MDCG 2019-8 v2 : Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices – March 2020

23 Nov 2020 | MDCG

Theme Implant Card
Target Audience Manufacturers
Products Concerned Implantable MD
Regulatory reference MDR (EU) 2017/745

Article 18
Documents mentioned ISO database (Online Browsing Platform)

ISO 15223-2

ISO/IEC 7810 ID-1

 

This document clarifies the contents of the implant card. In particular, it specifies that the manufacturer must provide empty fields to be completed by the healthcare professional or institution performing the implantation.

It also provides information on :

  • the dimensions of the implant card
  • the size of the text so that it is readable
  • the symbols to be used
  • the instructions that come with the implant card