EU IVDR CE Marking under Article 18: Affixing Rules, Annex V and Notified Body Number

1. Key takeaways

The CE marking is the visible evidence that an in vitro diagnostic device may circulate freely within the Union. Under Article 10(5), the manufacturer affixes the CE marking of conformity in accordance with Article 18, after demonstrating conformity with the applicable conformity assessment procedure and having drawn up the EU Declaration of Conformity. Annex V sets out the form, proportions and visibility requirements of the marking. Where a conformity assessment procedure involves a notified body, the CE marking must be accompanied by the four-digit identification number of that body.

The CE marking is often treated as a label detail, but it is the final step of a regulated sequence, and misplacing it creates a non-conformity in its own right. The sequencing rule, the number of the notified body and the boundary rules for components, assemblies and devices for special purposes all deserve explicit procedures, because mistakes here are visible on every unit placed on the market and are among the first items checked during market surveillance.

2. Legal basis

3. Expert insights

Insight 1: The precondition for affixing the CE marking is that the procedure is completed, not that the product is finished.

The order under Article 10(5) is precise: complete the applicable conformity assessment procedure and demonstrate conformity, then draw up the EU Declaration of Conformity under Article 17, and only then affix the CE marking. Affixing the marking while any step of that sequence is missing constitutes a non-conformity in the sense of the market surveillance provisions under Articles 88 to 92. In manufacturing environments, this means the release of labelling artwork must be tied to the existence of the signed DoC and, where relevant, the notified body certificate. A product physically ready for shipment without a completed procedure must not carry the marking, and companies should design their labelling release controls so that this cannot happen even under delivery pressure.

Insight 2: The four-digit number is public information about who performed the assessment.

Notified bodies receive an identification number from the Commission and are listed under Article 39. Affixing that number next to the CE marking means that market surveillance authorities, purchasers and competitors can all trace the assessing body directly from the marking on the box. The number also connects directly to the notified bodies and certificates module of EUDAMED, where certificates and their status are recorded. From a brand perspective, the marking on the label is therefore a public statement about your assessment partner: when certificates change or bodies are replaced, the artwork must be switched in step, and inconsistencies between the printed number and the certificates held in EUDAMED are easy for third parties to detect and to query.

Insight 3: Articles 19 and 20 are two boundaries that are easily overlooked.

Article 19 addresses devices for special purposes, including specific situations such as custom-made devices, and sets the rules that apply to them instead of the general marking regime. Article 20 addresses parts and components, distinguishing when a part or component may bear the marking in its own right and when it is only covered as part of a complete device. Design files and external materials that treat a component as if it were a complete device, and affix the CE marking to it without satisfying Article 20, constitute marking beyond what the Regulation permits. Product managers and marketing teams should be trained on these boundaries, because the temptation to place the marking on subsystems and accessories sold separately is common and the rule is not intuitive without reading the text.

Insight 4: The CE marking is mutually exclusive with in-house devices under Article 5(5).

Devices manufactured and used within a health institution under Article 5(5) fall outside the scope of the Regulation except for the general safety and performance requirements, and they must therefore not bear the CE marking. Under Article 5(5)(f), the health institution draws up a public statement instead, which is a different instrument in both nature and audience from the marking. Health institution projects and their suppliers should document this distinction clearly: a device that begins as an in-house device and later moves to commercial distribution must go through the conformity assessment route before any CE marking appears, and the two regimes cannot be blended on the same labelling.

4. Practical recommendations

1. Establish an approval gate for the use of the CE marking, bound to the issuance of the DoC, so that labelling materials cannot be released for printing or application before the DoC has been signed.
2. Check the proportions, legibility and minimum dimensions of the marking against Annex V during the label and packaging design phase, not afterwards, so that artwork changes are not needed at release.
3. For products involving a notified body, fix the four-digit identification number in the label files and keep it consistent with the certificates and the data recorded in EUDAMED.
4. Manage parts, components and devices for special purposes as separate categories with their own marking decisions under Articles 19 and 20, so that the marking is not applied by default.
5. When changing notified body, plan the switching of certificates and labels together, handling the change of the identification number in line with the arrangements described for the transition of certificates.

5. Verification checklist

• □ The conformity assessment procedure has been completed and the DoC issued before affixing the CE marking, under Articles 10(5) and 17
• □ The form, proportions and visibility of the marking have been checked against Annex V
• □ The four-digit identification number of the notified body is affixed with the CE marking, where applicable
• □ Parts, components and devices for special purposes have been assessed separately for marking eligibility under Articles 19 and 20
• □ In-house devices of health institutions do not bear the CE marking, in line with Article 5(5)
• □ Label changes and certificate switching arrangements are synchronised for notified body changes

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with CE marking compliance under the IVDR: Annex V artwork checks, marking release controls linked to the DoC, notified body identification number management, component and special-purpose marking decisions, and label transition planning. Contact us at info@grzanglobal.com for a marking compliance review.

Legal information verified as of 29 October 2026.