May 3, 2021

EUDAMED3 Update: Two More Eudamed Modules Will Be Available Later This Year & Guidance on Alternatives Until the Remaining Three Modules are Released and the Database is Fully Functional

Author: Suzanne Broussard, PhD 

By the end of the year, the first three modules will be accessible on the European medical device database, Eudamed3: Actor Registration, Unique Device Identifiers (UDI)/Device Registration, and Notified Bodies Certificates. The use of these modules is voluntary until all six inter-related modules are ready and Eudamed3 is fully functional. The existing Eudamed2 data base is being overhauled to support the Medical Device Regulations (MDR) and In Vitro Device Regulation (IVDR). 

For more information on the transition from EUDAMED2 to EUDAMED3 see our previous post, The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis.

The six EUMDADED modules are: 

  • Actors Registration 
  • UDI/Devices Registration 
  • Notified Bodies and Certificates 
  • Clinical Investigations and Performance Studies 
  • Vigilance and Post-Market Surveillance 
  • Market Surveillance 

The Actor Registration module became active December 1, 2020. The European Commission has officially confirmed that two more modules will be available by September 2021, the UDI/Device registration (second module) and Notified Bodies and Certificates (third module). Three more modules are scheduled to be displayed as soon as they are functional.  

Actor Registration Module 

“The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN).” 

The SRN is required under MDR and IVDR and allows economic actors to be clearly identified throughout the European Union. In addition, submitting information related to the device to Eudamed as well as submitting an application for conformity assessment to a Notified Body require a SRN. 

Under MDR, all medical device actors, including manufacturers, must register in the updated EUDAMED3 database from May 26, 2021. This includes devices with CE marking under both the directives (MDD 93/42/EEC and IVDR 98/97/EC) and newest regulations (MDR 2017/745 and IVDR 2017/746) that are replacing them. Care should be taken not to duplicate registration as it will trigger a duplication check requiring justification. 

Legacy device manufacturers are also required to register in order to facilitate post-market surveillance, conduct field safety corrective actions, and manage adverse events. However, legacy devices requirements are different, and the European Commission provides detailed guidance on how legacy devices will be identified in Eudamed and how their different device identifier will be generated and assigned. 

The European Commission Medical Devices website on Eudamed currently has the following technical documents, videos, and infographic to support registration of all devices.  

Fully Functional Eudamed 

The Medical Device Coordination Group Document (MDCG 2020-15) foresees the launch Eudamed with all six modules fully functional in May 2022. Use of the modules is volunteer until that full launch. However, while actor registration in still volunteer, the members of the MDCG strongly encourage its use by all relevant actors on their territories, including the use of the SRN by actors as stipulated in the MDR (e.g., indicating the SRN on certificates). One reasons it that actor registration is a prerequisite for accessing Eudamed.  

Note that manufacturers still must maintain compliance with MDR and IVDR regulations even though Eudamed is not functional. MDCG provides guidance on how manufacturers can accomplish compliance. 

Exchange of Information Until Eudamend3 is Launched 

MDCG endorses a guidance document that “describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.” This guidance addressed cases in which the exchange of information would be difficult, or even not possible, based on the corresponding provisions in MDD and Active Implantable Medical Devices (AIMDD).  

MDCG 2021-1 
Guidance on harmonized administrative practices and alternative technical solutions until Eudamed is fully functional 

The MDCG 2021-1 guidance document provides helpful tables that cross reference different articles within MDR and provide guidance on how to meet these requirements in the absence of a fully functional Eudamed. Indeed, 28 pages of the 31-page document presents a table that clearly notes within the article which actor is responsible for what type of information exchange. Previsions related to the use of Eudamed (as referred to in Art. 123(3)(d) MDR) are side by side with the alternative solutions to submit and/or exchange information (as required under the MDR).  

One solution that is referenced throughout MDCG-2021-1 is the use of the European Commission’s collaborative platform the Communication and Information Resource Centre for Administrations, Businesses and Citizens, referred to as CircaBC. This website is used for the distribution and management of information by a variety of sectors. An example is both sponsors and member states using the secure folders in CircaBC for reports and certificates for clinical investigations. It is unclear how the documents will be handled once Eudamed is fully functional. Will everyone need to upload the document to Eudamed?  


Moving Forward 

The deadline for MDR 2017/745 compliance is May 26, 2021, and IVDR 746/2017 compliance is May 25, 2021. 

If your organization needs support getting your technical documents ready for the transition to MDR or IVDR during this ever-changing landscape of medical regulations, Criterion Edge has the expertise and bandwidth to work with you and get the job done. Please reach out to us for a free consult. 

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[WEBINAR] How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions

In this second installment of a 2-part webinar series on Wednesday May 12, 2021 at 11AM PST / 2PM EST, we will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, and help you identify possible gaps for mitigation prior to submission to regulatory authorities.

Attendees are eligible for a free consultation and scan of their CER. Spots are limited – click to register for this free webinar.