Match the registration evidence to the operator role
The European Commission confirms mandatory use of four EUDAMED modules from 28 May 2026: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. The last module serves competent authorities and the Commission. The remaining modules have their own implementation status. A supply-chain checklist should preserve those distinctions. Module commencement and the applicable transitional deadline for uploading a particular device are separate questions. Article 123 retains transitional provisions that must be checked for the device; the module start alone does not establish that every previously placed unit needs a new upload that day. 1 5
The MDR assigns actor-registration duties to specified roles. Article 31 addresses manufacturers, authorised representatives and importers. Article 30(2) allows Member States to maintain or introduce national provisions for registration of distributors. That division explains why a distributor's national evidence and an importer's EUDAMED evidence answer different questions. 1
A supplier can therefore have a valid reason for providing a national distributor registration instead of its own importer SRN. The buyer first needs to establish whether that supplier is acting only as distributor for the units under review. Conversely, an SRN belonging to another operator leaves open who performed the importer duties in this transaction.
The operational error is to turn an onboarding field into a universal requirement. A form headed "supplier SRN" should have a role-specific answer path. If the supplier is a distributor, collect the upstream manufacturer and, where applicable, importer details along with national-registration evidence. If the supplier is the importer, collect evidence appropriate to that role. Article 13 and Article 14 remain the underlying sources for the respective checks. 1 2
Registration also has a limited evidentiary role. An actor record identifies an operator in a registered role; it supplies no independent demonstration of probe compatibility, OEM authorization, repair quality or clinical performance. Procurement needs those questions answered by the corresponding technical or contractual evidence.
Classify the transaction before asking for the number
MDCG 2021-27 Rev.1 explains the importer/distributor distinction through the first making available of an individual device on the Union market. A transfer of ownership, possession or another property right may matter, and the role can arise before physical handover. The guidance also distinguishes logistics activities and describes several supply arrangements. It is nonbinding guidance supporting practical implementation of the MDR. 2
For ultrasound inventory, a model-level classification is often too coarse. Two units of the same probe model can arrive through different contractual chains. A company can be importer for one group and distributor for another. Keep the unit or batch traceability that lets a reviewer connect the actual supply history to the role assessment.
| Illustrative sourcing arrangement | Role question to resolve | Evidence that makes the answer usable |
|---|---|---|
| EU dealer acquires a device from a non-EU supplier for its first making available on the Union market | Which EU-established person places that individual device on the market? | Contracts and supply history; manufacturer, authorised representative and importer identification; relevant Article 13 records |
| EU dealer buys a unit already placed on the Union market by an upstream EU importer | Is the dealer making that unit available as distributor? | Upstream supply and importer details; relevant Article 14 checks; national-registration assessment |
| EU-established manufacturer ships from a factory outside the EU to an EU dealer | Who is the legal manufacturer and who first makes the unit available? | Manufacturer identity and the contractual chain; factory geography alone is insufficient |
| Logistics provider stores or dispatches devices for another operator | Does it acquire the rights and perform the activity that creates an importer or distributor role? | Defined service agreement and actual activities; identify the responsible economic operator separately |
| A unit returns after export, repair or prior use | What was the unit's earlier market status, and what activity occurred while away? | Serial history, prior placement or putting-into-service evidence, service scope and any modification assessment |
These are editorial applications of MDR definitions and MDCG examples. Apply them to the actual contractual and supply history of the shipment, warehouse activity or repair return. 1 2
The last row deserves particular care. A probe arriving from a third country might be a newly supplied unit, a previously marketed device returning after service, or a substantially altered device requiring a different assessment. A shipping label captures its latest journey. It leaves much of that regulatory history unstated. Retain the serial record and prior supply evidence before treating re-entry as a fresh first placement.
Similarly, a loaner agreement needs review of the actual commercial activity and supply chain. The MDCG guidance discusses leasing arrangements, but a generic label such as "loaner" settles neither operator role nor all applicable obligations. The fact that a device is supplied without payment also fails to settle the question: the MDR definition of making available expressly includes supply free of charge in the course of a commercial activity. 1 2
Keep verification duties separate from a physical-inspection slogan
Before selecting those checks, record whether the unit is MDR-conforming, an eligible legacy device under Article 120, or stock already lawfully placed on the market. Establish the declaration/certificate basis, applicable transition conditions and prior-placement evidence rather than inferring status from the model's age. MDCG Question 15 explains that Articles 13 and 14 apply to legacy devices with relevant adaptations; select the labeling and UDI checks applicable to that status. A unit's subsequent availability and its first placement are different events. This gate determines which evidence checklist applies. 1 2
Article 13(2) lists importer verification duties. Article 14(2) lists distributor verification duties and allows a representative sampling method for the checks specified in points (a), (b) and (d). The importer-information check in point (c) requires its own treatment. 1
MDCG Question 18 explains how physical checks, documents, EUDAMED information and contact with relevant operators can support verification. It treats physical checks as an important tool, while expressly recognizing exceptional, justified cases in which physical verification of importer information for every device is unreasonable, for example where opening packaging would compromise its integrity. In those cases, the guidance describes documentary checks. It also says subcontracting operational activities leaves the responsible operator's legal obligations in place. 2
A procedure stating only "inspect 100%" can therefore obscure two different issues: whether the required verification has been completed and what method supplies adequate evidence. A procedure stating only "sample the stock" has the opposite weakness: it may extend sampling to a check for which Article 14 gives no such general permission.
