What should “we’ll handle EUDAMED” mean in writing?
It should identify the entities, devices, activities, and ongoing responsibilities included in the service. Ask whether the agreement covers actor registration, identifier review, data preparation, entry, correction, and maintenance. A broad assurance is a starting point for clarification, rather than evidence that each task is complete.
The MDR and IVDR distinguish manufacturer and Authorised Representative responsibilities. Have a qualified professional assess the relevant mandate and obligations. This checklist concerns project clarity; it does not rewrite the legal relationship or replace review of the agreement.
Which actor record should you ask to see?
Ask for the manufacturer’s own actor record and SRN, along with confirmation of the current representative relationship. The AR’s SRN identifies the AR, rather than replacing the manufacturer’s identifier. The Commission’s Actor registration page explains the separate actor registration process.
Check the exact legal name and address against the relevant product documentation. If the group has several subsidiaries or brands, identify which legal manufacturer the review covers. A record under a familiar group name may be relevant, but its presence alone does not resolve the identity of the actor responsible for your devices.
If the request is still pending, ask for the request status, outstanding actions, and the person responsible for responding. Keep authority assessment separate from tasks the AR or manufacturer can complete directly. Do not convert an estimated timeline into a promise of approval.
How should you define the portfolio boundary?
Use a device inventory with identifiers and regulatory routes, rather than a statement such as “all current products.” Agree which models, variants, and relevant records are included. Note any exclusions and the reason they need separate assessment or work.
The Commission’s UDI/Device resources provide distinct datasets and legacy guidance. A mixed portfolio may need more than one preparation route. Ask who decides the correct route and who confirms the corresponding identifiers before entry begins.
Have both parties review the same inventory version. If sales add a new model after scope is agreed, the team should know whether that model joins the current project or a separate release process. A dated boundary makes changes manageable and reduces uncertainty at handover.
What evidence distinguishes preparation from completion?
Ask what was prepared, what was submitted, which records reached the expected state, and which exceptions remain. A source spreadsheet, XML file, submission acknowledgement, and searchable public record answer different questions. Preserve the link between them instead of treating them as interchangeable proof.
For a public check, ask for the date, search name or identifier, and observation. An unsuccessful search should be described as “not found under these search conditions,” rather than an accusation. Confirm the underlying record and search choices before deciding what the observation means for the company.
For project completion, request a reconciliation against the agreed portfolio. This is a practical acceptance recommendation, not a new statutory filing. It lets the manufacturer understand whether the promised scope was delivered and which unresolved questions need professional review.
Who approves the data before submission?
Identify the source-data owner, regulatory reviewer, authorized submitter, and person who accepts the completed work. The same individual may hold several project roles, but each decision should remain explicit. Technical ability to enter a field is different from authority to decide its correct content.
Ask how grouping, classification, and identifier questions are escalated. Keep decisions with their evidence so an operator does not have to infer a regulatory answer from a partially completed file. Read Basic UDI-DI explained if the disagreement concerns which devices belong together.
Establish how corrections reach the source system as well as the submitted output. A one-off correction made only in the database can leave the next export inconsistent. The project should have a controlled way to keep reviewed source data and current records aligned.
Who handles changes after the initial project?
Clarify whether maintenance is included, what triggers it, and what your team must provide. New devices, corrected attributes, and changes in business relationships can create additional work. The initial scope should not be assumed to cover every future change without checking the agreement.
Ask who watches for a change requiring action and who confirms that the update was completed. Agree a route for urgent questions as well as routine maintenance. These are service-design questions whose answers should be documented, rather than assumed from the existence of an AR mandate.
Confirm access continuity. Your organization should know the authorized internal contact and the process for changing providers or users. Avoid making future records dependent on access credentials informally shared by someone who no longer has the appropriate role.
How should deadlines be discussed with the AR?
Separate the device transition, new-device registration, and certificate-record work. Mandatory use began on . The Commission’s transition materials distinguish the later device and certificate milestones; a later certificate transition is not a general extension of device-registration timing.
The legacy device registration deadline is , as confirmed by the Commission’s devices and certificates timeline. Ask your adviser to state which rule applies to each part of the portfolio, and read the deadline guide.
What if the assurance and the records do not match?
Raise a specific evidence question and allow the provider to explain the difference. Search naming, portfolio boundaries, recent work, or unresolved corrections may explain the observation. Begin with the facts available rather than a public accusation about the provider or manufacturer.
Send the legal company name, identifiers, date checked, and the expected record. Ask for the corresponding evidence and the next action if a gap is confirmed. Keep the discussion tied to the agreed scope so both sides can distinguish a delivery question from a new requirement.
Request a free check if you need a dated public-record starting point. Request an independent specialist introduction if professional review or additional capacity is needed. EUDAMED Compliance does not act as an AR, decide your compliance status, or guarantee another provider’s work.