MDR Article 18 requires every manufacturer of an implantable device to provide, together with the device, a patient implant card and the information set out in Annex I Chapter III Section 23.3 of Regulation (EU) 2017/745. The card must identify the device (name, type, serial number, lot number, UDI, and device model), identify the manufacturer (name, address, website), and carry any warnings, precautions, or measures the patient or a healthcare professional needs to know about reasonably foreseeable external influences, medical examinations, or environmental conditions. It must also state the expected lifetime and any necessary follow-up. The healthcare institution that implants the device is responsible for making the card available to the patient, with the patient's identity added. The card and the accompanying information must be written in a way that is readily understood by a lay person, in the official Union language(s) required under Article 10(11). A short list of implant types is exempted under Article 18(3): sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. For every other implantable device, the implant card is mandatory.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • MDR Article 18 creates a direct obligation on every manufacturer of an implantable device to provide a patient implant card together with the device, alongside the information listed in Annex I Chapter III Section 23.3.
  • Section 23.3 specifies the content: device identification, manufacturer identification, warnings and precautions about external influences and medical examinations, expected lifetime, and any necessary follow-up.
  • The UDI carrier under MDR Article 27 is part of the device identification set and belongs on the card.
  • The distribution chain is defined in Article 18(1): the manufacturer supplies the card with the device, and the health institution that implants the device makes the card available to the patient with the patient's identity filled in.
  • The card and its accompanying information must be written so a lay person can understand them, and must be in the official Union language(s) required by each Member State under Article 10(11).
  • Article 18(3) exempts a specific, closed list of implant types. Everything else is in scope.

Why the implant card exists

The implant card is the surface that accompanies the patient out of the clinic. A patient with an implanted pacemaker who walks into an MRI suite ten years after implantation has to be able to tell the radiographer what is inside them, who made it, and what electromagnetic fields it can and cannot tolerate. A dentist asked about a hip replacement needs to know whether antibiotic prophylaxis applies. An emergency physician in another country needs to identify the device quickly enough to act on it. None of this works if the only record of the implant lives in a hospital database the patient cannot access.

The pre-MDR situation was uneven. Some manufacturers supplied cards voluntarily, some did not, the content varied by manufacturer, and the distribution chain from manufacturer to patient was unreliable. MDR Article 18 closed the gap. It converted the implant card from a courtesy into a legal obligation and tied the content to Annex I Chapter III Section 23.3 so that every manufacturer supplies the same core information in the same structure.

For startup manufacturers of implantable devices, the implant card is therefore not optional, not a marketing asset, and not a design choice. It is a regulated deliverable that has to be in the technical documentation, verified for content against Section 23.3, approved for language against Article 10(11), and reviewed for lay-user understandability the same way the instructions for use are.

The Article 18 obligation

Article 18 of Regulation (EU) 2017/745 is titled "Implant card and information to be supplied to the patient with an implanted device." Paragraph 1 establishes the core obligation. The manufacturer of an implantable device must provide, together with the device, the information referred to in Section 23.3 of Annex I, including a patient implant card. The information must be made available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information. It must be written in a way that is readily understood by a lay person, and must be updated where appropriate. (Regulation (EU) 2017/745, Article 18(1).)

Paragraph 2 assigns a separate obligation to Member States. Member States must require health institutions to make the information, together with the patient implant card which has the identity of the patient, available to patients who have been implanted with the device. (Regulation (EU) 2017/745, Article 18(2).) This is where the distribution chain closes. The manufacturer supplies the card and the information with the device; the health institution is responsible for handing the card, with the patient's identity added, to the patient.

Paragraph 3 lists the exemptions. The obligations of Article 18 do not apply to the following implantable devices: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. The Commission is empowered, by means of delegated acts, to amend this list by adding or removing implants. (Regulation (EU) 2017/745, Article 18(3).) This list is closed. If your device is not on it, Article 18 applies in full.

