Providing an implant card without clear instructions on how to complete it does not meet EU MDR requirements. The implant card leaflet bridges that gap.
Manufacturers are required to provide healthcare institutions with instructions on how to complete the implant card accurately, including an explanation of symbols used as per Article 18 of Regulation (EU) 2017/745 and MDCG 2019-8. These instructions must be provided in the language determined by the relevant Member State and must reflect the implant card format — whether pre-printed, blank with stickers, or a combination of both.
As part of the risk management process under ISO 14971, manufacturers must verify through usability testing that the instructions provided are sufficient for healthcare professionals to complete the implant card correctly.
The Implant Card Leaflet template gives manufacturers a complete, compliant document covering all required instructional content. Developed by experienced regulatory professionals, it ensures that this frequently overlooked document is produced as per regulatory expectations.
Price: $200
