Dive Brief:

• The European Commission has vowed to deploy the first module of the Eudamed medical device database by the start of December.

• In a position paper this week, the Medical Device Coordination Group confirmed the Commission is ready to move ahead with the Eudamed module ahead of its earlier March 2021 deadline.

• With the go-live date now on the horizon, MDCG is “strongly” encouraging manufacturers and other organizations to use the module to obtain a single registration number or SRN.

Dive Insight:

The Commission delayed the introduction of Eudamed by two years last October amid concerns the system would not be ready in time for the original May 2020 target. The database is meant to monitor safety and effectiveness of medical device as part of the now-delayed Medical Device Regulation.

In March, MDCG and the Commission agreed to make the six modules that make up Eudamed available on a rolling basis as they become available.

At that time, the Commission predicted the actor registration module would be ready by March 2021, with modules on device registration and certificates and notified bodies to follow in May. Part of that plan changed recently.

The Commission quietly disclosed plans to bring forward the launch of the actor registration module late last month in an update to its Eudamed page. MDCG confirmed the change in its position paper: “the Commission has confirmed its readiness to deploy the actor registration module as of 1 December 2020.”

MDCG is now preparing the industry for the introduction of the module, which will enable device manufacturers, authorized representatives, importers and system/procedure pack producers to acquire the SRN they need for certificates. 

With almost 18 months between the introduction of the module and the full Eudamed launch, the organizations now have more time to get the SRN they need to use other features of the database. At one point, before the delays to Eudamed and MDR, member states faced the prospect of trying to validate all registration applications in two months.

MDCG is strongly encouraging all organizations to use the module and associated SRN. Recognizing the risk that could create double registration requirements, MDCG set out its take on the regulatory implications of an SRN. 

“Actors that obtain an SRN should be considered in compliance with the actor registration requirements ... to the extent that national laws accommodate for this. In such cases, those actors should follow the obligations and requirements of the MDR related to both the registration of relevant actors (via the actor registration module) and the use of their SRN as required,” MDCG wrote.

The launch of the actor registration module is set to be the first in a series of steps toward the full introduction of Eudamed. Two more modules are set to go live by May as the Commission works toward its goal of having a system ready to audit in time to bring the database online in 2022. In anticipation of the introduction, The Commission last month released a fact sheet detailing the Eudamed information that will be publicly accessible.