EUDAMED Compliance: What Changes for Importers, Distributors, and Authorized Representatives 

With the May 28, 2026, deadline coming closer the compliance obligations under EUDAMED apply across the full range of economic operators, not just manufacturers. Importers, distributors, and authorized representatives (ARs) each have their own distinct obligations under the MDR (Medical Devices Regulation) and IVDR (In Vitro Diagnostic Regulation). 

What importers and distributors need to verify before handling medical devices 

The legal obligation for importers to carry out conformity checks before placing a device on the EU market already exists. What changes from May 28, 2026, is that the relevant EUDAMED modules become mandatory to use, which means the device registration check must be carried out directly in the system. 

Under Article 13, importers are required to verify that the device is registered in the database and to ensure their own importer details are recorded where required. Importers do not create the manufacturer’s registration record, but they cannot place a device on the market unless they have confirmed that registration is in place. If it isn’t, handling the product may put an importer in breach of their own obligations, independently of the manufacturer’s compliance status. 

Beyond the registration check, importers also need to confirm before placing a device on the market: 

• The manufacturer has appointed an authorized representative where required 
• The device carries a valid CE mark 
• The relevant documentation is in order 

Distributors have their own verification duties under Article 14, but their role is narrower. They are required to check that registration is in place before making a device available, though they are not placing devices on the market themselves and do not carry the same scope of responsibility as importers. In particular, they are not registered in the Actor module of EUDAMED and have no SRN; their access to EUDAMED is limited to the public website. 

The role of Authorized Representatives (AR) in EUDAMED compliance 

For non-EU manufacturers, the AR is the regulatory interface with the EU market. The manufacturer remains the primary actor for device registration in EUDAMED, but the AR is responsible for cooperating on compliance matters and supporting the process, which from May 28 includes making sure the mandatory module submissions are handled accurately. 

The practical risk right now is capacity. An AR without a clear process for supporting EUDAMED submissions can slow down or block market access, and with weeks to the deadline, switching ARs is rarely realistic. The more immediate step is to clarify with your current AR exactly what they can handle and where the manufacturer needs to take direct action. 

For ARs themselves: the primary registration duty sits with the manufacturer, but if you are facilitating or validating submissions on their behalf, ensuring the data is accurate and complete is part of your role, and gaps in that process can create exposure for both parties. 

What non-compliance means for manufacturers, importers, and ARs 

Non-compliance carries penalties for all economic operators, not just manufacturers. Under MDR and IVDR, member states are required to set penalties that are effective, proportionate, and dissuasive. The specific amounts vary by country, but enforcement can extend beyond fines to corrective action orders, suspension of market placement activities, and increased regulatory scrutiny going forward. Importers can face these measures independently of anything applied to the manufacturer. 

Ongoing obligations once you’re registered 

Getting registered is just the beginning. Here’s what the ongoing requirement looks like in practice: 

• Registration is role-specific. A company acting in more than one capacity, such as both an importer and a manufacturer, may need to register separately for each role. 
• Organizational changes must be updated promptly. Any change to company name, address, or the person responsible for regulatory compliance must be reflected in the system within one week. 
• Device data needs to stay current. Registration isn’t static; device information must remain accurate throughout the product’s market lifecycle. 
• More modules are coming. The Vigilance and Clinical Investigations modules are still under development. When the commission declares them functional, they’ll become mandatory without a voluntary use period. Organizations already working within the system will have less catching up to do. The European Commission currently expects the Vigilance Module to become mandatory as early as Q2 2027. 

Plan your EUDAMED compliance roadmap with osapiens 

Knowing the consequences of non-compliance is one thing. Having a structured plan to address them is another. 

The osapiens EUDAMED Compliance Guide is designed to help you bridge that gap. It covers: 

• The core requirements of the database, including the obligations for economic operators and the role of UDI and device registration 
• How to efficiently prepare your organization for data submission and navigate the registration process 
• How digital solutions can simplify compliance, reduce manual effort, and keep data accurate and consistent across systems 

Download the guide and build a compliance plan that’s grounded in what the regulation actually requires.