EU Ultrasound Replacement Parts: Article 23 and EUDAMED in 2026

Which Article 23 sentence applies to the part?

Article 23 splits the shipment in two sentences. Paragraph 1 keeps a supporting-evidence file. Paragraph 2 says the significant-change item shall be considered a device.

Article 23, checked in the MDR consolidation of 19 July 2026, provides two routes:

Under paragraph 1, the item must be specifically intended to replace an identical or similar integral part or component that is defective or worn, restoring or maintaining function while preserving performance, safety characteristics and intended purpose. The person making it available must ensure that it avoids adverse effects on the device’s safety and performance and retain supporting evidence for Member State competent authorities. Paragraph 2 treats a replacement that significantly changes performance, safety characteristics or intended purpose as a device subject to the Regulation. ¹

Both sentences are conditions on the item and on the purpose for which it is made available. Neither names an ultrasound board, a probe, a cover or a gel. A catalogue title, a 510(k) number or a register row leaves the sentence unchosen. The file has to state the purpose of this shipment.

Article 2(27) defines making available as any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether for payment or free of charge. ¹ Paragraph 1 then adds its own conditions: an identical or similar integral part or component, defective or worn, replaced so as to maintain or restore function, without a change to performance, to safety characteristics, or to intended purpose. A file that speaks to only two of those three characteristics has left the sentence unfinished. Where the stack is met, the person who makes the item available shall ensure it does not adversely affect the safety and performance of the device, and shall keep supporting evidence available for the competent authorities. For an item correctly qualified solely as such a part, this provision imposes the supporting-evidence duty rather than a standalone Article 29 device-registration duty. Qualification as a device or accessory in its own right must be assessed separately.

Paragraph 2 keeps the replacement purpose and changes the effect. The item significantly changes performance, or safety characteristics, or intended purpose. It "shall be considered to be a device" and shall meet the Regulation. From there, the device rules apply, including the manufacturer's registration duty where the placing conditions are met. Identify the manufacturer separately under Article 2(30). Article 2(30) gives that title to a person who manufactures or fully refurbishes a device, or has a device designed, manufactured or fully refurbished, and markets it under that person's name or trademark. ¹ On a paragraph 2 shipment the buyer asks who that person is.

Accessories remain within the MDR device framework

Article 2(2) defines an accessory through the manufacturer’s intended use with one or several particular medical devices, enabling their intended use or specifically and directly assisting their medical functionality. Article 1(4) then groups medical devices and their accessories under the term “devices” for the Regulation. Annex VIII, section 3.2, provides for accessories to be classified in their own right, separately from the device with which they are used. ¹

This matters for gels, covers, patches, software and other products used around an ultrasound system. Their actual intended purpose, claims, configuration and applicable qualification govern the route. Accessories remain regulated within that collective term. Nor does using a finished, separately regulated probe to replace a broken probe automatically strip away the probe’s device status. A product-level regulatory assessment is required before relying on Article 23(1).

COCIR’s 2024 maintenance guideline connects the statutory boundary to service practice: appropriately experienced personnel, spare parts meeting the manufacturer’s specifications, and a technical service report that records the work and relevant part identifiers. It is industry guidance rather than legislation. The following evidence workflow uses that guidance to make the statutory duty actionable; its suggested file format is Rongtao’s synthesis. ⁵

Apply the right EUDAMED date to the right device

Commission Decision (EU) 2025/2371, published on 27 November 2025, confirmed the functionality of actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. The Commission subsequently stated that mandatory use begins on 28 May 2026. These four modules are distinct from the vigilance module. ^{6 2}

Article 123(3), as amended by Regulation (EU) 2024/1860, sets the six-month module-application period and the twelve-month device-entry transition. The Commission’s device-and-certificate graphic translates those provisions into the practical dates below. Its Q&A explains how the first unit and further units under a device identifier are treated. The Q&A’s older hypothetical July notice is an illustration of that structure; use the actual published timetable for the live rollout. ^{7 3 4}