Who gets an implant card

Every implantable device is in scope unless the device type is on the Article 18(3) exemption list. "Implantable device" is defined in Article 2(5) of the Regulation as any device, including those that are partially or wholly absorbed, which is intended to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Long-term surgical invasive devices that are intended to be partially introduced into the human body by clinical intervention and to remain in place for at least 30 days are also considered implantable devices. (Regulation (EU) 2017/745, Article 2(5).)

The effect of the Article 18(3) exemptions is narrow. Sutures and staples come out. Simple orthopaedic and dental hardware. Screws, plates, wires, pins, wedges, clips, connectors, dental fillings, dental braces, tooth crowns. Comes out. Everything else stays in. Pacemakers, cochlear implants, hip and knee joint replacements, spinal fusion systems, cardiovascular implants, neurostimulators, drug-eluting stents, orthopaedic implants with active components, surgical meshes that remain in place, breast implants. All in scope. If you are not certain whether your device is exempted, the default assumption is that the obligation applies. The exemption list in Article 18(3) is the only escape, and it is written as a closed list.

Required information under Annex I Chapter III Section 23.3

Annex I Chapter III Section 23.3 of Regulation (EU) 2017/745 sets out the information that must be supplied with the implant card and with the device. The section lists the categories that must appear. In plain language, the information supplied with the implantable device must enable:

  • Identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address, and website of the manufacturer.
  • Any warnings, precautions, or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations, or environmental conditions.
  • Any information about the expected lifetime of the device and any necessary follow-up.
  • Any other information to ensure safe use of the device by the patient, including the information in Section 23.4(u). The summary of safety and clinical performance for implantable and Class III devices where required.

(Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.3.)

The structure of Section 23.3 matters. The first bullet is device and manufacturer identification. The "who and what" the card carries so that anyone reading it years later can identify the implant and reach the manufacturer. The second bullet is the safety information. The MRI compatibility statement for devices with metallic or electronic components, the electromagnetic interference notes for active implants, the diathermy contraindications, the dental-imaging considerations for ferromagnetic implants, the environmental limits. The third bullet is the lifetime and follow-up information. How long the implant is expected to function and what the patient needs to do at regular intervals. The fourth category extends the information set to cover anything else the patient needs for safe use.

The card itself does not have to carry the complete text of every warning. Article 18(1) and Section 23.1 between them allow the information to be distributed: the card carries the items that travel with the patient, and the accompanying information. The document supplied with the device alongside the card. Carries the detailed content. The two together must satisfy Section 23.3 in full.

Multi-language obligations

MDR Article 10(11) sets the language obligation. The manufacturer must ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language or languages determined by the Member State in which the device is made available to the user or patient. (Regulation (EU) 2017/745, Article 10(11).) This applies uniformly to the label (Section 23.2), the implant card and accompanying information (Section 23.3), and the instructions for use (Section 23.4).

Two specific consequences follow for implant cards. First, the card and the accompanying information must be written "in a way that is readily understood by a lay person" (Article 18(1)). Meaning that even within the required official Union language, the language register has to be plain, not technical. A cardiologist can read technical instructions; a patient cannot. The card is for the patient. Second, the language must match the Member State where the device is supplied to the patient. A device implanted in a patient in France needs the French language version; a device implanted in Germany needs German. Member States publish their own requirements, and for lay-user information most Member States require the national language.

The practical consequence is that translation for the implant card is not optional and not deferrable. Before a device is placed on a given national market, the implant card and the Section 23.3 accompanying information must be available in the language(s) that Member State requires. Every added market multiplies the translation and version-control load.

The UDI on the card

Section 23.3 explicitly names the UDI as part of the device identification set. MDR Article 27 governs the UDI system and requires the UDI carrier to be placed on the label of the device and on all higher levels of packaging. The UDI is composed of a UDI-DI (device identifier, identifying the specific device model) and a UDI-PI (production identifier, identifying the specific production instance. Lot, serial number, expiry, or manufacturing date depending on the device). (Regulation (EU) 2017/745, Article 27.)

