Is a Missing EUDAMED Device Record Still Allowed?

When Is a Missing Device Record Still Permitted in October 2026?

An importer taking in a sterile single-use device in October 2026 can search the public EUDAMED UDI/Devices site by trade name, SRN or device identifier and find no device record.⁹ The useful question is which clock applies to that identifier. A headline that the database became mandatory on 28 May 2026, and a headline that transitional arrangements run into 2027, can both be true of different objects.

Regulation (EU) 2024/1860 lets each completed EUDAMED system become mandatory on its own timetable after the Commission publishes a functionality notice.¹ Commission Decision (EU) 2025/2371, done at Brussels on 26 November 2025, confirms four systems: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. Vigilance and clinical investigations are outside Article 1. The decision enters into force on the day of its publication in the Official Journal.² The Commission states that publication was in the Official Journal of 27 November 2025, and that the four modules are mandatory to use as from 28 May 2026.³

The device-record question is narrower than that module date. Article 1(6)(b) of Regulation (EU) 2024/1860 replaces MDR Article 123(3)(e). Article 1(6)(a) is the amendment of point (d), which is the six-month rule for obligations tied to a functional system. Article 1(3) of the same regulation amends Article 78 on coordinated assessment of clinical investigations. It is not the device-registration amendment.¹

Read on 3 October 2026, a missing device record can still sit inside the 12-month period, can be outside Article 29 altogether, or can be a reason to hold the shipment. The sections below separate those outcomes. This page reads the MDR. The same regulation amends the IVDR on a parallel timetable, and that IVDR calendar is outside this check. The page that assigns the UDI role, and states that a first EU placing after mandatory use needs a record before placing, remains the rule for that first unit: who assigns the UDI, and when a first EU placement needs a record.

Which Device Record Is Still Inside a Window, and Which Shipment Is Not?

Point (d) of Article 123(3), as amended, makes the obligations tied to a functional electronic system apply from the date corresponding to six months after publication of the Article 34(3) notice for that system.¹ For the systems in Decision (EU) 2025/2371, the Commission states that date as from 28 May 2026.³ Article 29(4) then says that, before placing a device other than a custom-made device on the market, the manufacturer enters or verifies the relevant Eudamed information.¹⁰

Point (e) is the later deadline for entering information that Article 29 requires. The replacement text says:

no later than 12 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), points (a) and (b), manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 29 is entered in that electronic system, including regarding the following devices, provided that those devices are also placed on the market from 6 months from the date of publication of that notice— MDR Article 123(3)(e), replaced by Article 1(6)(b) of Regulation (EU) 2024/1860

• Point (e)(i): devices, other than custom-made devices, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52.¹
• Point (e)(ii): devices, other than custom-made devices, placed on the market pursuant to Article 120(3), (3a) or (3b), unless the device for which the manufacturer has undertaken a conformity assessment in accordance with Article 52 is already registered in Eudamed.¹

The notice for this period is the notice for the device-registration system and the UDI database, Article 33(2), points (a) and (b). Decision (EU) 2025/2371 is that notice for those systems, together with actor registration and market surveillance.² The 12-month formula is measured from publication of that notice. The article does not print 27 November 2026 or 28 November 2026.

MDCG 2024-11, Question 7, states the operational test. Device registration in the UDI/DEV module is at device-identifier level. One registration covers the units that share that identifier. For a Regulation device, the identifier is the UDI-DI. For a legacy device, it is the EUDAMED ID or a UDI-DI.⁵

• First unit on or after mandatory use. If the first sales unit of a Regulation device with a given UDI-DI, other than a custom-made, investigational or performance-study device, is placed on the EU market on or after the mandatory-use date, the registration is done before that first unit is placed. The same timing applies to a system or procedure pack.⁵
• First unit before mandatory use, with further units after it. If the first sales unit of a legacy device or a Regulation device with a given UDI-DI was placed before mandatory use, and further units of the same UDI-DI are placed on or after that date, the registration is done within 12 months from publication of the notice. Question 7's worked example uses a hypothetical notice of 1 July 2025, mandatory use on 2 January 2026, and registration by 2 July 2026. Those dates illustrate the count. They are not this notice's calendar.⁵

