Saturday, June 15, 2024

Medical Devices Update: G-BA Removes Paranix® ohne Nissenkamm from Approved List

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The Gemeinsame Bundesausschuss (G-BA) has announced the removal of Paranix® ohne Nissenkamm from the approved medical devices list in Germany. This decision was made during the G-BA meeting on June 6, 2024, and affects children under 12 and adolescents up to 18 with developmental disorders. The changes take effect immediately upon publication in the Bundesanzeiger. This regulatory update is crucial for healthcare providers and patients who have relied on this product for treating head lice infestations. The prompt removal ensures that the standards for medical devices remain stringent and aligned with current health and safety regulations.

Paranix® ohne Nissenkamm was initially included on the list to provide an effective solution for managing head lice, particularly for younger patients and those with developmental challenges. However, recent evaluations and legislative changes necessitated a thorough review of the product’s safety and efficacy. By removing this product from the list, the G-BA aims to protect vulnerable patient groups from potential risks associated with its use. The decision underscores the importance of continuous monitoring and reassessment of medical devices to ensure they meet the highest standards of care.

Healthcare providers who have been prescribing Paranix® ohne Nissenkamm must now seek alternative treatments that comply with the latest regulatory standards. This transition is vital to maintaining patient safety and ensuring that treatments for head lice are both effective and safe. The removal of this product also highlights the G-BA’s proactive approach in adapting to new health regulations and scientific advancements. By doing so, the G-BA ensures that only the most reliable and thoroughly vetted medical devices are available to patients.

G-BA Ensures Patient Safety with Immediate Delisting of Paranix® ohne Nissenkamm

The immediate effect of this decision upon publication signifies the urgency and importance of adhering to updated safety standards. It reflects the G-BA’s commitment to patient health and its rigorous processes in evaluating medical devices. Patients and healthcare providers can be assured that such measures are taken with the utmost consideration for public health. This regulatory update serves as a reminder of the dynamic nature of medical device regulation and the ongoing efforts to enhance patient care quality and safety.

The G-BA operates under § 31 Absatz 1 Satz 2 and 3 of the Fifth Book of the Social Code (SGB V) and related guidelines, which outline when substances and preparations considered medical devices can be included in drug supply. Initially, Paranix® ohne Nissenkamm was included for children up to 12 years old and adolescents up to 18 with developmental disorders for head lice treatment.

However, the inclusion criteria have become stricter following legislative updates, leading to a re-evaluation of the product’s classification. As of March 14, 2024, the manufacturer confirmed the market withdrawal of the product, resulting in its delisting from the G-BA’s approved list. This decision ensures that only products meeting the latest safety and efficacy standards remain available. The stringent review and reclassification process highlights the G-BA’s commitment to upholding high regulatory standards and protecting patient safety.

Medical Devices

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.

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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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