The lowest-risk IVDs in Europe are the last products to get a barcode duty on their label.
They are also the only products where nobody independent looks at that label before an inspector does.
If you make buffer solutions, washing solutions, culture media, histological stains or specimen receptacles for the EU market, that combination is your 2027 problem. You have about twenty-one months.
What actually switches on for IVD manufacturers on 26 May 2027?
Two things, and both live in the final provisions.
The first is the UDI carrier duty. Article 113(3)(e) reads: "for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027".
Class D has carried it for three years. Class B and class C have carried it since last May. Class A is the last tranche of a staged application that recital 97 describes as varying "from one to five years after the date of application of this Regulation depending upon the class of the device concerned." IVDR itself has applied since 26 May 2022 under Article 113(2).
The second is the Article 74 procedure. Article 113(3)(g) reads: "The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14)."
What does not change on that date is worth stating plainly. Article 24(3) already binds you. You already assign a UDI before placing a device on the market, and you already ensure the device's core data elements reach the UDI database referred to in Article 25. The 2027 date is not about the identifier. It is about the physical carrier.
Which of your products are class A under Annex VIII Rule 5, and why were they left until last?
Annex VIII Rule 5 classifies three groups as class A:
→ Products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination
→ Instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures
→ Specimen receptacles
Read that as a closed list, not a residual bucket. Rule 6 says devices not covered by the classification rules are class B. So the default direction of travel under IVDR is upward. If a product does not sit inside one of Rule 5's three limbs, it is not class A, whatever your legacy IVDD self-declaration said.
Two boundary conditions catch people. "Accessories which possess no critical characteristics" is a qualified carve-out, not a blanket accessory rule. And an instrument only lands in Rule 5 if it is intended by the manufacturer specifically for IVD procedures. General-purpose laboratory hardware repurposed with an IVD intended purpose is a classification conversation, and Annex II requires you to document the risk class and the justification for the classification rule applied.
They were left until last because the phase-in is risk-ranked. Recital 97 frames it as a smooth introduction of the UDI system. The practical effect is that the tier with the largest SKU counts, the smallest labels and the thinnest regulatory affairs function got the longest runway and the least scrutiny.
What does Article 24(4) require that Article 24(3) does not?
Article 24(3) is an assignment and data duty. Before placing a device on the market you assign a UDI created under the rules of the designated issuing entity, and you make sure the core data elements are correctly submitted and transferred to the UDI database.
Article 24(4) is a physical duty: "UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers."
Article 24(1) shows the architecture. Point (a) is production of the UDI, splitting into UDI-DI and UDI-PI. Point (b) is placing of the UDI on the label of the device or on its packaging. Point (c) is storage of the UDI by economic operators, health institutions and healthcare professionals. Point (d) is the UDI database.
The carrier itself is defined in Part C of Annex VI as the means of conveying the UDI using AIDC and, if applicable, its human readable interpretation. Section 4.1 of that Part restates the placement rule and confirms higher levels do not include shipping containers. Annex I section 20.2(g) puts "the UDI carrier as referred to in Article 24 and Part C of Annex VI" into the list of particulars the label shall bear.
Two adjacent duties tend to get missed on class A files. Article 24(6) requires the Basic UDI-DI to appear on the EU declaration of conformity referred to in Article 17, which Annex IV point 3 repeats. Article 24(7) requires you to keep an up-to-date list of all UDIs you have assigned as part of the Annex II technical documentation.
Where can the UDI carrier go for a single-use class A device packaged and labelled individually?
This is the one exemption that matters commercially, and it comes with a carve-back.
Annex VI Part C section 4.3: for single use class A and class B devices packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, for example a carton containing several packages. However, when the healthcare provider is not expected to have access to the higher level of device packaging, in cases such as home healthcare settings, the UDI shall be placed on the packaging.
So the answer is conditional on distribution model, not on the device. The same individually wrapped specimen receptacle can be exempt in a hospital supply chain and in scope in a home-collection kit. That is a per-SKU, per-channel determination you have to be able to evidence.
Three neighbouring provisions in the same section change the engineering answer:
→ 4.2 lets you move the carrier to the next higher packaging level where there are significant space constraints on the unit of use packaging → 4.12 removes the requirement to place a carrier on the packaging if it is readily readable or scannable through that packaging → 4.7 lets you drop to AIDC only where constraints limit both formats, except for devices intended to be used outside healthcare facilities, such as home care, where the HRI shall appear on the label even if that leaves no space for the AIDC
Note what 4.7 does. For home-use products it inverts the priority and protects the human readable format. Read it alongside 4.3 and home healthcare becomes the strictest case in the class A set, not the most relaxed.