The Commission graphic draws the same split for this notice. It places the first unit of a legacy or Regulation device before 28 May 2026, marks 28 May 2026 as mandatory use, tells the reader to register a Regulation device before placing its first unit on the market after that date, and prints 28 November 2026 as the deadline to register the device in the UDI/DEV module for additional units.⁴ A lot that carries a UDI-DI whose first Union unit was placed in 2023 can still be inside that 12-month period in October 2026. A new UDI-DI, including one created because the device changed enough to need a new identifier, is a first-unit case. Question 8 says a Regulation device that receives a new UDI-DI is not treated as the same device as the earlier one.⁵

Point (e)(ii) adds an unless-clause for legacy devices placed under Article 120(3), (3a) or (3b). The legacy device drops out of that registration duty when the Article 52 device is already registered in Eudamed. Question 8 explains the practical test: a legacy device does not need its own registration when the same device is already registered as a Regulation device, meaning the same identification, such as UDI-DI, catalogue or reference number, or trade name, following from shared characteristics. A legacy device that is still being placed, and that fails that test, stays in the 12-month period. Article 120 has its own conditions and end dates for whether the legacy device may be placed at all. This page does not restate those end dates. A missing device record during the 12-month period is not, by itself, evidence that the Article 120 conditions are met.

Question 7 also says custom-made devices, investigational devices and devices for performance studies are not registered in the UDI/DEV module. Question 8 adds two further gaps. Devices whose individual units are no longer placed when the module becomes mandatory do not need a device record unless a post-market surveillance or vigilance action later has to be filed in Eudamed. Old devices, in the sense used by the cited MDCG legacy guidance, cannot be registered in the module. Those are boundaries on the search result. They are not a general permission to ship.

Why Do 27 November and 28 November 2026 Both Appear?

Article 123(3)(e) says no later than 12 months from the date of publication of the notice. It does not name 27 November 2026 or 28 November 2026. Point (d) uses the same style of formula for six months. The civil days in circulation come from the Commission's own pages and from secondary calendars that do not match each other.¹

The Commission news page states two facts: Decision (EU) 2025/2371 was published in the Official Journal of 27 November 2025, and the first four modules are mandatory to use as from 28 May 2026.³ The transition graphic prints three further labels on that same timeline: 28 May 2026 as mandatory use of the UDI/DEV and notified-body modules, 28 November 2026 as the deadline to register the device for the additional-units case, and 28 May 2027 as the deadline to register MDR and IVDR certificates issued before mandatory use. It also says any new MDR or IVDR certificate issued from mandatory use should be registered in Eudamed.⁴

Question 7's hypothetical shows the counting pattern the Q&A uses. A notice published on 1 July 2025 makes the UDI/DEV requirements apply on 2 January 2026, and the continued-placement registration falls on 2 July 2026. Each landing day is the day after the month anniversary of the notice. Applied to a notice published on 27 November 2025, that is the same pattern as the dates the Commission prints: 28 May 2026 and 28 November 2026. The hypothetical dates themselves are not the live calendar.⁵

Secondary pages print both conventions. Celegence's table lists 27 November 2026 as mandatory registration of legacy devices, and the narrative also says existing product families must be uploaded by 27 November 2026. The same page says devices must be registered before being placed on the EU market from 28 May 2026.⁷ BSI's manufacturer table prints 27 May 2026 and 27 November 2026 as no later than six and twelve months after the 27 November 2025 notice, and its notified-body table prints 27 May 2027 as no later than 18 months. The narrative of the same brochure says the modules are mandatory to use from 28 May 2026, that registration of devices already placed is before 28 November 2026, and that certificates issued before mandatory use are registered before 28 May 2027.⁸

EUDAPrep states that the legacy-device deadline lands on 28 November 2026 and attributes that civil day to Decision (EU) 2025/2371.⁶ The decision confirms functionality and enters into force on publication. It does not print 28 November 2026. The graphic does. MEDIcept's note of 2 October 2026 states a 28 November 2026 deadline for certain legacy and Regulation devices first placed before mandatory use, which matches the graphic's additional-units case.¹¹ These pages are evidence of how the date is being repeated. They are not a second statute.

