EUDAMED and the UDI and Device Registration module

The UDI and Device Registration module (originally two separate modules within EUDAMED) is one of six. The other modules are:

• Economic Operators (Actor) Registration
• Notified Bodies and Certificates
• Clinical Investigations
• Vigilance and Post-Market Surveillance
• Market Surveillance

As EUDAMED is structured around six interconnected modules, manufacturers need to work towards the development and implementation of policies and procedures that ensure the connectivity and interdependencies of each module are identified and managed. However, this is complicated by the fact that in October 2019 the EC announced that the launch of EUDAMED would be postponed. This was then followed by a delay of the MDR date of application from 26 May 2020 to 26 May 2021 due to the COVID-19 pandemic (there was no change to the IVDR date of application).

The revised EUDAMED launch date coincides with the implementation date of the IVDR, and in October 2020 the EC confirmed that a ‘Minimum Viable Product (MVP)’ approach to EUDAMED is to be implemented and that EUDAMED is to be declared fully functional when the MVP is reached.

MVP overview

• solution that just meets the bare-minimum specifications
• simpler features without losing critical functionalities
• only basic functionalities allowing the actors to fulfil their MDR obligations

Since October 2020 the implementation and functionality of a subset of modules has been the EC’s focus, and a staggered release is now planned with the full launch to be completed by May 2022. At the time of writing, the Economic Operators (Actor) Registration module has been released (December 2020) and it is expected that the UDI and Device Registration and Notified Bodies and Certificates modules will be released in September 2021, with their use identified as voluntary.

The use of EUDAMED and the UDI and Device Registration module is voluntary until the fourth quarter of 2022 (which is when the EC expects EUDAMED to be fully functional). The Regulations do require UDI system compliance upon date of application or before placing an MDR- or IVDR-compliant device on the market for the assignment of the Basic UDI-DI and UDI, but they take a risk-based approach to the label and DM compliance. For MDR Class III and implantable devices, the UDI label compliance date coincides with the date of application.

The EC has also provided several mechanisms to EUDAMED stakeholders for the inputting and downloading of data, and guidance to assess the most cost-efficient mechanism to meet the Regulations.

The different entry points include (see Figure 1):

• user interface: a manual input of data through the application
• XML upload: a semi-automated input, in which data can be uploaded by means of XML files. The XML data must be validated against the provided EUDAMED DTX service and entity model XSDs. Generation of the files can be automated, but the action of uploading (or downloading) them remains manual.
  • NOTE: At the time of writing, testing of the XML upload/download functionality has not yet been possible.
• the DTX machine to machine (M2M) system: this option allows for automatic DTX between an external backend system and EUDAMED backend services (including exchanges in bulk). The end-user enters information in the external system and the data is automatically transmitted to EUDAMED, in XML format and following the same conditions as above, without any human intervention. However, if the frequency and/or volume of transmission remains low, the connection of two systems in a fully automatic way may be too costly considering the many architectural, technological and operational aspects involved (e.g. local application readiness, interoperability, infrastructure, security and support)^[1].

Figure 1: DTX mechanisms

Tactical decisions to make when sending data to Eudamed*

To date, the EC’s Guidelines for Member States on the use of Data Exchange solutions covers only the assessment on data related to three modules: Economic Operators (Actor) Registration, UDI and Device Registration and Notified Bodies and Certificates. They intend to include the Vigilance and Post-Market Surveillance and Clinical Investigations modules at a later stage.

Manufacturers should determine how they intend to submit and manage their data. EUDAMED allows two methods of submission: web interface and HL7 SPL (Health Level Seven Structured Product Labelling). It should be noted that several features of M2M capabilities are not expected to be available at the initial launch of the database, and manufacturers should take this into account with regard to their overall approach and the resources required for compliance.

Manufacturers should source their device data and establish processes to manage and maintain (with identification of data) any attribute changes that would cause a trigger for a new UDI-DI.

In addition, manufacturers should establish a process for the review and approval of data for electronic submissions and the interface between their internal systems (or a third-party provider) and EUDAMED.

Manufacturers should establish communication processes with their notified bodies to coordinate the certificate linking and (when applicable) the SS(C)P, to ensure the completion of device registration. This process is also needed to support communication between the two parties to support certification changes (e.g. amendments and supplements).

This blog is an excerpt from our whitepaper on European Union Medical Device Regulation and In Vitro Device Regulation: unique device identification , please download the full whitepaper to find out more about the UDI System and the EU MDR 2017/745 and IVDR 2017/746 regulations.

Author - Mary Gray, Associate Director EU MDR UDI, Johnson & Johnson