The MDCG released on 1st of July 2019 a Guidance on the Implant Card (IC) disciplined by MDR Article 18 and on information to be provided to the patient with an implanted device.
The document goes beyond what already included in Art. 18 and focuses on data to be provided by the healthcare institution or healthcare provider and which must be taken into account by the implementing Member State according to Art. 18.
IC should be designed to include blank fields to be filled in by the healthcare provider as to include:
- Name of the patient or patient ID;
- Name and address of the healthcare institution which performed the implantation;
- Date of implantation.
The guidance document provides a list of symbols, either validated by users or already recognized as ISO symbols, to be included on the IC. As no symbol is yet available for the device type, it is important for the information on the device type to be provided in a language accepted/required by the Member State. Explanation of these symbols should be included in a leaflet to be provided together with the IC. The leaflet should as well include information on how to complete the IC and the instructions contained therein should be subject to a risk assessment to check whether the health professional has all the necessary information to complete the IC.
The MDCG Guidance is very useful as it provides examples on how an implant card should be designed (Annex I of the document).
Check other MDCG guidance in our Library of Documents.