EUDAMED-Now or Later?

EUDAMED now or later? UDI/Device registration strategy for manufacturers

With the EUDAMED go-live date rescheduled multiple times, manufacturers face conflicting strategies of when to make UDI/Device registration submissions to EUDAMED. Though a few may ignore the facts and think (hope) that EUDAMED will never happen, the critical question is not Will EUDAMED become mandatory, but When will EUDAMED become mandatory. The following discussion reviews various factors that will help manufacturers form a successful plan for UDI/Device registration taking into consideration the EU EUDAMED Roll-out Amendment adopted 2024-May and published in the Official Journal of the European Union 2024-July.

Background

The European Union Medical Device Regulation (MDR) (2017/745) and In Vitro Diagnostic Regulation (IVDR) (2017/746) established a new regulatory platform identified as the “European Database on Medical Devices” (EUDAMED). This database was originally targeted to go-live on 2020-May-26, but for various reasons has been delayed multiple times. The UDI/Device Module, one of the six EUDAMED modules, started capturing medical device product registration data that was submitted voluntarily from 2021-Oct-04. Numerous manufacturers have completed preparation and made voluntary UDI/Device data submissions into EUDAMED. As of this writing, over 448,000 voluntary device records have been successfully received into the official EUDAMED production environment.

EUDAMED draft roadmap

On 2023-Oct-20 the European Commission (EC) issued a draft EUDAMED Roadmap that showed a mandatory UDI/Device registration Transition Period starting 2027-Q4, continuing 18 months, and ending with a final deadline of 2029-Q2. The late development of the Clinical Investigations / Performance Studies (CI/PS) module causes a lengthy delay of the EC Notice announcing all six modules of EUDAMED are fully functional. With the final registration deadline over five years after the EUDAMED Roadmap publication many manufacturers decided at that time to slow their EUDAMED UDI/Device preparation pace or even place their EUDAMED UDI/Device project on hold.

The draft below appeared on the European Commission website as of 2024-Jul-10. By 2026, the first three modules are expected to be mandatory.

EUDAMED Roll-out Amendment

The adoption of the EUDAMED Roll-out Amendment in 2024-May drastically changed the previous draft EUDAMED Roadmap as the EC is now authorized to require use of individual EUDAMED modules that have been finalized, successfully audited, and declared functional without waiting for all six modules to be “fully functional.” Using this new policy, the EC is expected to significantly advance the mandatory use of parts of EUDAMED including the UDI/Device module. The EUDAMED Roll-out Explanatory Memorandum states “mandatory use of several modules could then start as early as Q4/2025.” The accompanying Press Release has stronger wording indicating “this mandatory registration is expected to take effect as of late 2025.” In addition, the Roll-out Amendment collapses the UDI/Device mandatory registration from an 18-month transition period to be only a 6-month transition period. Referencing the timing changes associated with the EUDAMED Roll-out Amendment, the EUDAMED Roadmap is expected to be revised as below. For charting purposes “late 2025” is interpreted to be 2026-Jan-01.

The following timing changes to the UDI/Device Registration Mandatory Transition Period are noteworthy:

• Mandatory Transition Period starts late 2025-Q4 instead of 2027-Q4 (2 years earlier than previously planned)
• Mandatory Transition Period lasts 6 months instead of 18 months (1 year less than previously planned)
• Mandatory Transition Period deadline is late 2026-Q2 instead of 2029-Q2 (3 years earlier than previously planned)

Two EUDAMED UDI registration timing strategies

The earlier EUDAMED mandatory registration timelines enabled by the EUDAMED Roll-out Amendment forces many manufacturers to rethink their UDI/Device registration strategy. There are two groups of responses:

• Later (Hold Off/Stop) – this group includes the ultimate procrastinators and those that believe 1) the registration deadline will be delayed, 2) they can start preparation very late and rush it through, or 3) there is no penalty or risk of being late and out of compliance
• Now (Start/Continue) – this group understands the large preparation and submission effort required for EUDAMED UDI/Device registration. In consideration of their current status, outstanding workload, and the tighter compliance deadlines, these manufacturers decide to initiate, continue, or perhaps accelerate their EUDAMED UDI/Device registration activities.

The case against delaying EUDAMED registration

The Later Registration Strategy has some merit for some manufacturers with only a few records when the Compliance Date is a long time in the future, e.g., five years, but now with a looming Compliance Date of 2026-Jan-01, this position no longer holds merit. The following comments regarding the Later Registration Strategy reveal underlying faults with this approach.

EUDAMED registration delay

One of the main reasons that the EUDAMED Roll-out Amendment was requested by Member States and endorsed/proposed by the EC was to advance the UDI/Device module mandatory period, not to delay it. Note that three EUDAMED modules, Actor, UDI/Device, and Certificate/Notified Body, have been operating on a voluntary production basis from 2021-Oct-04. Since then, the UDI/Device Module has accumulated over 448,000 official production records. Considering the EC resolve to mandate an earlier compliance date, the legal provision now available, and evidence of long-term operation of the target EUDAMED production modules, there appears to be a small probability the UDI/Device registration mandatory Compliance Date of 2026-Jan-01 will be delayed.