For a warehouse procedure, the date the Commission has printed for the continued-placement device record is 28 November 2026. This page does not convert the statutory formula through a separate time-limit regulation, and it does not treat 27 November 2026 as the legal end of the period. A company may stop relying on the window earlier. That earlier stop is its own buffer, and the file should say so. Celegence's 27 November date is real as a statement on that page. It is not the date on the Commission graphic.

The same calendar month contains an unrelated Commission date. The public consultation on the first review of the International Procurement Instrument runs from 4 September to 27 November 2026.¹² That consultation is a trade-policy review. It is not Article 123(3)(e). The tender article on this site is the other 27 November 2026 date, which is a tender consultation.

Who Has to Enter the Record, and What Can a Distributor Check?

Article 29 puts the device entry on the manufacturer. 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, and enters or verifies the Eudamed information in Article 29(4).¹⁰ Point (e) times that manufacturer duty for the devices it lists. It does not move the duty to the importer or the distributor.

For a manufacturer established outside the Union, Article 11 requires a sole authorised representative. Article 11(3)(c) requires that representative to comply with the registration obligations in Article 31 and to verify that the manufacturer has complied with Articles 27 and 29. The mandate does not turn Article 29 into the representative's own product registration.¹⁰ Article 31 is the actor registration of manufacturers, authorised representatives and importers in the electronic system set up by Article 30. After the competent authority verifies the data, it issues the SRN. Article 31(3) says the manufacturer uses the SRN when accessing Eudamed to fulfil Article 29.¹⁰ Question 3 says that actor registration is what enables the manufacturer to register devices, and that it became mandatory six months after the actor-module notice.⁵ Decision (EU) 2025/2371 Article 1(a) is the notice for that actor system.²

Importers and distributors verify different things. Article 13(2) requires an importer, before placing a device on the market, to verify the CE marking, the EU declaration of conformity, the identification of the manufacturer and the authorised representative, the labelling and instructions, and, where applicable, that a UDI has been assigned. Article 13(4) adds that the importer verifies that the device is registered in the electronic system in accordance with Article 29 and adds its details to the registration in accordance with Article 31.¹⁰ In October 2026 that registration check is read with Question 7. A continued-placement UDI-DI can still be unregistered inside the 12-month period. A first unit placed on or after 28 May 2026 cannot.

Article 14(2) requires a distributor, before making a device available, to verify the CE marking, the EU declaration of conformity, the information supplied under Article 10(11), the importer's Article 13(3) particulars on imported devices, and, where applicable, that a UDI has been assigned. The distributor may use a sampling method for the CE, information and UDI checks. Article 14(2) does not contain Article 13(4)'s duty to verify the Eudamed device registration. Question 5 says distributors are not required to register in Eudamed.⁵¹⁰ Where a distributor has reason to believe a device is not in conformity, Article 14(2) says it shall not make the device available until it has been brought into conformity. A first unit placed after 28 May 2026 with no device record is a reason of that kind. A continued-placement record that is still inside the 12-month period is not, by itself, the same reason.

There is no statutory form called an EUDAMED compliance declaration. The practical file, for an empty public search, is the manufacturer's answer to Question 7: the UDI-DI on the unit being received, the date the first sales unit of that UDI-DI was placed on the Union market, whether further units are being placed now, the Basic UDI-DI or the legacy identifier that will be searched, and the SRN. The public site is the place to repeat the search.⁹ The pack carrier encodes the UDI-DI level. It is not a second printing of the Basic UDI-DI, so a difference between the barcode and the Basic UDI-DI is the wrong mismatch to escalate.

When Is a Missing Certificate a Different Clock?