Class A is self-certified under Article 48(10), so who checks the label before a market surveillance authority does?
Article 48(10) is the spine of this whole piece. Manufacturers of class A devices declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III. A notified body appears only where the device is placed on the market in sterile condition, and its involvement is limited to the aspects relating to establishing, securing and maintaining sterile conditions.
The tier that receives the label duty last is the tier no notified body reviews. Nobody audits your carrier placement decision before it reaches the market.
What is left is downstream verification. Under Article 13(2), importers verify that the device is labelled in accordance with the Regulation and that, where applicable, a UDI has been assigned in accordance with Article 24. Under Article 14(2), distributors verify that a UDI has been assigned, and may do it using a sampling method representative of the devices they supply.
Sampling. That is the control standing between a class A labelling defect and a market surveillance finding. If you sell through distribution, your carrier decision is now a third-party risk question as much as a regulatory affairs one.
Why does the Article 74 coordinated assessment procedure start on the same date, and what does Article 74(14) change until 27 May 2029?
Article 74 is the coordinated assessment procedure for performance studies. It is not a vigilance mechanism.
The sponsor of a performance study running in more than one Member State may submit a single application through the electronic system referred to in Article 69. The Member States concerned agree a coordinating Member State within six days, failing which the sponsor's proposal stands. The coordinating Member State notifies the sponsor within six days, assesses completeness within 10 days of the notification date, transmits a draft assessment report within 26 days of the validation date, collects comments by day 38, and transmits the final assessment report within 45 days of the validation date. Article 74(6) allows the coordinating Member State a further 50 days for class C and D devices to consult experts. Each Member State concerned then notifies by one single decision within five days.
Article 74(14) is the qualifier that Article 113(3)(g) preserves. Until 27 May 2029 the procedure is applied only by those Member States in which the studies are to be conducted that have agreed to apply it. After 27 May 2029, all Member States shall be required to apply it.
For most class A manufacturers this is background. Rule 5 products rarely anchor multi-state interventional performance studies. It matters if you also hold higher-class assets, because 26 May 2027 lands two workstreams on the same calendar quarter.
What should a class A IVD manufacturer have finished by Q4 2026?
Artwork is a print-run problem before it is a regulatory one. Working back from 26 May 2027, the compliance work needs to be closed this year.
→ Freeze the class A list. Test every SKU against Rule 5 (a), (b) and (c), and record the Annex II justification of the classification rule applied. Anything that fails Rule 5 falls to class B under Rule 6, where the carrier duty has already been live since 26 May 2025.
→ Decide the carrier level per SKU under Annex VI Part C 4.1 to 4.3, and record whether the product is single use, individually packaged, and whether the healthcare provider is expected to reach the higher packaging level.
→ Reconcile the Article 24(7) list of assigned UDIs in your Annex II file against what is actually in the UDI database under Articles 24(3) and 25.
→ Confirm the Basic UDI-DI appears on each EU declaration of conformity, per Article 24(6) and Annex IV point 3.
→ Brief importers and distributors on their Article 13(2) and Article 14(2) checks, and agree the sampling method they will run.
→ Confirm the registration plumbing holds: Basic UDI-DI and device registration under Article 26, and economic operator registration and SRN under Article 28.
Every line above traces to a verbatim clause. That is the point. If you make IVDs, see how your obligations map with the article-level citation attached, and how the same organizational profile resolves IVDR against everything else in your scope. Answer once. Assess everything.
FAQ: IVDR class A UDI carriers and the 26 May 2027 date
Does the 26 May 2027 date mean class A devices have no UDI obligations today? No. Article 24(3) already requires assignment of the UDI and submission of core data to the UDI database before placing the device on the market. Article 113(3)(e) defers only Article 24(4), the duty to place the carrier on the label and higher levels of packaging.
Do UDI carriers have to go on shipping containers? No. Article 24(4) states that higher levels of packaging "shall not be understood to include shipping containers." Annex VI Part C section 4.1 repeats the exclusion.
Can a single-use class A device skip the carrier on its individual packaging? Under Annex VI Part C 4.3, yes, if it is packaged and labelled individually and the carrier appears on a higher level such as a carton. The exemption reverses where the healthcare provider is not expected to have access to that higher level, for example in home healthcare settings.
Does a notified body review class A labelling before market? Only for sterile class A devices, and Article 48(10) limits that involvement to establishing, securing and maintaining sterile conditions. Otherwise the manufacturer self-declares under Article 17, and the first external checks are importer and distributor verification under Articles 13(2) and 14(2).