Start preparation late and rush it

Based on many use cases, this last-minute blitz approach rarely has good outcomes. Most often the outcome is poor quality data submissions with multiple errors, i.e., not correct, not current, and not comprehensive, that result in multiple submission attempts and rejects. Looking back, most companies reflect that the UDI/Device preparation and registration submission took longer than expected. With excessive submission churn and a larger unexpected workload many manufacturers incur additional costs in overtime pay and/or expensive emergency third-party assistance to meet the compliance deadlines.

No penalty for being late

A non-compliant manufacturer may not be detected immediately, but when identified the MDR/IVDR does have penalty provisions for not implementing a timely compliant regulatory approach. Regulatory violations may result in penalties, lost customer confidence, poor reputation in the market, etc. all of which detract from a positive position in the marketplace.

Why manufacturers should start EUDAMED registration now

The following objectives supported by the Now Registration Strategy benefit the manufacturer and strengthen their overall compliance position.

1. Meet advanced compliance deadlines: The accelerated start date of 2026-Jan-01 and shortened mandatory submission period of 6 months increases the need to move forward and complete EUDAMED UDI/Device preparation and registrations.
2. Maintain momentum: It is more efficient and productive to continue the preparation process as that decision avoids losing team focus, avoids the cost of restarting the activity, and avoids the possible loss of trained staff during a pause in activity.
3. Avoid resource overload: Timely completion of EUDAMED preparation allows internal resources to be available and focus on complying with numerous imminent global Health Authority UDI deadlines, e.g., Australia, Switzerland…
4. Satisfy early EUDAMED and MDR/IVDR adopters: Some EU Member States already recommend use of the voluntary EUDAMED UDI/Device registration module. It is expected that many customers would favor a MDR/IVDR compliant and registered device over an outdated Directive device in making purchasing decisions.
5. Manage complex UDI dataset: The product information required to be reported to EUDAMED poses multiple challenges for manufacturers and incurs significant effort to capture/manage.
   • The UDI dataset includes 111 attributes per device, roughly twice the U.S. FDA count
   • The registration has multiple Device Types, e.g., Legacy Devices, Medical Devices, In Vitro Diagnostics, Systems/Procedures Packs, each with custom business rules
   • The dataset is organized in a two-tier structure: Basic UDI-DI (group) and UDI-DI (device)
   • The dataset has unique EU identifiers: SRN (Single Registration Number for an organization), EMDN (European Medical Device Nomenclature for device type), etc.
6. Process high volume of devices: For those manufacturers that have a medium to high number of device records that must be collected, validated, and submitted to EUDAMED, an early start date helps ensure the workload is processed on time.
7. Develop complex M2M integration: Manufacturers implementing automated machine-to-machine data transfers, e.g., APIs, from their internal repository to a third-party data management/submitter vendor need additional time and effort to develop the data interface.
8. Decrease risk: Without an early UDI/Device registration plan, there is a significant risk of failing to meet the mandatory submission period. Non-compliance may result in EC and/or EU Member State intervention with possible impacts in loss of product shipments, loss of revenue, and patient loss of necessary device products.
9. Meet registration prerequisite for vigilance reporting: Early UDI/Device registration enables Serious Incident Reports to be submitted quickly within the 2-, 10-, and 15-day requirements.
10. Meet compliance retention requirements: Early UDI/Device registration facilitates device record maintenance and retention requirements for 10 years (and 15 years for implants) after the product is no longer placed on the market.

Recommended plan for EUDAMED UDI/Device compliance

The recommended plan is discussed in the context of a manufacturer engaging a third-party vendor, in this case LexisNexis Life Sciences, to assist in the UDI/Device data management and registration to EUDAMED.

Complement your internal regulatory resources

LexisNexis Life Sciences offers the following capabilities:

• Extensive Medical Device UDI Expertise and Experience
• Professional Services: Subject Matter Experts, Support, Training, Data Management…
• Robust, Flexible, Global Data Management Platform that is Regulatory Compliant

Good practices

• Think globally
• Engage LexisNexis Life Sciences early and start preparation of infrastructure and UDI/Device data
• Engage LexisNexis Life Sciences for a multi-year term to ensure a continuous, uniform approach that allows you to achieve the objectives in the Now Registration Strategy

Steps to comply with EUDAMED UDI/Device registration requirements

1. Collect/cleanse UDI data: most effort, longest time; start as early as possible; comply with Basic UDI-DI creation deadline
2. Submit UDI data to Playground: most development is done; test/validate submission pathway; check data against EUDAMED rules

• Submit early to production: comply with recommendations for early EUDAMED Actor and UDI Reporting by EU Competent Authorities (e.g., France ANSM, Ireland HPRA), Healthcare Industry (customers), or other Health Authorities outside EU.

Key takeaways for EUDAMED UDI/Device compliance

Don’t procrastinate – use time wisely to collect, cleanse, test, and report high-quality UDI data; the process typically takes longer than expected.

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