The European Databank on Medical Devices (Eudamed) will go live from the 25 March 2020. This database is essential to the functioning of the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR)— which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively. Compliance with the Eudamed database requirements under the MDR and IVDR will therefore be key to receiving the necessary MDR certification.
The Eudamed is a database that incorporates information on economic operators, devices, UDI, certificates, clinical studies and performance studies, vigilance data and market surveillance into a single, globally assessible platform. It has been designed to continually monitor the safety and performance of medical devices, enabling a streamlined approach for data comparison and providing transparency in the distribution chain.
Eudamed will be internationally accessible to all manufacturers and economic operators in the industry selling products on the European Market, Competent Authorities (CA) and Notified Bodies (NB), as well as some access to the general public.
The European Commission and Medical Device Coordination Group (MDCG) is currently in the midst of processing the designation of NBs, the transition to MDR and IVDR certification and the design and set up of the Eudamed. As such, any delay to the launch of the Eudamed is likely to lead to a delay in MDR certification.
The functional specifications for the Eudamed is currently scheduled for release this quarter. This document will detail the exact data required by its users and the precise function the system and its components perform. However, organisations can get ahead and avoid any potential delays in the release of this document by collecting their data and defining their data collection processes inhouse, using the MDR specifications as a guide. This information is going to be incorporated into the Eudamed to improve safety, efficiency and transparency in the industry.
Early adopters of data collection—that begin developing strong strategies now and start streamlining their data into these projected specifications—will find their businesses better protected and even improved upon during this process.
The timeline.
• Q1 2019: Functional specifications for the Eudamed released.
• Q3/Q4 2019: Audit of the full functionality of the specifications.
• Q1 2020: Audit of Functional specifications finalised.
• Up to 25 March 2020: Eudamed goes live.
To collect your data.
Eudamed will incorporate data from a total of seven separate modules in the industry. From information on operators and devices through to certificates and studies, the Eudamed will require a high level of detailed data. To maximise efficiency, secure your certification and even develop access to data that can further your own business, use the following steps to strategize your data collection:
• Prepare an availability matrix.
• Use the MDR regulation and MDCG guidance documents to create the formats for your data entry.
• Use the experience of the FDA GUDID process as an additional guide.
• Analysis of the availability matrix will identify any missing information.
• Decide on your organization’s method for data entry.
• Train people in data entry or enable an IT system to collect data.
• Update quality procedures.
Start now.
Designing an effective and efficient approach to gathering data takes time. It is far simpler to adjust decisions and, if necessary, modify processes to close any gaps once the functional specifications are released, than designing, testing and implementing a process or system under the pressure of an imminent deadline.
The EU Commission has already confirmed that Eudamed will be modular and use existing components for its system. Organizations should therefore start gathering and streamlining the relevant data now to develop the optimum data collection process for their business.
The Eudamed is scheduled to launch just 2 months before the MDR certification in 2020, so ensuring an organization’s familiarity with data collection will be a vital step in making the transition to MDR and IVDR certification.
Collaborate.
Investigate the ways that similar organizations are preparing their data collection during this transition to MDR certification. MDR forums can be a useful platform to share and discuss processes and could be particularly useful for smaller companies to access.
You can also contact The Tao of Excellence to guide your business during this process. Our team has an international portfolio of specialist advisors that has the expertise and experience—with proven strategies and training programmes—to optimise the performance of your organization at any level. From up-to-date research reports to targeted strategies, our specialists can provide you with the required solutions for your business.
Deepa Rajagopalan
Phone
+41 52 685 51 65
Email
[email protected]
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