On the implant card, the UDI serves a different purpose than on the packaging label. On the packaging it is for traceability through the supply chain. On the implant card it is for traceability through the patient's life. Ten years after implantation, a clinician scanning the card's UDI should be able to resolve back to the exact device model and production instance. This makes the human-readable component of the UDI on the card critical. The patient may not have a scanner, and any healthcare professional they encounter may not either. Print the UDI in a form that a human can read and transcribe without a scanner, alongside the machine-readable form where the format allows.

The card must carry enough identification to support the UDI-PI's purpose. Serial number for patient-specific devices, lot number for batch-produced devices. In addition to the UDI itself. Section 23.3 lists the serial number and lot number as separate required elements alongside the UDI, and the Section 23.3 text makes both mandatory where applicable to the device.

The distribution flow

The implant card moves through a defined chain from manufacturer to patient.

  • Manufacturer. Designs the card and the accompanying Section 23.3 information set. Prints the card with the device identification fields pre-filled at production (device name, model, serial/lot number, UDI, manufacturer details), leaving the patient identity fields blank. Supplies the card and the accompanying information with the device. Maintains the card and the accompanying information under document control in the technical documentation.
  • Distributor and importer. Transports the card with the device without altering it. Does not complete the patient identity fields. Stores the card with the device until implantation.
  • Health institution. Receives the device and the card with it. At the time of implantation, completes the patient identity fields on the card. Hands the card to the patient together with the accompanying Section 23.3 information. Records the implantation in the institution's own records per Article 18(2) and national law.
  • Patient. Carries the card, presents it to healthcare professionals when relevant (MRI, dental work, surgery, emergency care, travel), and retains the accompanying information for reference.

The manufacturer's responsibility ends where the health institution's begins, but the manufacturer has to design the card so that the chain actually works. Patient identity fields clearly marked, instructions to the health institution on how to complete the card, durability that survives decades in a wallet, and content that a lay person can understand without calling the hospital.

Common mistakes startups make with implant cards

The same failure modes show up repeatedly in first-time implant card designs.

  • Treating the card as a label add-on. The card is governed by Article 18 and Section 23.3, not by Section 23.2. The content overlaps with the label but the purpose, surface, and distribution chain are different. Designing the card by copying the label misses the Section 23.3 content that is not on the label.
  • Writing the card in technical language. Article 18(1) requires language a lay person can understand. A card that reads like an engineering specification is non-compliant on that ground alone.
  • Missing the expected lifetime and follow-up statements. Section 23.3 requires both. Many first drafts cover identification and MRI safety but omit the lifetime and follow-up categories entirely.
  • Supplying the card in only one language. Article 10(11) applies to Section 23.3. Every target Member State needs its required language(s).
  • Omitting the UDI from the card. Section 23.3 lists the UDI explicitly. A card without it fails the identification requirement.
  • Failing to leave space for the health institution to complete the patient identity fields. The card is supplied blank for those fields by design; omitting the fields entirely means the health institution cannot complete its Article 18(2) obligation.
  • Assuming Article 18(3) exemptions apply when they do not. The exemption list is closed and narrow. Any device type not on the list is in full scope.
  • Not placing the card and the Section 23.3 information under document control in the technical documentation. The card is a Chapter III deliverable and belongs in the file under Annex II the same way the label and the IFU do.

The Subtract to Ship angle on implant cards

The implant card attracts the same bloat as the label and the IFU. Legal wants a disclaimer. Marketing wants a logo block. Engineering wants every specification printed. The result is a card that is physically too crowded to be usable and still missing one of the mandatory Section 23.3 categories because nobody applied a checklist discipline to it.