The manufacturer should confirm the legal and identifier basis for a legacy-device transition. Legacy entries may use an EUDAMED ID rather than a UDI-DI. A list consisting only of catalogue names is too coarse for this decision. The Q&A explains that the registration covers units sharing the same device identifier even when their production identifiers, such as serial or lot numbers, differ. ⁴

A procurement team can use an internal completion date comfortably before 28 November. That date falls on a Saturday, but this article proposes no later deadline based on a separate weekend calculation. Follow the Commission’s published date and obtain case-specific regulatory advice if a disputed deadline computation would affect a transaction. Choosing an earlier operational date allows time to correct identifier mismatches, incomplete actor information or a rejected data submission.

As of this review, the functionality decision covers the four systems listed above. It provides no basis for treating vigilance as part of that same mandatory-use notice. Existing safety-reporting duties continue through the applicable routes. A manufacturer should check current module availability and reporting instructions when a safety action arises, rather than interpreting “not yet in this rollout” as “no reporting.” ^{6 4}

A finished probe introduced in September under a new UDI-DI illustrates why the distinction matters. Its first-placing route calls for registration before that first unit. A continuing product whose first unit was placed before 28 May may instead fall within the transition described above. The calendar belongs to the product identifier and placing history; a purchase order’s date alone provides only one part of that history.

Who enters the device?

For devices, including applicable accessories and Article 23(2) replacements, Article 29 places the device-entry duty on the manufacturer. Importers, distributors and service providers then need to understand their own separate responsibilities.

Before placing a device other than a custom-made device, the manufacturer assigns a Basic UDI-DI and provides it to the UDI database with the other core data elements in Annex VI, Part B. Before placing, the manufacturer also enters or verifies in Eudamed the information in Section 2 of Part A of Annex VI, except Section 2.2, and keeps it updated. ¹ Article 27(3) requires assignment of a UDI before placing, and submission of the Part B information to the UDI database before placing, again with the custom-made device outside the first duty and the investigational device outside the database submission. ¹ Annex VI, Part C, calls the Basic UDI-DI the primary identifier of a device model, the main key in the UDI database, and the identifier referenced in relevant certificates and EU declarations of conformity. ¹ The Q&A's registration unit is the UDI-DI. A Basic UDI-DI without the UDI-DI of the unit about to be placed leaves the twelve-month question on the wrong identifier.

The Q&A exempts distributors from EUDAMED actor registration while noting that national distributor registration may still apply in the Member State where they make devices available. ⁴ Article 30(2) allows Member States to maintain or introduce national registration rules for distributors of devices made available on their territory. ¹ Those national rules were not checked country by country. The Q&A sentence is about an Eudamed actor account. It leaves the manufacturer's Article 29 duty where it is, and it sits in a document that says it is not formally endorsed. ⁴

Articles 13 and 14 set out importer and distributor checks for devices. Importers verify the applicable conformity elements and device registration and add their details as required. Distributors verify CE marking, the declaration of conformity, required manufacturer information, importer particulars and applicable UDI assignment. Apply those device duties to products correctly qualified as devices or accessories. For a qualifying Article 23(1)-only component, document the qualification and supporting-evidence basis; an unsupported assertion that the item is “just a part” is insufficient. ¹

MDCG 2021-27 Rev. 1, December 2023, explains the roles for an individual device. Its disclaimer identifies it as non-binding MDCG guidance and reserves binding interpretations to the Court of Justice. ⁸ Its role guidance must be combined with a separate product qualification.

