EUDAMED is one of the key elements of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The European Database for Medical Devices, or EUDAMED, is intended to store and provide information on the manufacture, distribution, certification, and post-market surveillance of devices.

Many adjustments took place because of the effect of the COVID pandemic, including the EUDAMED database launch. However, with the major pause, The Commission is in its final stage of development, announcing that EUDAMED is expected to simultaneously launch at the end of 2022 for both Medical Devices and IVDs!

What does this mean for you?

This is a major requirement for Medical Devices and IVDs and means that major changes are just around the corner along with additional registration requirements.

EUDAMED consists of six modules:

  • Actors Registration (available for voluntary use from December 2020 until 26 May 2022)[1]
  • UDI/ Devices Registration (available for voluntary use from October 2021 until Q4 of 2022)[2]
  • Notified Bodies and Certificates (available for voluntary use since October 2021, with the exception of mechanism for scrutiny and clinical evaluation consultation procedure (CECP) functionalities)
  • Clinical Investigation and Performance Studies
  • Vigilance and Post-Market Surveillance
  • Market Surveillance

What to expect in the coming days?

EUDAMED released a timeline (reference Figure 1) with target dates of implementation.

MEDIcept recommends submitting voluntary registrations before the mandatory use is in effect, as there are several requirements following thereafter. This means creating UDI Governance Team, identifying UDI requirements for your products, creating a UDI plan from collected UDI data, and making sure you comply with regulations!

Products must be registered for the subsequent requirements that occur when the EUDAMED notice is released (targeted for 2023).

Q1-Q2 2023 – The database is expected to undergo independent auditing and present the results to the Medical Devices Coordination Group (MDCG).

Once all six modules go live during Q4 of 2023, there will be progressive mandatory enforcement of the use of all modules, expected to follow through until Q2 of 2025.

Figure 1 – Target Dates of Implementation

[1] Voluntary use means that since Dec. 2020, manufacturers and economic operators can obtain a Single Registration Number (SRN) and register on a voluntary basis in the database. However, after 26 May 2022, when the complete database is planned to be ready, member states can call for Actor Registration on a national basis under Regulation (EU) 2017/745 on medical devices (MDR).

[2] 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.

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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.

For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.