IFU-Anatomie

Anatomy of an Implant Card

MDR Article 18 – Patient Information for Implantable Medical Devices

The first section of the implant card contains the patient's personal data: full name, date of birth, where applicable a unique hospital patient identifier, and details of known allergies or pre-existing conditions relevant to the implant. This section is typically completed by the implanting physician or clinic, either handwritten or electronically.

Challenge

Name fields must support diacritical marks and character sets of all EU languages — from Scandinavian special characters (å, ø) through Central European diacritics (č, ž, ł) to Greek and Bulgarian Cyrillic characters. Date formats vary considerably (DD.MM.YYYY in Germany, DD/MM/YYYY in France, YYYY-MM-DD in Sweden). Additionally, pre-printed field labels such as "Name," "Date of Birth," and "Allergies" must be precisely translated into the target language while the layout remains compact — the card typically has credit card format.

Solution with manualworks

manualworks generates language-specific implant card templates with correctly translated field labels, locale-appropriate date formats, and Unicode-compatible input fields. The layout is automatically adjusted to the text length of the target language, ensuring all information fits the prescribed card format even in more verbose languages.

According to MDR Annex III point (a), the implant card must enable identification of the patient. The processing of personal data is additionally subject to the GDPR (Regulation (EU) 2016/679), in particular Article 9 on the protection of special categories of personal data (health data).

Frequently Asked Questions

Does the implant card need to be translated into all official EU languages?+

Yes. Under MDR Article 18(1), the implant card must be provided to the patient in the language of the Member State where the implant is placed. Since patients with implants may travel within the EU and require emergency medical care in other countries, many Notified Bodies additionally recommend an English version. manualworks supports simultaneous creation in all required languages.

What information must appear on an implant card according to the MDR?+

MDR Annex III lists the minimum requirements: patient identification, product name and model, UDI, lot or serial number, manufacturer name and address, expected implant lifetime, warnings and precautions, and where applicable, MRI compatibility information. manualworks ensures that all mandatory information is complete and compliant in every language version.

How does the implant card differ from the instructions for use?+

The instructions for use (IFU) are primarily aimed at healthcare professionals and contain detailed technical information on application, implantation, and clinical operation. The implant card per MDR Article 18 is a document for the patient — it must be written in plain language and contains the essential information the patient needs to know about their implant, including emergency information. manualworks manages both document types in an integrated workflow with shared terminology.

Ready for better IFU translations?

Try manualworks for free — no credit card required.