MDCG 2019-8: Implant card — guidance for manufacturers, explained
What information the implant card must carry and how to provide it.
MDCG 2019-8 v2 turns the MDR implant-card obligation into a usable card design. It separates the information the manufacturer must supply from the patient and implantation details completed by the healthcare provider, and it explains UDI presentation, symbols, language and system cards.
Who this applies to
Manufacturers of implantable devices covered by MDR Article 18 must supply an implant card with the device, together with the patient information required by the regulation. Healthcare institutions or providers complete the patient-specific fields and give the card to the patient under national arrangements.
Article 18 contains exemptions for specified implant types. Confirm that the obligation applies to your product before designing the card; do not infer scope from the examples in the guidance.
What goes on the card
The manufacturer and healthcare provider own different fields:
Supplied by the manufacturer |
Completed by the healthcare provider |
|---|---|
Device name and device type |
Patient name or patient ID |
Serial number or lot/batch number |
Name and address of the implanting institution or provider |
UDI in automatic-identification format and UDI-DI in human-readable form |
Date of implantation |
Manufacturer name and address |
|
Manufacturer information website |
The UDI-DI in human-readable form should be introduced by “UDI-DI”. The device type must be understandable in the language required by the Member State. The guidance recommends a credit-card-sized format and text at least 2 mm high.
Symbols reduce translations, but do not eliminate them
MDCG 2019-8 recommends symbols for recurring fields such as patient identity, implantation date, manufacturer, serial number, lot number and UDI. Explain the symbols on the back of the card or in the accompanying leaflet.
There is no universal symbol that replaces the device-type wording. Supply that term in the accepted national language or provide the appropriate language-specific sticker. The instructions for completing the card and the symbol explanation also follow Member State language requirements.
The leaflet is part of the workflow
The guidance recommends an instruction leaflet showing the healthcare professional how to complete the chosen card design. The manufacturer should evaluate through ergonomic analysis or usability testing whether the instructions are sufficient.
This leaflet is not a substitute for the separate patient information required by Article 18(1)(b)–(d), such as warnings, expected lifetime and follow-up information. Treat the card, completion instructions and patient information as related but distinct deliverables.
Systems and replaceable components
For an implantable system whose components may later be replaced, consider a foldable system card that can be updated without losing the history or identity of the other components. Define how replacement-component information reaches the healthcare provider and how the existing card is updated.
What this means for you, practically
- Confirm scope and national rules. Record the Article 18 rationale and the languages required in every target market.
- Choose the operating model. Decide which information is pre-printed and which is supplied as controlled stickers; avoid making assembly at the hospital unnecessarily fragile.
- Verify the identifiers. Test AIDC scanning, human-readable UDI-DI, serial or lot linkage and the manufacturer website on production-equivalent cards.
- Usability-test completion. Give representative healthcare professionals the card, leaflet and realistic device information, then check legibility and completion errors.
- Control changes. Connect card artwork, language variants, UDI data, patient-information pages and component replacement to the same change process.
Related resources
MDCG guidance
MDCG 2019-9: Summary of safety and clinical performance (SSCP)
What the SSCP for implantable and class III devices must contain, and how to write it for both audiences.
MDCG guidance
MDCG 2023-7: Exemptions from clinical investigations
When Article 61(4)–(6) lets you rely on existing data instead of a new clinical investigation.
MDCG guidance
MDCG 2022-7: UDI Q&A
Practical answers on Basic UDI-DI grouping, identifier changes, labels, packaging, systems, procedure packs, kits and direct marking.
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