What does a US manufacturer need to verify first?
Confirm your legal manufacturer identity, the active EU Authorised Representative relationship, and your own EUDAMED actor record. The representative’s registration is separate from yours. The Commission’s Actor registration guidance states that non-EU manufacturers need an active representative and a mandate summary for actor registration.
Start with the legal entity named on the relevant product documentation. A US parent, subsidiary, brand owner, and commercial exporter may be different entities. Your AR agreement and your manufacturer record should be reviewed against the correct identity, rather than matched only by a familiar brand name.
How are the manufacturer and AR responsibilities different?
The manufacturer and Authorised Representative have distinct roles under the applicable EU regulation. The AR’s written mandate matters, but a service agreement does not automatically transfer the manufacturer’s regulatory responsibility. Check MDR Articles 10 and 11 or the corresponding IVDR provisions with a qualified professional.
For the registration project, make the working split explicit. Identify who confirms actor identity, prepares the mandate summary, approves identifier groups, assembles device attributes, submits records, and resolves questions. These project tasks help implement the relationship; they do not redefine the legal allocation in the regulation or mandate.
A useful written scope separates advice, data preparation, entry, review, and maintenance. If the AR says it will “handle EUDAMED,” ask which of those activities it means and for which exact portfolio. Avoid treating a broad assurance as evidence that every device record has been completed.
Does your importer cover the same role?
Do not assume the importer is also your Authorised Representative. The roles carry different obligations and the actual appointment must be confirmed. A company may perform more than one role, but that does not remove the need to identify its capacity in the relevant relationship.
Map the supply chain using legal entities and activities. Ask who introduces the devices into the EU market, who holds the AR mandate, and who is responsible for the manufacturer data. Where responsibilities are unclear, escalate the facts to a qualified professional rather than resolving them through a database-field guess.
What should you ask your AR to show you?
Ask for your manufacturer actor record and SRN, the representative relationship, and a device-level reconciliation against the portfolio you expected to be covered. Request the date and scope of the check. A public record for the representative alone is not evidence that the manufacturer’s device entries are complete.
Where records cannot be found, verify the search name and identifiers before drawing conclusions. A finding should describe what was searched and observed. It should not declare a breach based only on an unsuccessful public search. Ask for the underlying registration evidence and any outstanding correction or access issues.
Our AR verification checklist offers practical questions for that conversation. Use it as a project review aid; your contract and applicable regulation determine the professional and legal responsibilities.
Which deadline applies to your devices?
Mandatory use of the first four modules began on . Determine the regulatory route, first-placement timing, and whether further units continue to be placed on the market when assessing the device-registration transition. The Commission’s overview and transition materials distinguish the device and certificate milestones.
The legacy device registration deadline is , as shown in the Commission’s devices and certificates timeline. The later transition concerns qualifying earlier MDR/IVDR certificates, rather than a blanket delay for all new certificate records.
If you plan a new EU launch after mandatory use began, do not assume the November transition is a general grace period. Include the applicable registration work in the release plan and have the device-category requirements confirmed. Read the full deadline guide for the legacy device registration deadline and transition scope.
Can you reuse US FDA GUDID data?
Some source product information may be useful in both projects, but GUDID and EUDAMED are separate systems with separate requirements. Do not treat one completed database entry as satisfying the other. Compare the actual fields and identifiers rather than assuming the US export is a ready-to-submit EU file.
Use a shared internal source where it is appropriate, with a separate mapping for each destination. Assign an owner to differences so corrections are deliberate and traceable. A field that looks similar across systems may still have a different permitted value, context, or identifier relationship.
For US-oriented UDI information, you can visit UDIComplianceSolutions.com, a sister property of EUDAMED Compliance. This relationship is disclosed so the link is not mistaken for an independent endorsement. The intake form also lets you indicate whether you need GUDID support.
What should an external provider’s handover include?
Request a clear inventory of the records covered, the source-data version, the outcome of submissions, and unresolved exceptions. Include who will maintain the data and how your team will request corrections. A handover that explains the work is more useful than a single statement that the project is “done.”
Confirm how you will retain access and continuity if the provider changes. The organization should know who can authorize future work and where the reviewed source information lives. Avoid leaving the record structure understandable only to the individual who performed the initial entry.
How can this site help?
We can provide a dated observation of your public actor and device records and help identify the next questions to ask. With the sharing consent you give at submission, we can also share your details with one matched independent EU AR firm, regulatory consultancy, or UDI data specialist so they can respond to your inquiry. We do not act as your representative or deliver your registration.
Request a free check if your starting question is whether the expected public records can be found. Use the qualification form if you already know the support you need. A specialist agrees its own scope and terms directly with you, and we disclose any referral arrangement before introducing your company.