G-BA’s Rigorous Review Leads to Delisting of Paranix® ohne Nissenkamm
The removal process began on March 14, 2024, when Perrigo Deutschland GmbH submitted a request to delist Paranix® ohne Nissenkamm. The G-BA reviewed the application thoroughly, involving the Medical Devices subcommittee and the Working Group on Medical Products. The review process included multiple meetings: on November 16, 2023, January 18, 2024, and March 21, 2024.
The final decision to remove the product from the approved list was made in a plenary session on June 6, 2024. This detailed and structured process ensures that all necessary considerations are addressed before a medical device is delisted. Each stage of the review process is meticulously documented, ensuring transparency and accountability in the decision-making process. This structured approach guarantees that the delisting is justified and in the best interest of public health.
G-BA Streamlines Delisting Medical Devices Process with No Added Bureaucratic Costs
The G-BA confirmed that no new or modified information obligations for service providers arise from this decision, meaning there are no associated bureaucratic costs. The entire procedural timeline involved multiple subcommittee meetings, starting from November 2023 to the final decision in June 2024. The process included reviews, evaluations, and consensus on the necessity of delisting the product from the medical devices list. This efficient handling underscores the G-BA’s commitment to maintaining a streamlined and transparent regulatory process.
By adhering to these procedures, the G-BA ensures that the highest standards of patient safety and product efficacy are upheld. The clear and concise procedural guidelines provide a roadmap for future delistings, ensuring consistency in regulatory practices. This decision ensures that only compliant and necessary medical devices are listed, aligning with current regulatory standards. The G-BA’s transparent approach and adherence to procedural guidelines reflect its commitment to maintaining an updated and relevant list of medical devices. This transparency and adherence to established protocols bolster public trust in the regulatory system.
As a result, healthcare providers can confidently rely on the integrity of the medical devices listed by the G-BA. This confidence is crucial for maintaining the quality of patient care and ensuring that treatments are both safe and effective. The regulatory landscape for medical devices remains robust, with ongoing evaluations to meet the evolving standards of healthcare.
Resource: Gemeinsame Bundesausschuss, June 06, 2024
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