Saturday, June 22, 2024

Medical Devices Update: G-BA Removes mosquito® med LäuseShampoo from Approved List

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The Gemeinsame Bundesausschuss (G-BA) has announced the removal of mosquito® med LäuseShampoo 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 G-BA, according to § 31 Absatz 1 Satz 2 and 3 of the Fifth Book of the Social Code (SGB V) and related guidelines, sets out cases where substances and preparations considered medical devices can be included in drug supply. The mosquito® med LäuseShampoo was initially included in 2011 for children and adolescents with developmental disorders to treat head lice.

G-BA Removes mosquito® med LäuseShampoo After Medical Devices Market Withdrawal

Recent evaluations prompted a reclassification review following legislative changes. As of April 5, 2024, the manufacturer confirmed the product’s market withdrawal, leading to its removal from the G-BA’s approved list. This decision reflects the ongoing efforts to ensure that only safe and effective medical devices are available to the public.

The removal process was initiated on January 23, 2024, when the G-BA began assessing the continued eligibility of mosquito® med LäuseShampoo under new risk classification standards. The manufacturer’s confirmation of the product’s market discontinuation in April 2024 paved the way for its delisting. The G-BA followed standard procedures, involving the Medical Devices subcommittee and subsequent plenary session approval on June 6, 2024. This removal does not require a public consultation process, as it is based on the manufacturer’s request. The thorough review ensures that all aspects of patient safety and regulatory compliance are considered.

Medical Devices

G-BA Streamlines Medical Devices List: No New Obligations or Costs for Service Providers

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.

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.

 

Resource: Gemeinsame Bundesausschuss, June 10, 2024

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