Within that limit the guidance is concrete, and it applies when the item is a device. Placing refers to each individual device. An EU person who obtains that device from a third-country operator and is first to place it is its importer. A person who sources it from a Union importer, distributor or manufacturer and supplies it onward is a distributor. An EU distributor who buys it directly from a non-EU manufacturer or distributor, and places it, becomes the importer. Several importers may place one model. Several importers of one individual device are outside this guidance. ⁸ Onward supply of a device an EU importer has already placed is the Q&A's distributor case. First placing of a unit obtained from outside the Union is the importer case, and Article 13(4) then asks for a check of the manufacturer's Article 29 registration.

Separate ordinary repair from a new or fully refurbished device

Full refurbishment has a specific MDR meaning. Article 2(31) concerns complete rebuilding of a device already placed or put into service, or making a new device from used devices, to bring it into conformity, combined with assigning a new lifetime. Under Article 2(30), the party that manufactures or fully refurbishes, or has this done, and markets the device under its name or trademark is the manufacturer. Those conditions are more specific than the commercial word “refurbished.” ¹

The Commission’s 2022 Blue Guide, section 2.1, also distinguishes ordinary repairs from changes that produce a new product. It explains that repaired products which remain outside the new-product category need no repeat conformity assessment solely because of the repair, including where temporarily exported for repair. This is horizontal interpretive guidance; the MDR’s particular rules, the actual changes and national requirements still govern the medical-device case. ⁹

For an unchanged repair-and-return of the customer’s already-placed scanner, retain its identity, service history, work scope and assessment of the changes. Evaluate the exchanged component separately under Article 23 and complete qualified acceptance before clinical return. A new lifetime, changed intended purpose or substantial rebuild needs a fresh regulatory assessment. The label on the service invoice should reflect the work performed rather than deciding its legal effect.

Software-bearing replacements deserve particular care. A board revision may depend on firmware, licensed functions and a particular system configuration. A physically compatible connector provides little evidence about those dependencies. Identify the actual software and hardware combination and assess its effect against the established device specifications. The sources provide no universal percentage, channel-count threshold or version-number rule for “significantly.” Escalate unresolved changes to the responsible technical and regulatory personnel before committing to the route.

What a register row can show

A clearance record identifies the submitted product in its own jurisdiction. Reading its exact name can expose a mistaken assumption about what a broad product code contains.

The FDA classification and clearance data provide a useful caution about search vocabulary, rather than an EU qualification tool. Four ultrasound-related codes are shown below. Their counts come from an independently recounted 2 October 2026 snapshot; they are submission rows, not installed devices, European registrations or replacement shipments. ¹⁰

The openFDA 510(k) snapshot of 2 October 2026 contains 176,223 rows. On every row of the four codes below, the openFDA regulation number and device name are filled. ¹⁰ The code classifies the device in the submission. It is silent on the Article 23 purpose of a later shipment.

ITX is the diagnostic-transducer code, and the same code holds other names. Of 414 ITX device-name strings, 172 contain "transducer" or "probe" and 242 contain neither. Device name is free text. These are vocabulary counts; product types require record-level assessment. ¹⁰

Named rows show both sides. Olympus probes UM-3R and UM-G20-29R are K250883, 18 September 2025. Olympus probes UM-S20-17S and UM-S20-20R are K250762, 11 July 2025. FUJIFILM endoscopic probes P2612S-L and P2620S-L are K231666, 13 December 2023. Vitrolife's "Ultrasound Transducer Cover" is K241662, 30 August 2024. Global Protection's "Natural Rubber Latex Ultrasound Transducer Probe Covers" is K213087, 7 June 2022. EM-TECH's "Passive Ultrasound Probe Strap" is K254143, 10 August 2026. The ready file also places "APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM" in ITX as K072826, 24 October 2007, applicant stored as "Toshiba America Medical Systems, In.C". ¹⁰ These are substantially equivalent decisions in the ready file. The summary PDFs were not opened. Applicant names identify the record.

IYN is a system code on the same file. GE's Versana Active, K191798, 9 August 2019, carries IYN, regulation 892.1550, and the pulsed-Doppler imaging-system name. ¹⁰ That scanner record supplies neither a separate clearance for an internal board nor the supporting evidence for a later replacement shipment.