Article 1(6)(c) of Regulation (EU) 2024/1860 inserts point (ea). It is a notified-body duty, measured from the notice for the certificates system in Article 33(2), point (d). Decision (EU) 2025/2371 includes that system in the same notice as the device system, so the publication date is the same 27 November 2025 publication.¹²

no later than 18 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), point (d), notified bodies shall ensure that the information to be entered in Eudamed in accordance with Article 56(5) is entered in that electronic system, including regarding devices referred to in point (e)(i) of this paragraph; for those devices, only the latest relevant certificate and, where applicable, any subsequent decision taken by the notified body related to such certificate shall be entered— MDR Article 123(3)(ea), inserted by Article 1(6)(c) of Regulation (EU) 2024/1860

There is no point (ea)(i). Question 10 supplies the timing the graphic draws. Any certificate issued after the notified-body module becomes mandatory is registered in that module. For certificates issued in accordance with the MDR or IVDR before mandatory use, the notified body registers the related information within 18 months after the notice, only for Regulation devices that need to be or are registered in the UDI/DEV module, and only the latest certificate version and any latest decision on that version.⁵ The graphic prints that backfill as 28 May 2027, and it says a new MDR or IVDR certificate issued from mandatory use should be registered from that point.⁴

A missing upload of an older MDR or IVDR certificate is therefore a different finding from a missing device record. It can remain outstanding until the 18-month period ends, and the importer still keeps the certificate itself. An adverse status on a certificate that is already in the module is a reason to stop. The status table and the five-check workflow live in why a missing older CE certificate is not the same finding. Point (ea) is an Article 56(5) duty. It does not upload Directive certificates, and it does not extend the manufacturer's Article 29 deadline.

Two neighbouring points are easy to fold into the November date, and they do not belong there. Point (eb) says the summary of safety and clinical performance, and the Article 55(1) scrutiny notification, go through the certificates system for point (e) devices when the certificate is entered under point (ea).¹ Point (ec) says that when a manufacturer submits a PSUR, a serious incident, a field safety corrective action or a trend report through the vigilance system in Article 33(2), point (f), it also registers that device in the device system, except a device placed on the market under Directive 90/385/EEC or 93/42/EEC. Decision (EU) 2025/2371 does not declare the vigilance system functional, so point (ec) is not running on the November device date.

Systems and procedure packs use the same first-unit test in Question 7. Article 29(2) requires the person who places an Article 22(1) or 22(3) system or procedure pack, other than a custom-made device, to assign a Basic UDI-DI and provide the core data before placing it. An Article 22(4) combination is treated as a device in its own right and is registered as a device.⁵¹⁰ Whether the pack is a separate regulatory object is the subject of when a procedure kit is a separate regulatory object. This page only times the record.

A Hold-or-Release Check for October and November 2026

Use one identifier at a time. The checks below are a file sequence for the importer who has Article 13(4), and for the distributor who needs to know whether there is a reason to believe the device is not in conformity.

1. Fix the identifier. Record the UDI-DI on the unit, or the legacy identifier the manufacturer will register. A catalogue family with two UDI-DIs is two tests.⁵
2. Date the first Union unit of that identifier. If that first unit is placed on or after 28 May 2026, Article 29 required the record before the placing. Hold an unregistered shipment. If the first unit was placed before 28 May 2026 and this shipment is a further unit, the missing record can remain inside Article 123(3)(e) through the date the Commission graphic prints, 28 November 2026.¹⁴
3. Apply the legacy unless-clause only with the registered Regulation device in hand. Point (e)(ii) and Question 8 remove a separate legacy record when the same device is already registered under Article 52. Ask for that record and for the shared identification. Article 120 remains a separate placing test.¹⁵
4. Keep the certificate on its own line. A missing Eudamed upload of an MDR or IVDR certificate issued before 28 May 2026 follows point (ea) and Question 10, which the graphic prints through 28 May 2027. A certificate issued from mandatory use is registered as it is issued. An adverse status is a hold. The device-record line does not move with the certificate line.⁴⁵
5. Check the label duties that Article 13 and Article 14 actually name. Confirm the CE marking, the declaration of conformity, the instructions, a UDI where one is required, and, for an imported device, the importer's Article 13(3) name and address. Search the public actor and device modules with the SRN and the identifier from step 1.⁹¹⁰ Repeat the device search before release if the shipment is relying on the 12-month period and the release date is close to 28 November 2026.

