Ensure regulatory compliance with expert support in EUDAMED registration, UDI traceability, and effective economic operator management
Economic Operator Management System MDIS
EUDAMED Economic Operators registration support
Implementation of a Medical Device UDI Traceability System
Medical devices are designed, developed, produced and marketed by the manufacturer. The manufacturer may depend on multiple parties in the logistic chain (Economic Operators) when entering a market, for example:
Manufacturers may further decide to work with distributors to make their devices available further in local markets. Economic operators other than the manufacturer may further perform regulated actions, such as repackaging and relabeling medical devices.
For each of the economic operators, specific regulatory requirements may exist. Such requirements vary from registration in regulatory databases such as EUDAMED for economic operators under MDR or the FDA establishment licence database.
Once registered, parties will need to fulfil regulatory requirements, which may go as far as the need to implement a Quality Management System to ensure activities conform with the regulations, including relevant traceability requirements per the Basic UDI, UDI-DI and the UDI-PI.
In addition, the EU MDR economic operators bear the responsibility to fulfil tasks to ensure that the products they handle conform to the European legislative requirements.
At MedQAIR we have developed a system to support economic operators, for which we refer to our MDIS website.
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Find answers to common questions about our services, compliance processes, and how we can assist your business.
An economic operator is any organization involved in placing a medical device on the market or making it available within a jurisdiction. This may include manufacturers, Authorized Representatives, importers, distributors, UK Responsible Persons, and US Agents, depending on the applicable regulatory framework.
Digital healthcare solutions, and especially Artificial Intelligenc
The SRN is a unique identifier issued through EUDAMED that allows economic operators to be recognized across the European regulatory system. It is often required during conformity assessment and regulatory interactions.
e-enabled medical devices (AI/ML-enabled medical devices) require extensive post-market surveillance activities. These technologies can have a direct, but more often an indirect impact on the health and safety of human beings. Implementation of robust post-market surveillance and post-market monitoring systems is crucial to detect abnormal behaviour, which may have several causes, such as but not limited to performance drift. Similarly, it is important to monitor the security of products after they have been released onto the market.
This applies not only to medical devices and in vitro medical devices, but also applies to Artificial Intelligence systems. Similarly, all other digital products are subject in Europe to the Cyber Resilience Act (2024/2847).
Other services we can support companies with are their EUDAMED registration process, continued Management System improvement processes (e.g., audits, due diligence activities, interim PRRC and DPO roles, etc).
Importers must verify that devices meet applicable regulatory requirements before placing them on the EU market. They are also responsible for maintaining records, supporting traceability, and cooperating with competent authorities when necessary.
Distributors are responsible for ensuring that devices are handled, stored, and transported in accordance with regulatory requirements. They also play a role in traceability, complaint handling, and post-market activities.
UDI traceability helps identify and track medical devices throughout their lifecycle. Economic operators may need to manage Basic UDI-DI, UDI-DI, and UDI-PI information to support compliance, post-market surveillance, recalls, and supply chain transparency.
Depending on their role and responsibilities, economic operators may need documented procedures or a formal Quality Management System to support regulatory compliance, traceability, complaint handling, and operational controls.
EUDAMED serves as a centralized European database that facilitates registration, device identification, vigilance reporting, market surveillance, and regulatory transparency across the medical device ecosystem.
Documentation requirements may include registration records, traceability information, declarations of conformity, complaint records, distribution records, and evidence demonstrating compliance with applicable regulations.
Economic operators may be required to participate in complaint handling, field safety corrective actions, vigilance reporting, and communication with manufacturers and competent authorities regarding device performance and safety issues.
Common challenges include EUDAMED registration complexity, maintaining UDI traceability, managing documentation, meeting regional regulatory requirements, and coordinating responsibilities across multiple markets and stakeholders.
Regulatory software can support EUDAMED registration activities, UDI management, document control, audit readiness, compliance tracking, and workflow automation. This helps reduce manual effort while improving visibility and control.
MedQAIR provides regulatory support for economic operator registration, EUDAMED activities, UDI traceability implementation, compliance process management, and the MDIS platform to help organizations manage their regulatory obligations efficiently.
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