Gradual roll-out of EUDAMED

When to expect the first modules of EUDAMED to become mandatory  

By Annette van Raamsdonk

After several meetings, consultations and a draft version, the final version of the Questions and Answers (Q&A) on EUDAMED was published a few weeks ago, in November. The Q&A document is a guidance document giving practical information on the new requirements, which followed Amendment (EU) 2024/1860, which we have previously informed you about. In this blog, we will give you some of the highlights from the Q&A document, covering 20 questions.

What is amended and why?

Article 34 MDR is amended to support certain modules of EUDAMED so they can become live and mandatory, while other modules might not be ready yet. Initially, EUDAMED would only become mandatory once all modules are ready.

As a reminder, EUDAMED contains six modules of which three currently are already live (bolded), and optional to be used by manufacturers, Notified Bodies (NB), EU Authorized Representatives (EU AR) and importers.

1. Actor module (ACT module)
2. UDI/Device module (UDI/DEV module)
3. Notified bodies and certificates module (NB/CRF module)
4. Market surveillance module (MSU module)
5. Post-market surveillance and Vigilance module (VGL module)
6. Clinical investigations/performance studies module (CI/PS module)

Article 120(8) MDR and Article 110(8) IVDR are deleted by the amendment, and Article 123(3)(d) MDR and Article 113(3)(e) IVDR are rephrased. In short this means that all obligations linked to a certain module will become mandatory, six months after this particular module is published in the Official Journal of the European Union (OJEU). 

The Actor module (ACT module)

One of the first modules to become live was the ACT Module, allowing amongst other manufacturers, EU ARs and Importers to register themselves and obtain a Single Registration Number (SRN) to get access to EUDAMED. This module is expected to be published in Q1 2025 and become mandatory six months after publication. Currently, the module is already live, and we at Emergo by UL strongly recommend manufacturers to register.

The UDI/Device module (UDI/DEVICE Module)

Currently, manufacturers, or their EU AR, are still allowed to register their devices in local databases to meet registration requirements. However, it is already possible to register devices in the UDI/DEV module, which will make local registrations no longer required in most cases. The option to still use local databases becomes void, six months after the UDI/DEV module is published in the OJEU. All devices, with the exception of custom-made devices, investigational devices and devices for performance studies, will need to be registered in this module. This module is also expected to be published in the OJEU in 2025. There are several options here based on which you will or will not be required to register your device;

The device is placed on the market on or after the date the UDI/DEV module becomes mandatory

In this case, the first individual device, unit, or Article 22 MDR System/Procedure Pack (SPP) placed on the EU market, is required to be registered in the UDI/DEV module. The device registration should take place before placing the device on the market. This initial device registration covers all individual units being placed on the market with the same UDI-DI.

The device was placed on the market before the date the UDI/DEV module became mandatory

If an individual device, unit or SPP with a certain UDI-DI was placed on the market prior to the UDI/DEV Module becoming mandatory, and the additional (sales) units belonging to the same UDI-DI are placed on the market on or after that date, the manufacturer will have 12 months’ time  after the publication of mandatory use in the OJEU, to register the device/SPP in the UDI/DEV.

It is important to note, that if the devices according to the above do not need to be registered and will not be placed on the market 12 months after the publication in the OJEU, the registration requirement may change. This will happen for example in the event of a vigilance case, occurring 12 months after the publication in the OJEU, to one of the devices placed on the market before the UDI/DEV module becomes mandatory.

The notified bodies and certificates module (NB/CRF module)

Certificates issued after this module to become mandatory must be registered by NBs in this module. The requirement to register the certificates lays with the NB. Also updates and decisions to MDR and IVDR certificates, issued after the mandatory use of the NB/CRF module must be registered in the NB/CRF module. Whether or not these certificates had been issued prior or after the mandatory use of the NB/CRF module.

MDR and IVDR certificates issued before the mandatory use of the NB/CRF module have to be registered within 18 months after the publication of this module in the OJEU, if these devices are also still required to be or are registered in the UDI/DEV module.

In addition to certificates, updates and decisions, the obligation for NBs to upload the Summary of safety and (clinical) performance (SS(C)P) in accordance with Articles 32(1) MDR and 29(1) IVDR apply from the moment when the related certificate is registered in EUDAMED.

The Post-Market Surveillance and Vigilance Module (MSU module) and Clinical investigations/performance studies module (CI/PS module)

These modules are still under development and can only be used once released. Currently, the national processes as explained in MDCG 2021-1 Rev. 1 and MDCG 2022-12 is still to be followed for compliance with MDR/IVDR vigilance provisions.

Obligations requirements related to clinical investigations and performance studies, as well as sponsors registration in the actors module become applicable 6 months after the publication in the OJEU of the CI/PS module.

While we provided links to guidance documents, the OJEU and EUDMAED, we imagine more support is needed. So, do not hesitate to reach out to us at Emergo. We will keep you informed about any publications in the OJEU that make certain modules mandatory.