Subtract to Ship for the implant card is the same move applied to the same problem. Start from the Section 23.3 list. Device identification, manufacturer identification, warnings and precautions about external influences and medical examinations, expected lifetime, necessary follow-up, and any other information needed for safe use by the patient. Add the UDI per Article 27. Require language readable by a lay person per Article 18(1). Require the official Union language(s) per Article 10(11). Cut everything else. A card where every element traces to one of those sources is compliant, usable, and cheap to translate. A card with marketing bloat is none of those things. See the Subtract to Ship framework for MDR compliance for the broader methodology.

Reality Check. Where do you stand?

  1. Is your device implantable, and if so, have you confirmed it is not on the closed Article 18(3) exemption list?
  2. Does your implant card include every Section 23.3 category. Device identification, manufacturer identification, warnings and precautions about external influences and medical examinations, expected lifetime, and necessary follow-up?
  3. Does the card carry the UDI (both UDI-DI and UDI-PI where applicable) in a form a human can read without a scanner?
  4. Is the card and the accompanying Section 23.3 information written in language a lay person can understand, verified by usability review rather than by assumption?
  5. Is the card available in the official Union language(s) required by every Member State where the device is supplied, per Article 10(11)?
  6. Does the card leave clearly marked space for the health institution to complete the patient identity fields at implantation?
  7. Is the card, the accompanying information, and the process for supplying them with the device under document control in your technical documentation under Annex II?

Frequently Asked Questions

Which MDR article requires an implant card? MDR Article 18 of Regulation (EU) 2017/745 requires manufacturers of implantable devices to provide a patient implant card together with the device, along with the information specified in Annex I Chapter III Section 23.3. The obligation applies to every implantable device except the types listed in Article 18(3).

What has to be on the implant card? Annex I Chapter III Section 23.3 specifies the content: device identification (device name, serial number, lot number, UDI, device model), manufacturer identification (name, address, website), warnings and precautions about reasonably foreseeable external influences and medical examinations, expected lifetime of the device, and any necessary follow-up. Additional information needed for safe use by the patient is also included.

Which implant types are exempted from Article 18? Article 18(3) exempts sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. The list is closed. Every other implantable device is in full scope. The Commission may amend the list by delegated act.

Who is responsible for giving the card to the patient? The manufacturer supplies the card and the accompanying information with the device. Under Article 18(2), Member States require the health institution that implants the device to make the card available to the patient with the patient's identity filled in. The chain is manufacturer to health institution to patient.

Does the implant card need to include the UDI? Yes. Annex I Chapter III Section 23.3 explicitly names the UDI as part of the device identification set. The UDI carrier follows the rules of Article 27. On the card, the UDI should be presented so a human can read it without a scanner, because the card is expected to support identification years after implantation in settings where scanning equipment may not be available.

What language does the implant card have to be in? Article 10(11) requires the information to be in the official Union language(s) determined by the Member State where the device is made available to the patient. Article 18(1) adds that the information must be written in a way that is readily understood by a lay person. Both obligations apply together: the required language, and within that language a plain register a patient can follow.

Is the implant card part of the technical documentation? Yes. The implant card and the accompanying Section 23.3 information are Chapter III deliverables, and like the label and the IFU they belong in the technical documentation held under Annex II. The version history, the translations, and the process for supplying them with the device are all under document control per EN ISO 13485:2016+A11:2021.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 2(5) (definition of implantable device), Article 10(11) (language of information supplied with the device), Article 18 (implant card and information to be supplied to the patient with an implanted device), Article 27 (Unique Device Identification system), Annex I Chapter III Section 23.3 (information on the implant card and information to be supplied to the patient with an implanted device). Official Journal L 117, 5.5.2017.
  2. EN ISO 15223-1:2021. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements.

This post is part of the Technical Documentation & Labeling cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The implant card is the one regulated surface a patient keeps for the life of the implant. Design it from Section 23.3, write it for a lay reader, translate it for every market, and let the regulation, not the brand, decide what it carries.