EUDAMED & Regulation (EU) 2024/1860: Your basis for compliance and market success
The European Database for Medical Devices (EUDAMED) is a central component of the EU regulations MDR (2017/745) and IVDR (2017/746). It aims to increase the transparency, traceability and safety of medical devices and in-vitro diagnostics (IVDs). The new Regulation (EU) 2024/1860 significantly expands the regulatory framework for the use of EUDAMED, making the requirements for manufacturers, importers and other economic operators clearer and more binding. But what do these changes mean for companies in practice? How can companies implement these requirements efficiently and in good time? What new processes and systems are necessary to fulfil the regulatory requirements? This article provides a comprehensive overview of the key aspects of Regulation (EU) 2024/1860 and shows what you need to consider when successfully integrating EUDAMED into your company processes.
In an increasingly digitalised and data-driven world, the structured management of information is essential. Especially in the regulated medical device sector, reliable systems are needed to efficiently organise and securely provide data such as product information, economic operator registrations, certificates and vigilance reports. This is an important aspect for the fulfilment of regulatory requirements and effective market surveillance, which should also significantly facilitate communication and cooperation for authorities and stakeholders.
To ensure this at European level, EUDAMED has been developed, a central database that harmonises and standardises the exchange of information between all parties involved. It brings together information on products, manufacturers, notified bodies and regulatory processes and supports more effective market surveillance.
Regulation (EU) 2024/1860: Gradual introduction of EUDAMED to harmonise MDR and IVDR requirements!
In order to accelerate the introduction of EUDAMED and create clearer, more binding guidelines for its use, Regulation (EU) 2024/1860 was adopted. It supplements the existing requirements of the regulations on medical devices (MDR, EU 2017/745) and in vitro diagnostic medical devices (IVDR, EU 2017/746) and now regulates the gradual activation of the six EUDAMED modules. The aim is to overcome the fragmentation in national registration processes and establish a harmonised European standard.
The modular introduction reduces the risk of delays and enables a more pragmatic implementation. This gives manufacturers and other economic operators the opportunity to start important registration and monitoring processes at an early stage in order to fulfil the compliance requirements of the MDR and IVDR in good time. The regulation also aims to increase both the transparency and traceability of medical devices and diagnostics. At the same time, it ensures increased efficiency for the cooperation of economic players, which in the long term contributes to strengthening competitiveness in international comparison.
The central modules of EUDAMED!
As already mentioned, the EUDAMED database is made up of six modules, which will gradually become mandatory:
- Actor module (ACT module): This module has already been available since December 2020. It enables manufacturers, importers, authorized representatives and procedure pack producer to register in the database and obtain a Single Registration Number (SRN). This registration is necessary to be able to use the other EUDAMED modules.
- UDI/Device Module (UDI/DEV Module): The UDI/Device Module enables the unique identification and registration of devices via the assignment of a UDI-DI. Voluntary use from functional release, mandatory six months later. 12-month transition period for “legacy devices”.
- Notified Bodies & Certificate Module (NB / CRF module): This module is responsible for the registration of certificates issued by notified bodies. Notified Bodies must register all relevant certificates within 18 months of confirmation of functionality.
- Vigilance & Post-Market Surveillance module (VGL module): This module relates to vigilance notifications and market surveillance and becomes mandatory six months after publication of the functional release. This contributes to improved traceability and effective risk management.
- Market Surveillance module (MSU module): This module is only accessible to competent authorities and ensures that all necessary data for market surveillance is available. This enables effective monitoring of products on the market.
- Clinical Investigations/Performance Studies module (CI/PS module): This module is required for clinical studies and becomes mandatory six months after confirmation of functionality. It supports the regulatory monitoring of clinical studies and performance evaluations.
Deadlines and obligations to act!
In contrast to Regulation (EU) 2017/745 and Regulation (EU) 2017/746, Regulation (EU) 2024/1860 now introduces the mandatory use of EUDAMED modules in stages. Once a module has been declared functional, manufacturers, importers and other economic operators must fulfil the corresponding requirements within six months. For example, all actors involved in the measure in EUDAMED must register and already use the Actor Module to obtain a Single Registration Number (SRN).
The development of the UDI/DEV module is well advanced, and a notification of full functionality is expected in spring 2025.
Economic operators should be prepared for the UDI/DEV module. However, until compliance with EUDAMED is achieved, economic operators must observe the product notification of the national requirements. Please contact us if you have any questions.
The NB/CRF and MSU modules are only to be maintained by Notified Bodies or the competent authorities. No entries by manufacturers, importers or other economic operators are required here.
The new MDCG 2024-22 (Gradual roll out of EUDAMED Gradual roll out of EUDAMED ) provides answers to many questions.
Risks and opportunities of the introduction of EUDAMED!
The implementation of the new requirements presents both challenges and opportunities for manufacturers, importers and other economic operators. The biggest challenge lies in timely registration and comprehensive data management, especially during the transition phase in which national and EU-wide regulations are applied in parallel. This can lead to double registrations and an increased administrative burden.
Clarification of double registrations: During the transition phase, it will be essential for companies to fulfil both national and EU-wide requirements, which may lead to an increased administrative burden. However, well-structured planning and the early use of internal SOPs can help to make this dual registration as efficient as possible. Some nations are already relying on EUDAMED. Contact us and we will help you to avoid double registrations.
TentaConsult - your partner for compliance and market success!
Regulation (EU) 2024/1860 and the gradual introduction of EUDAMED are bringing about changes for the medical device industry. Companies that react to the new requirements at an early stage minimise regulatory risks and create valuable compliance.
Our team of experts will support you in meeting these challenges - from strategic planning to operational implementation. We offer customised solutions to ensure your compliance.
Our services at a glance:
- strategic registration: We support you with the voluntary and mandatory registration of your products and stakeholders in EUDAMED. Our experts ensure correct entries and avoid delays to ensure your legal compliance.
- optimise internal processes: We support you in adapting your workflows and updating SOPs so that your processes meet the requirements of Regulation (EU) 2024/1860.
With TentaConsult as your partner, you not only ensure the legally compliant positioning of your products on the market, but also utilise the new regulatory requirements as an opportunity for sustainable market success. Contact us and together we will develop a customised compliance strategy that meets current and future requirements.
