In 2017, the European Commission introduced two novel regulations, one for medical devices (MDR) and the other for in vitro diagnostic (IVDR). The primary objective of the MDR and IVDR regulations is to enhance transparency and streamline the coordination of data on medical devices available in the EU market. These regulations emphasize the establishment of a comprehensive and versatile database known as the European Database for Medical Devices (EUDAMED).
The EUDAMED system integrates six modules to collate and process the information on medical devices and manufacturers:
- Actors Registration
- Unique Device Identification (UDI) and Device Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-Market Surveillance
- Market Surveillance
Currently, EUDAMED is not mandatory, causing significant confusion within the medical device industry regarding the specific actions and timelines manufacturers must follow to meet the EUDAMED requirements outlined in the EU MDR and IVDR regulations. The mandatory use of the system will start six months after the EUDAMED system (including all six modules) has been declared fully functional following an independent audit, and the publication of a Commission notice in the Official Journal of the European Union.
EUDAMED registration deadline is Q2 2026, but waiting until then is risky. Once EUDAMED is fully functional in Q4 2024, reporting serious incidents becomes mandatory, requiring device data to be in EUDAMED and reported within days. The manufacturer’s EUDAMED requirements involve data collation, data preparation and validation, and post-upload management.
The IVD deadline, which is likely November 26, 2023, as per the IVDR requirement for devices to be entered into EUDAMED 18 months after the IVDR application date. Although the devices module is functioning well, the status of EUDAMED’s full functionality remains uncertain, which could lead to changes.
Let’s delve into the main aspects of EUDAMED and its significance.
Key Objectives of EUDAMED:
- Transparency and Traceability: EUDAMED provides public access to information on medical devices, including product details, clinical investigations, certificates, and manufacturers’ details. It ensures transparency for healthcare professionals, patients, and regulatory authorities, allowing informed decision-making and traceability throughout the supply chain.
- Improved Market Surveillance: By centralizing data related to medical devices, EUDAMED enables regulatory authorities to perform robust market surveillance. It facilitates monitoring adverse events, performance evaluations, and vigilance reporting, contributing to the early detection of potential risks and the enforcement of corrective actions.
- Streamlined Registration and Reporting: EUDAMED simplifies the registration process for economic operators, such as manufacturers, authorized representatives, importers, and notified bodies. It establishes a standardized data entry, submission, and maintenance platform, minimizing administrative burdens and ensuring compliance with EU regulatory requirements.
The Six Modules of EUDAMED:
- Actors Registration: The process by which economic operators, such as manufacturers, authorized representatives, importers, distributors, and notified bodies, register their organization and relevant information within the EUDAMED database. By registering in EUDAMED, economic operators provide information that enables regulatory authorities, healthcare professionals, and other stakeholders to verify compliance with the applicable regulations.
- Unique Device Identification (UDI): This consists of Basic UDI (BUDI-DI) and Unique Device Identifiers (UDI-DI). The Basic UDI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics. UDI-DI Consists of a unique numeric or alphanumeric code assigned to each medical device. It includes various elements, such as the device identifier, which identifies the specific model, version, and manufacturer, and the production identifier, which provides information like the lot number, serial number, and expiration date.
- Notified Bodies and Certificates: EUDAMED houses information about certificates issued by notified bodies; Independent organizations designated by EU member states to assess conformity with regulatory requirements.
- Clinical Investigations and Performance Studies: Clinical investigations involve evaluating medical devices through studies conducted on human subjects. These studies assess the device’s safety, performance, and any potential adverse effects or risks associated with its use. In EUDAMED, information regarding clinical investigations is stored and managed, including study protocols, results, reports, and other relevant data.
On the other hand, performance studies focus on assessing medical devices’ performance characteristics and reliability. These studies test the device’s functionality, accuracy, precision, and other performance parameters. The data collected from performance studies help determine the device’s effectiveness and reliability in delivering the intended clinical outcomes.
- Vigilance and Post-Market Surveillance: EUDAMED is a central repository for vigilance and post-market surveillance data. It enables the reporting and analysis of adverse events, field safety corrective actions, and other post-market surveillance activities.
- Market surveillance: Contributes to the overall goal of ensuring the safety and performance of medical devices in the EU market. It facilitates the efficient exchange of information among regulatory authorities, notified bodies, economic operators, and other stakeholders involved in overseeing and regulating medical devices. By monitoring and evaluating the compliance and safety of medical devices, market surveillance activities help maintain patient safety, strengthen public trust, and ensure the continuous improvement of medical devices available in the EU market.
How EUDAMED Affects You
If you’re a medical device manufacturer, authorized representative, importer, distributor, or healthcare professional operating in the EU, EUDAMED will significantly impact your regulatory processes. Compliance with EUDAMED requirements is crucial to maintaining market access and ensuring the safety and effectiveness of medical devices.
Fang Consulting Can Help
Understanding EUDAMED and Unique Device Identification (UDI) and Device Registration can be complex. If you need assistance navigating EUDAMED compliance or understanding its impact on your organization, Fang Consulting can provide expert guidance and support tailored to your needs.
The European Commission has provided the following guidance on EUDAMED