The board search failed, and that failure is the result. Across the device names in the same snapshot, the strings "pcb", "pcba", "circuit card", "circuit board" and "printed circuit" returned one hit: K030141, product code DTQ, regulation 870.4220, "MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100", Cardiovention, Inc., 26 February 2003. The hit is a model name on a heart-lung console. A spare-word scan surfaced K864508, a hip system, and K800670 and K800671, replacement reagents. None is an ultrasound spare board. ¹⁰ Device name is free text. The device-name field describes the submission and provides no complete inventory of its internal parts. The miss establishes the limit of that exact name search. It leaves board registration status and the Article 23 evidence duty unresolved.

The usable finding is narrower than a catalogue classification: names and product codes can identify records worth opening, but the record must be connected to the actual product, intended purpose and jurisdiction. A US clearance establishes neither EU compliance nor an Article 23(1) exemption. A separately regulated probe retains its applicable device obligations when sold as a replacement unless a defensible product-specific assessment supports a different qualification.

Six shipment decisions to document before dispatch

These examples are hypothetical applications of the reviewed texts, not rulings on a particular OEM product. Each starts with a different product and transaction description. They are useful for exposing missing evidence before a quotation becomes a shipment commitment.

An integral board supplied to restore the scanner’s function

The proposed replacement is an identical or similar integral board for a scanner whose original board is defective or worn. The documented purpose is restoring function while preserving performance, safety characteristics and intended purpose. If those facts and the product qualification substantiate Article 23(1), the supplier keeps evidence that the replacement avoids adverse effects on safety and performance. ¹

Request the system model, board manufacturer part number, revision, identifiable markings, proposed software configuration and the reason replacement is needed. Ask which specifications and tests support the supplier’s claim for that configuration. The relevant evidence may combine a part-level inspection with qualified testing in the intended system. A general statement that a board powers on leaves important questions about its intended use unresolved.

A standalone device-registration request is then a different question from the Article 23 supporting-evidence request. The supplier may hold an SRN for another role or product; that number identifies an actor and says little about this board’s suitability. Keep the product qualification and technical evidence tied to the exact supplied item.

A finished probe supplied as a device or accessory

Start from the probe manufacturer’s intended purpose, labelling and EU documentation. When supplied as a device or accessory in its own right, it remains within the applicable MDR device framework. Replacing the customer’s broken probe is the commercial reason for purchase, not an automatic route out of that framework. ¹

Request the exact UDI-DI or relevant legacy identifier, Basic UDI-DI where applicable, manufacturer and authorised representative details, conformity documents and registration evidence. Establish whether the first unit under that identifier was placed before or after 28 May 2026. The first-placing and transition paths then follow the date table. US probe clearances in the dataset are illustrations of product identity, not substitutes for this EU file.

If a supplier proposes treating an integral probe component solely as an Article 23(1) replacement, ask for a reasoned qualification specific to that component and configuration. Avoid deciding from the broad words “probe,” “transducer” or “spare.” The acceptance plan should address the exact probe type and applicable OEM instructions, including cleaning and disinfection compatibility where relevant.

A replacement intended to significantly change the device

A board, front end or software-bearing assembly proposed to significantly change performance, safety characteristics or intended purpose falls into Article 23(2). The replacement is treated as a device and must meet the Regulation. Registration is only one part of that obligation: determine the responsible manufacturer and applicable conformity assessment, technical documentation, labelling and post-market duties. ¹

Stop the routine replacement workflow while that assessment is unresolved. A promise of additional functions or different clinical use may be evidence of a changed purpose, even when the physical installation resembles an ordinary repair. Review the promised outcome together with the technical change. A supplier’s claim that the assembly is compatible is insufficient to resolve the conformity route.