Where VEMERIX Fits—and Where Due Diligence Still Begins

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

The circumcision device page lists CE as yes, NMPA registration Lu Mech Reg. 20172020238, and Class II on that page.¹³ That Class II label is the classification printed on the product page. It is not an MDR class. This article does not assign the device an SRN, a Basic UDI-DI, or an EU risk class, and the product page is not an EUDAMED record. A public device search that returns no row is the Question 8 question: whether any unit of that device is being placed on the Union market. The manufacturer census on this site already shows how to read an empty search, including for a manufacturer that is not placing devices in the EU. This page does not repeat or refresh that search: how to read a zero EUDAMED device result.

The laser fiber page lists an NMPA Class II single-use fiber, registration Lu Mech Reg. 20192010517, for 1470 nm endovenous use, paired with a partner-supplied diode laser source.¹⁴ The NOVACURE console page identifies that source as partner-supplied. The registration holder named there is Guangdong Yunshang, under Guo Xie Zhu Zhun 20253011190.¹⁵ Weihai Medison does not manufacture or register that console. A fiber and a console are separate device records if either one is placed on the Union market.

The quality page describes ISO 13485 and ethylene-oxide sterilization at the Weihai plant.¹⁶ Those statements support a quality-system conversation. They do not show whether a given UDI-DI has been placed in the Union, and they do not close the Question 7 test. A distributor preparing an EU shipment starts with the identifier, the first-unit date, and the public search, then requests the technical pack through the contact page.

Frequently Asked Questions

Does a missing certificate mean the device record may also wait until May 2027?
No. Point (ea) times the notified body's entry of Article 56(5) information. Question 10 applies the 18-month backfill to MDR and IVDR certificates issued before mandatory use of the certificates module, and the Commission graphic prints 28 May 2027 for that backfill.¹⁴⁵ The manufacturer's device record follows point (e) and Question 7. A certificate that is still inside the upload period does not move the device-record date.

If the manufacturer does not place devices in the EU, is a zero EUDAMED result a late filing?
No. Article 29 is a duty that arises before placing on the Union market.¹⁰ Question 8 says devices whose units are no longer placed when the module is mandatory do not need a UDI/DEV record unless a later vigilance action has to be filed in Eudamed.⁵ An empty search is the expected result when no unit is placed in the Union. The manufacturer census explains how that reading was applied to one public search. This page does not refresh it.

Does the vigilance module use this same November date?
No. Decision (EU) 2025/2371 Article 1 confirms actors, UDI and devices, notified bodies and certificates, and market surveillance.² Vigilance and post-market surveillance sit in Article 33(2), point (f). Clinical investigations sit in Article 33(2), point (e). Article 30 is the actor-registration system, and it is one of the four systems the decision confirms.¹⁰ Question 12 says vigilance obligations apply six months after their own functionality notice. Question 13 says that, until then, national vigilance processes continue.⁵ Point (ec) can require a device registration at the moment a report is submitted through that vigilance system. It does not apply the November device date to vigilance.

Is the 27 November 2026 date in the EU tender article this same deadline?
No. The Commission's trade news of 10 September 2026 says the public consultation on the first review of the International Procurement Instrument runs from 4 September to 27 November 2026.¹² That is a consultation close under the procurement instrument. Article 123(3)(e) is the device-record formula, and the Commission graphic prints 28 November 2026 for the continued-placement device record.

Can an EU distributor register the device for an overseas manufacturer?
Article 29 leaves the device entry with the manufacturer.¹⁰ Article 11(3)(c) requires the authorised representative to complete its own Article 31 registration and to verify that the manufacturer has complied with Articles 27 and 29. Question 5 says distributors are not required to register in Eudamed.⁵ A distributor's Article 14 check is the conformity verification described above, including the reason-to-believe stop.

What about units the manufacturer already placed before 28 May 2026?
Question 7's 12-month period is about further units placed on or after mandatory use. Question 8 says that where individual units are no longer placed from the mandatory-use date, the device does not need a UDI/DEV record unless a vigilance action later has to be filed in Eudamed.⁵ Making available a unit the manufacturer has already placed is a different act from placing a further unit. The importer's file should say which of those two acts the shipment is.