Implant Card Under MDR Article 18: What Has to Be Supplied, in Which Language, and Who Checks It

Article 18 of MDR 2017/745 is short, and it is one of the few provisions written primarily for the patient rather than for the regulator. It requires the manufacturer of an implantable device to supply information with the device, to put a defined subset of that information on a physical card, and to write all of it so that a person without medical training can use it.

It is also a provision that non-EU manufacturers frequently discover late, because it has no counterpart in most third-country regimes. A file that is complete for the purposes of conformity assessment can still be missing a compliant card and a compliant patient information set. This guide sets out what the article requires, what it exempts, and where the EU authorised representative examines it.

The four categories of information

Paragraph 1 lists what has to accompany the device. "The manufacturer of an implantable device shall provide together with the device the following: (a) information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer; (b) 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; (c) any information about the expected lifetime of the device and any necessary follow-up; (d) any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I." (MDR Article 18(1))

Point (a) is identification. Note that it requires both a serial number and a lot number where both exist, and the UDI — which means the UDI assignment under Article 27 has to be settled before the card can be printed. Our guides to the Basic UDI-DI and to UDI carrier requirements cover that step.

Point (b) is the interference set. For an implant this is the material that matters in an emergency room: whether the device is conditional for magnetic resonance imaging, how it behaves near electrosurgical equipment, airport security systems, or diathermy. The drafting is deliberately broad — reasonably foreseeable external influences, medical examinations or environmental conditions — and a card that covers only MRI is usually incomplete.

Point (c) is expected lifetime and follow-up, which for an implant is a clinical statement and not a warranty period. Point (d) is a catch-all that routes back to Annex I, Section 23.4(u), the instructions-for-use requirement for implantable devices.

How the information has to be delivered

The delivery requirement sits in the second subparagraph: "The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph." (MDR Article 18(1))

Three obligations are packed into that paragraph. The information must be rapidly accessible, which is why the manufacturer's website appears in point (a) at all — it is the update channel, and it has to exist and stay current for the life of the implant. The information must be in the language determined by each Member State concerned, which is the same national competence that governs label and IFU language requirements. And it must be readily understood by a lay person, a readability standard that a technical instruction leaflet will not meet on its own.

Then the card itself: "In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device." (MDR Article 18(1)) The card carries the identification data; the rest of the information set travels with the device by other means.

What the health institution has to do

Article 18 does not stop at the manufacturer. "Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity." (MDR Article 18(2))

The words which shall bear their identity explain a design constraint that manufacturers sometimes miss: the card has to have space for the patient's identity to be added by the implanting institution, and for the institution's own details in most national implementations. A card printed edge to edge with device data, with no writable field, will be rejected by hospital procurement even where it technically carries every Article 18(1)(a) item.

The fourteen exempted implants

Paragraph 3 removes a defined list from the whole of the article: "The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom." (MDR Article 18(3))

The list is closed and literal. Screws, plates, wires and pins are named, which removes most osteosynthesis hardware from the card requirement. Dental fillings, braces and crowns are named, which is relevant to the workshops we cover on our dental instruments page. What is not named is not exempt: a spinal cage, a joint prosthesis, a breast implant, a cochlear device and a stent all require the card, and so does any implant that is merely similar to a listed item without being one.

The exemption is also from this Article only. An exempted implant still has to meet Annex I labelling and instruction requirements, still needs a UDI, and is still subject to the classification consequences of being implantable. It simply does not need the card.

Where implantable status changes the rest of the file

Implantable status is not only an Article 18 question. It moves the device up the classification rules, it engages the summary of safety and clinical performance in Article 32 for class III and implantable devices, and it lengthens the retention period. Article 10(8) requires the technical documentation to be kept available for at least ten years after the last device covered by the declaration of conformity has been placed on the market, and "in the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market" (MDR Article 10(8)).

That fifteen-year period is what the authorised representative undertakes to support. Article 11(3)(b) requires the representative to "keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8)" (MDR Article 11(3)(b)). For an implantable device that is a fifteen-year commitment, which is worth confirming in the mandate rather than assuming. Our guide to the authorised representative mandate agreement covers what else should be written down.

What an authorised representative checks

Article 11(3)(a) frames the representative's verification duty around the declaration of conformity, the technical documentation and the conformity assessment route. In practice, for an implantable device, that review looks at four things beyond the certificate itself.

Whether the card exists and carries every item in Article 18(1)(a), including the UDI in the form actually assigned. Whether the wider patient information covers interference, expected lifetime and follow-up rather than only device description. Whether language versions exist for each Member State where the device will be made available, and whether the readability of those versions is plausible for a lay reader. And whether the manufacturer's website named on the card is live and capable of hosting updates for the device's whole life — an obligation that outlasts most marketing sites.

None of that is a substitute for the notified body's assessment. It is the check that catches the file which is technically certified and practically unshippable.

Medex Kurumsal Danismanlik acts as EU authorised representative under MDR and IVDR, EUDAMED registration TR-AR-000057550, and reviews implant card and patient information content as part of the pre-mandate documentation review. Our scope and fee structure are set out on the EU authorised representative cost page.

Medex Kurumsal as your EU authorised representative

If you place medical devices or in vitro diagnostics on the European market from outside the Union, Article 11 of MDR 2017/745 — and Article 11 of IVDR 2017/746 for in vitro diagnostics — requires a single authorised representative established in a Member State before those devices reach the market. Medex Kurumsal Danismanlik acts as EU authorised representative under both Regulations, registered in EUDAMED under SRN TR-AR-000057550.

What the mandate covers: verification of the EU declaration of conformity and the technical documentation before signature rather than after; the Article 11(3)(a) copy of the file kept available for the full retention period; EUDAMED actor and device registration and the Basic UDI-DI submission; the registered EU address printed on your label and instructions for use; handling of competent authority requests, samples and information in the language of the Member State concerned; and the vigilance interface under Articles 87 to 90.

We review the file before accepting a mandate, because Article 11(5) makes the authorised representative jointly and severally liable for defective devices where the manufacturer has not complied with Article 10. A file we have not read is a liability we cannot price. Our fee structure is published on the EU authorised representative cost page, and the scope of the service is set out under EU authorised representative. Send us the declaration of conformity and the device list and we will tell you within two working days whether the file is ready for a mandate and what is missing if it is not.