The same principle applies to a software licence change associated with hardware. Record the resulting functions and intended configuration. Technical staff should identify the change, and the responsible regulatory function should determine the implications. Neither a general repair certificate nor an actor-registration number establishes compliance for the changed device.

A cover, gel or patch supplied in its own right

Read the manufacturer’s intended purpose and regulatory documentation for the exact product. If it is a medical-device accessory, Article 1(4) keeps it within the collective MDR device framework; classification is assessed separately from the ultrasound system. If it qualifies as a medical device itself, apply that route. A generic product outside those definitions requires a different analysis. ¹

The data illustrate why terminology is a weak shortcut. The ITX clearance category includes named ultrasound covers and a probe strap as well as probes. The category name alone therefore cannot tell a buyer what the carton contains. The supplied documentation, model and intended purpose must match.

A purchasing description should specify the product reference, packaging, intended use, sterile status where relevant, and the actual conformity and registration basis. A registration belonging to another manufacturer’s superficially similar gel or cover gives no assurance about this product. Retain the identity connection from label to documentation to invoice.

A completely rebuilt scanner with a new lifetime

Assess the actual rebuild against the MDR definition of full refurbishment. If the activity meets that definition and the rebuilt device is marketed under the responsible party’s name or trademark, that party falls within the manufacturer definition. The device then needs the applicable conformity and registration pathway. ¹

Ask which entity assumes manufacturer responsibility, what new lifetime is assigned, how conformity has been demonstrated and how the device is identified. A parts list and a successful functional test address only portions of this evidence. A commercial warranty period and a newly assigned device lifetime are distinct concepts and should be recorded separately.

A seller using “refurbished” to describe cleaning, inspection and limited repair may be describing a different activity. Obtain the work scope rather than assuming that the same marketing word always produces the same MDR outcome. Where the documentation and claims conflict, resolve the discrepancy before purchase.

The customer’s existing scanner is repaired and returned

Document the original device identity, evidence of its previous placing or service, and the repair scope. For an ordinary repair that leaves it outside the new-product category, the Blue Guide supports treating it as a repair rather than requiring repeat conformity assessment solely because of that work. A temporary trip outside the Union for repair does not by itself change that conclusion. ⁹

The actual changes still matter. Review the replacement component under Article 23, check whether the activity constitutes full refurbishment or another manufacturer-triggering change, and preserve the technical service report. Customs treatment and national rules may require additional advice; this article resolves neither customs valuation nor a country’s specific operator obligations.

Clinical return is a separate acceptance decision. Qualified personnel should perform the tests appropriate to the system, intervention and applicable instructions. A return shipping label or a completed database lookup is no substitute for that acceptance.

Build an evidence packet that follows the supplied item

Article 23(1) specifies an outcome and an evidence-retention duty, rather than a prescribed universal form. The following packet is a practical implementation proposal based on that duty and COCIR’s maintenance guidance. Its scope should be proportionate to the component, device and repair. ^{1 5}

A useful evidence record is specific enough to retrieve later. “Tested” should point to a dated test record and a stated scope. “Compatible” should identify the system and configuration for which the conclusion was reached. “Same part” should be reconciled with the markings and revision actually supplied. These are operational review questions, not a claim that Article 23 mandates each field by name.

Keep uncertainty visible. When a donor history is incomplete, record the limitation rather than converting an unknown into a clean provenance statement. When a test covers only a board’s basic operation, describe that scope accurately. When final system acceptance belongs to the customer’s engineering team, state the handoff and required information before dispatch.

