Are you an implantable device manufacturer looking to meet your Article 18 obligations under Regulation (EU) 2017/745? This template provides everything you need.
An implant card is a personalised document issued to the patient following the implantation procedure that serves three defined purposes — enabling patients to identify their implanted device and access relevant information, supporting patients in situations requiring special attention such as security checks, and ensuring emergency responders are informed of any special care requirements in critical situations.
The Implant Card template covers all mandatory information including device name, model, UDI, and relevant warnings, alongside designated fields for healthcare institutions to complete with patient-specific details, in line with Article 18 of Regulation (EU) 2017/745 and MDCG 2019-8 v2. It applies to all implantable devices, unless explicitly exempted.
Experienced regulatory professionals have ensured this template reflects every requirement of Article 18, giving manufacturers a document that is accurate and compliant.
Price: $200
