IVDeology are a UK based regulatory and quality compliance support company, with over 100 years combined of expertise within our team, providing you everything you need for your in-vitro diagnostic device life cycle to support you on your compliance journey. In this most recent blog written by Regulatory specialist TszWai Woo takes a look at what EUDAMED is, and what the changes mean to you.
The Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’) introduced the requirement of EUDAMED, the European database on medical devices. It has been over 3 and 2 years, respectively, since the date of application of the MDR and IVDR, and even after several transition extensions and amendments to both regulations, EUDAMED is still a way off from being fully functional.
With another proposed Regulation (2024/0021 (COD)) due to be published in the Official Journal of the European Union, it is worth having a recap on what EUDAMED is, the current status and what changes the new regulation will introduce.
What is EUDAMED?
EUDAMED is a European database on medical devices that the European Commission was to set up, maintain and manage, as required by the MDR and IVDR. The aim of EUDAMED is to improve transparency and provide information on medical devices on the EU market to the public and healthcare professionals. It also aims to improve medical device traceability, enhance coordination between the EU National Competent Authorities and provide them with easy access to relevant regulatory information.
EUDAMED contains information on medical devices which are organised into the following 6 categories, also known as modules:
- Actor registration
- UDI/Devices registration
- Notified Bodies and Certificates (except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities)
- Clinical Investigations and Performance Studies
- Vigilance and post-market surveillance
- Market Surveillance
A lot of the information within EUDAMED is to be accessible to the public via a public website.
Current State of Play
To date, only the following 3 modules have been available for voluntary use:
- Actor registration (since December 2020)
- UDI/Devices registration (since Oct 2021)
- Notified Bodies and Certificates (since Oct 2021)
Therefore, manufacturers can submit their organisation and device details on a voluntary basis.
For Actor registration, as well as providing the organisation details, all manufacturers will need to provide a declaration on information security responsibilities and non-EU manufacturers will also need to provide a mandate summary document.
For UDI/Device registration, manufacturer will need to submit device information such as the Basic UDI-DI & UDI-DI, the European Medical Device Nomenclature (EMDN) and notified body (NB) certificate information (if applicable). For devices requiring NB conformity assessment, the NB must confirm the device information in EUDAMED before the device can be publicly available. Therefore, conformity assessment must be completed before prior to registering a device in EUDAMED.
NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) on voluntary basis. However, there is a caveat: all the parties referenced in the certificates must first be registered, also on a voluntary basis, in EUDAMED.
Additionally, the ‘Vigilance and post-market surveillance’ and ‘Market Surveillance’ modules are due to be made available Q2/2024 and the ‘Clinical Investigations and Performance Studies’ module is not due to be made available before Q3/2026.
EUDAMED was intended to be mandatory for all economic operators to use, after all 6 modules were declared fully functional following an independent audit and a Commission notice was published in the Official Journal of the European Union.
Proposed changes to EUDAMED requirements
Instead of waiting for the completion of the 6th module to make the use of EUDAMED mandatory, 2024/0021 (COD) proposes a gradual roll-out of the mandatory use of each EUDAMED module, once they have been audited and declared functional.
This means that the mandatory use of 3 modules (Actor registration, UDI/Device registration and Notified Bodies & certificates) could therefore start in Q4/2025.
Given the requirements of Article 123 (3) (d) MDR/113 (3) (f) IVDR and Article 123 (3) (e) MDR/113 (3) (a) IVDR, this would mean that mandatory use of all six modules cannot be expected before Q4/2027 and final transitional periods will not end before Q2/2029.
Final Thoughts
Whilst the medical device industry waits with bated breath for the proposed regulation to be published in the Official Journal of the European Union, it is advisable that manufacturers ensure they understand and have all the information they need for the EUDAMED Actor and UDI/Devices registration processes. Hopefully, the proposal will encourage more manufacturers to register on a voluntary basis, as delays in the module development have resulted in low adoption of EUDAMED.
As a UK provider of quality and regulatory services, IVDeology are proud to engage with the IVD industry and keen to support IVD manufacturers with IVD devices market access. For further information on how we can help, please contact [email protected] or you can book straight into our calendar here
Note: This blog contains a summary of the key changes within the proposal, it is important that Manufacturers read and understand the proposal in full, and get independent legal advice if required.