For a packaged probe or accessory, a useful record names the check, evidence and method. If the importer details appear on accompanying documentation, preserve evidence that the documentation reaches the user as required. If the procedure uses a justified documentary method, record the reason, the documents examined and who approved the method. Keep the packaging condition and traceability visible in the same record.
These controls are Rongtao's proposed way to organize the evidence. They supply no universal acceptance threshold, test method or permission to open sterile packaging. The product's instructions, intended use and applicable quality procedures remain relevant to the actual activity.
Belgium and France require different national follow-through
The two national authorities provide a practical comparison of the shared MDR role framework and local registration routes.
| Question | Belgium: FAMHP | France: ANSM |
|---|---|---|
| Does a distributor register in EUDAMED in that role? | FAMHP explicitly says distributors must not register there | ANSM explains distributors have no registration obligation or technical registration role there |
| What national route must be checked? | Distributor registration through the FAMHP web portal under the cited Belgian decree | ANSM Question 3.1 identifies wholesale distributors operating without sales to the public for the national activity declaration; check the procedure’s territorial and activity scope |
| How is importer actor registration handled after 28 May 2026? | FAMHP identifies EUDAMED as the authentic actor-data source and explains portal synchronization | ANSM identifies importer actor registration and the manufacturer's-linking requirement in its EUDAMED FAQ |
| Is ordinary distributor registration enough for relabeling or repackaging? | The authority describes additional Article 16-related notification and certificate handling | Review Article 16 activity and the applicable French process separately from the distributor's ordinary status |
Comparison of the authorities' published guidance, checked 17 October 2026. Belgium's registration page was updated 23 September 2026; the French FAQ was updated 4 June 2026. Other national obligations and activity exemptions require a separate check. 3 4
The practical lesson is to maintain a country-and-activity record alongside the EU role assessment. A supplier may sell across borders, perform more than one activity and use different upstream sourcing channels. Its EUDAMED evidence can answer the actor-registration question while the destination authority's process answers a separate national question.
For a procurement team onboarding a distributor, request the claimed national registration or an explained basis for its inapplicability, together with the upstream role information. Avoid presuming that every French distributor uses an identical declaration route or that a Belgian portal record transfers to another Member State. The scope should be checked against the actual activity and territory. 1 3 4
Assess translation, packaging and repair on their own facts
Article 16 distinguishes activities that cause an operator to assume manufacturer obligations from specified translation and repackaging activities that meet its conditions. Its own-branding provision includes a contractual exception where the manufacturer is identified on the label and remains responsible. Its modification provision turns on whether conformity may be affected. Those conditions should survive any shortened onboarding checklist. 1
Article 16(2)'s specified translation and repackaging activities must be necessary to market the device in the relevant Member State and must preserve its original condition. For sterile devices, opening, damaging or otherwise adversely affecting packaging necessary to maintain sterility is presumed to affect the original condition. The operator also needs the identification, quality-system and certification arrangements in Article 16(3)–(4). 1
At least 28 days before making the relabeled or repackaged device available, the importer or distributor informs both the manufacturer and the competent authority of the destination Member State. A sample or mock-up goes to those recipients upon request. Within that same advance period, the operator submits the relevant notified-body quality-system certificate to the competent authority. Notification, a requested sample and certificate submission are distinct obligations. Record fulfillment of each condition alongside the relevant portal evidence. 1 3
Article 23 addresses parts and components. Paragraph (1) concerns making available an item specifically intended to replace an identical or similar integral part to maintain or restore function without changing performance, safety or intended purpose, and it requires supporting evidence. Paragraph (2) addresses an item that significantly changes performance, safety or intended purpose and treats that item as a device in its own right. This is a parts-and-components provision, rather than a blanket classification of every repair service. 1
An ultrasound service enquiry should therefore describe what is being supplied and changed. A replacement cable, an altered acoustic component and an unchanged probe returned after diagnosis present different facts. Generic categories such as "restorative repair" or "rebuild" are too broad to substitute for the technical assessment and applicable conformity route.
Rongtao recommends collecting the model and serial identification, the requested work, the original specifications and the supporting service evidence before quotation. OEM names identify the equipment involved. They establish no OEM authorization or endorsement of the service provider.
Method and limits
This report synthesizes MDR definitions and Articles 13, 14, 16, 23, 30 and 31; MDCG 2021-27 Rev.1; the Commission's current EUDAMED implementation overview; and the published Belgian and French authority guidance. It uses transaction examples to connect those sources to ultrasound procurement. The examples are hypothetical and establish no prevalence rate or observed supplier behavior. 1 2 3 4 5
An EUDAMED actor snapshot is unsuitable for measuring how many distributors comply with national rules, because distributor-only registration falls outside that actor system. Likewise, broad trade, tender or manufacturer counts provide no proof that a particular probe is imported, compatible, compliant or safe. Those counts have been excluded from the decision tool.
The comparison covers Belgium and France. Switzerland and other Member States require separate national analysis. The article supplies an evidence-organizing method for qualified commercial and regulatory teams; it gives no repair instructions or device-specific conformity decision.
For the next supplier intake, select one actual unit and complete its supply chain, claimed role, registration route, verification record and proposed service scope. If a supplier's role changes between those fields, resolve the transaction facts before reusing its credentials for the rest of the inventory. That single-unit check gives a distributor or service buyer a concrete basis for a better document request.