For a device or accessory route, add a second layer covering EU conformity and registration. Match the label’s manufacturer and product identity to the declaration of conformity and relevant certificate where required. Confirm the exact identifier used in EUDAMED and whether the entry describes a Regulation or legacy device. An actor SRN identifies an economic operator; a Basic UDI-DI groups the model; a UDI-DI identifies the device at the registration level. Keep those functions distinct. ^{1 4}

Annex VI contains the underlying data requirements. Rather than asking the service supplier to invent every field, obtain the responsible manufacturer’s controlled information and reconcile the purchasing identity to it. Packaging quantity, production-identifier structure, risk class, manufacturer details, intended labelling and relevant warnings are among the information the manufacturer manages. Optional or inapplicable fields should follow the actual annex and product circumstances, not a procurement template that marks everything mandatory. ¹

A transition claim also needs evidence. Ask when the first unit under the relevant identifier was placed, whether further units will be placed, and which registration route the manufacturer is using. A dated manufacturer statement and identifiable entry or completion plan can make the basis reviewable. The level of assurance required for a particular transaction should be decided by the responsible operator, with advice where needed.

For a distributor managing several purchase lines, review each line against the same five questions: what is the supplied item, which regulatory route supports it, who is the responsible manufacturer or parts supplier, what is its placing history, and which evidence is still missing? Assign the open question to a named person. A mixed shipment can include an Article 23(1) component, a finished accessory and a repaired customer-owned device; a single blanket declaration for the whole carton can conceal those differences.

Keep the commercial and regulatory timelines connected. A supplier’s expected dispatch date should leave enough time for the importer’s applicable checks, identification corrections and facility acceptance planning. Where a registration transition legitimately applies, document that basis rather than assuming that every missing database entry is a breach. Conversely, where first registration is required before placing, an intended future entry is an open requirement. The review result should describe the actual unresolved issue and its owner so that procurement can make an informed decision about the affected line.

Where Rongtao fits and what the buyer should send

Rongtao’s parts catalogue and service capabilities provide routes for part identification, sourcing and repair enquiries. The quality process can help a buyer understand the available technical evidence. OEM names identify equipment; they do not imply OEM authorisation or an OEM-issued regulatory determination.

For a case-specific enquiry, send the OEM and system model, manufacturer part number, revision and label photographs, fault symptoms or error behaviour, quantity, destination country and proposed transaction. Include the intended hardware/software configuration if known. Provide images only through safe handling by qualified personnel; this article gives no instruction to open or work on energised equipment.

For probes, use the probe-repair service route and identify the probe type, observed defect and relevant cleaning-state information. Follow the exact OEM instructions and facility policy for handling and decontamination. Keep patient information out of photographs and logs shared for a quote.

Ask the supplier which records and tests it can provide for that exact item. Availability, repair feasibility, delivery terms and warranty need case-specific confirmation. The manufacturer and relevant EU economic operators retain their regulatory responsibilities; a repair quotation is not a conformity assessment or competent-authority decision. Use the contact page to agree the technical handoff before shipment.

Method and limits

The legal crosswalk was reviewed against the MDR consolidation dated 19 July 2026, the 2024/1860 amendment, the 2025/2371 functionality decision, the Commission’s rollout announcement and transition materials, and the 2022 Blue Guide. Consolidated text is a documentation aid; the authentic acts remain the Official Journal versions. The Commission Q&A and MDCG guidance are interpretive aids with their stated non-binding limitations. ^{1 7 6 4 8 9}

The openFDA snapshot contained 176,223 submission rows. An independent recount reproduced ITX 414, IYN 1,183, IYO 894 and JOP 72. Among ITX device-name strings, 172 contained “transducer” or “probe” and 242 contained neither. The board-name search used the phrases pcb, pcba, circuit card, circuit board and printed circuit with word boundaries. Its single hit was the unrelated console model described above. These are exact-query results on a dated snapshot, with free-text naming and submission-level limitations. They measure neither EU compliance nor the replacement-parts market. ¹⁰

The article offers no finding about a named supplier’s compliance, a particular board’s legal status or a device’s fitness for clinical use. Its contribution is the connected review sequence: qualify the supplied item, identify the responsible actor, establish placing history, apply the correct registration timing, and retain the technical evidence supporting the repair or supply decision.