in Annex VI, Part A, section 2 and Part B will be required to be entered in Eudamed 18 or 24 months after Eudamed becomes applicable.

Legacy devices

In order to maintain Notified Body capacity as much as possible, devices that rely on a valid CE Mark for their certification under to the current Directives may be placed on the market after the DoA until their certificates expire (see Article 120(3) MDR and Article 110(3) IVDR). For these legacy devices, the normal UDI requirements do not apply. However, in order to register according to Annex VI, a Basic UDI-DI and UDI-DI would be the applicable access keys to certain sets of device-related data. This also appears to present conflicting requirements.

Pseudo UDI

According to MDCG’s “Registration of legacy devices in Eudamed” guidance, the group expects legacy devices to be registered in Eudamed 18 or 24 months after Eudamed becomes applicable (see above), or in case of a serious incident or field safety corrective action. In order to do that, these devices need two access keys, replacing the Basic UDI-DI and UDI-DI.

The Basic UDI-DI is the primary link between the dataset and the higher UDIs. The UDI-DI is the actual UDI of the device, but different configurations or packages may have other UDIs. In practice this will most likely result in a Basic UDI-DI for the basic dataset in Eudamed; a UDI-DI for the actual device; and other UDI-DIs that appear on the device label.

These designations will all be linked to the same Basic UDI-DI. The Basic UDI-DI will also be listed on the Declaration of Conformity and on the future MDR- or IVDR-related certificate. For legacy devices, Eudamed will generate these access keys:

  • Instead of the Basic UDI-DI, a Eudamed DI will be assigned;
  • Instead of the UDI-DI, a Eudamed ID will be assigned.

The Eudamed DI may be generated by Eudamed or by the manufacturer. This may be relevant in case the manufacturer has already assigned a UDI to its device. The Eudamed ID will always be assigned by Eudamed.

The Eudamed DI and Eudamed ID will consist of a code starting with “B” for “basic” or “D,” respectively, followed by the Single Registration Number (SRN) of the manufacturer, a number and a check digit. Once a legacy device becomes certified according to the Regulations it should be considered a new device from the perspective of Eudamed. A new Basic UDI-DI and UDI-DI must be assigned. MDCG has asked the Eudamed development team to create a functionality whereby a new version of the device data can be created by only changing the Basic UDI-DI and UDI-DI fields in the applicable records.

Practical considerations

Entering data in Eudamed will take time and must be done with great care. Manufacturers should develop strategies for efficient data entry. Two scenarios apply for legacy devices:

  1. The device will be sold out under the current Directives-related certificates before the 18 or 24 months after Eudamed becomes applicable, but will not be certified under the new Regulations; these devices will only be required to register in Eudamed in case of a serious incident or field safety corrective action. Some devices are more prone to these registrations than others, so the manufacturer may decide only to register if necessary. Firms may also decide not to assign a UDI to the device. On the other hand, for devices that are likely to be involved in serious incidents, the manufacturer may decide to register as soon as possible to make uploading incidents easier. This may be helped further by assigning a UDI to the device. If the device is likely to be placed on the market after the 18 or 24 months of article 123(3)(e) have expired, this could be treated similar to the second scenario.
  2. The device will be certified under the Regulations at a later date and remain on the European market longer; in this case, the manufacturer may consider registering in Eudamed as soon as possible, and even assigning a UDI. The pseudo-Basic UDI-DI will be different from the MDR/IVDR-related Basic UDI-DI, as well as for the lowest-level UDI-DI. But higher-level UDIs that appear on the labels do not have to be changed. Only their links in Eudamed will change as a result of the new certificates. The UDI on the labels can remain the same. In order to make sure there is a clear break from certificates related to the current Directives to those of the Regulations, it is more efficient if manufacturers choose to let Eudamed create DI and ID data for legacy devices. Once their devices are certified under the Regulations, they can copy the datasets to the new Basic UDI-DI and UDI-DI and link these to the current UDI on their labels.

Of course, other strategies may be used. The bottom line is that during the transitional period for Eudamed, devices involved in serious incidents or field safety corrective actions will be registered in Eudamed.

Additional Eudamed and European medical device regulatory resources:

  • European CE Marking strategy for medical device companies
  • European MDR gap assessment and transition consulting
  • Webinar: Eudamed requirements under the EU MDR and IVDR
  • Whitepaper: The role of Eudamed in Europe

AUTHOR

  • Ronald Boumans