In 2019, the national implant registry (“Implantateregistergesetz – IRegG) has been introduced to guarantee quality and safety standard in healthcare with implants.
The implant register will be apply for:
- endoprostheses (hip, knee, shoulder, elbow and ankle joint)
- breast implants
- cardiac valves and other cardiac implants
- implantable defibrillators and pacemakers
- neurostimulators
- cochlea implants
- vertebral body replacements, vertebral disc prostheses and
- stents
From a Reimbursement and Market Access point of view, the register is relevant because the Reimbursement of treatments with implants depends on the report by the respective hospital as well as the implant manufacturer to the register (according to para 35 IRegG).
The medical device industry will therefore facer further new administrative tasks to label and categorize their affected products.
Please find here more on the topic of product specific Reimbursement in Germany.
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