This document has been approved by the Medical Device Coordination Group (MDCG) created by article 103 of EU Regulation 2017/745.
It provides advice on the global Implant Card (IC) scheme, which is a requirement of the MDR, and describes the intended use, content and information to be provided by the manufacturer with a definition of the fields to be completed by healthcare establishments or providers.
While the intended objective and most elements are already defined in Article 18 of the MDR, this document contains the description of the other elements on which information must be provided by healthcare establishments or providers under Article 18.
The introduction of an IC must make it possible to meet three main objectives:
- Enable patients to identify the implanted devices and give them access to other information concerning this device (for example via EUDAMED and other websites),
- Enable patients to be identified as a person requiring particular attention in certain situations, for example during safety checks,
- Enable the emergency services or first responder to be aware of the particular treatments to be carried out on the patient in case of emergency.
ANALYSis
In accordance with Article 18, 1a), manufacturers must provide the following information on the IC (preferably on the card itself or in the form of stickers attached by healthcare staff):
- Device name,
- Serial number, batch number,
- Unique Device Identification (UDI), UDI in AIDC4 format and UDI-DI in HRI5 format,
- Manufacturer’s name, address and website,
- Device model.
Article 18, 2 states that Member States must oblige healthcare establishments (or providers) to make the IC available to the patient concerned.
The IC must show their identity. The IC provided with the device must therefore also contain the following blank fields, to be completed by the healthcare establishment or provider:
- Patient name or identity,
- Name and address of the healthcare establishment or provider that implanted the device,
- Implant date.
To meet the requirements described in Article 18, the external dimensions on the IC must be identical to those of a credit card or identity card (85.60 mm × 53.98 mm) and with a radius of 2.88 to 3.48 mm³.
The text provided on the IC and on the completion instructions for the healthcare establishment or provider must be legible and at least 2 millimetres in height. The term “text” includes figures, letters, symbols or letters or figures in a symbol.
To avoid the need for national versions of the IC, the use of symbols is recommended.
The following list contains the symbols validated by users, which have been submitted and approved for inclusion in a future international standard or which already exist in the ISO database (Online navigation platform).
An explanation of the symbols on the IC must be provided in the instructions or on the rear of the IC, if space permits.
Article 18, Paragraph 1, states that the information provided on the IC must be drafted in the language(s) specified by the Member State concerned.