Sonoma Pharmaceuticals Successfully Transitions First Products to New EU MDR Requirements for Class IIb Medical Devices
Sonoma Pharmaceuticals (Nasdaq:SNOA) has successfully transitioned four of its products to meet the new European Union Medical Device Regulation (MDR) requirements, achieving Class IIb medical device classification. The products include Microdacyn60® Wound Care, Microdacyn60 Hydrogel, Epicyn® (scar gel), and Pediacyn® for atopic dermatitis.
The EU MDR, adopted in 2017 to replace the Medical Device Directive, requires compliance by December 31, 2028 for non-implantable Class IIb and lower risk devices. The classification was granted after the products met safety and performance requirements and passed conformity assessment, demonstrating their compliance with the new, more stringent European standards.
Sonoma Pharmaceuticals (Nasdaq:SNOA) ha completato con successo la transizione di quattro dei suoi prodotti per soddisfare i nuovi requisiti del Regolamento sui Dispositivi Medici dell'Unione Europea (MDR), ottenendo la classificazione come dispositivo medico di Classe IIb. I prodotti includono Microdacyn60® Wound Care, Microdacyn60 Hydrogel, Epicyn® (gel per cicatrici) e Pediacyn® per la dermatite atopica.
Il MDR dell'UE, adottato nel 2017 per sostituire la Direttiva sui Dispositivi Medici, richiede conformità entro il 31 dicembre 2028 per i dispositivi di Classe IIb e a rischio inferiore non impiantabili. La classificazione è stata concessa dopo che i prodotti hanno soddisfatto i requisiti di sicurezza e prestazione e hanno superato la valutazione di conformità, dimostrando la loro conformità ai nuovi standard europei più rigorosi.
Sonoma Pharmaceuticals (Nasdaq:SNOA) ha realizado con éxito la transición de cuatro de sus productos para cumplir con los nuevos requisitos del Reglamento de Dispositivos Médicos de la Unión Europea (MDR), logrando la clasificación como dispositivo médico de Clase IIb. Los productos incluyen Microdacyn60® Wound Care, Microdacyn60 Hydrogel, Epicyn® (gel para cicatrices) y Pediacyn® para la dermatitis atópica.
El MDR de la UE, adoptado en 2017 para reemplazar la Directiva de Dispositivos Médicos, requiere cumplimiento antes del 31 de diciembre de 2028 para dispositivos de Clase IIb y de menor riesgo que no sean implantables. La clasificación se otorgó después de que los productos cumplieran con los requisitos de seguridad y rendimiento y pasaran la evaluación de conformidad, demostrando su cumplimiento con los nuevos estándares europeos más estrictos.
소노마 제약 (Nasdaq:SNOA)는 유럽연합 의료기기 규정(MDR)의 새로운 요구 사항을 충족하기 위해 4개 제품을 성공적으로 전환하였으며, IIb 등급 의료기기 분류를 획득했습니다. 이 제품들은 Microdacyn60® Wound Care, Microdacyn60 Hydrogel, Epicyn® (흉터 젤), 그리고 Pediacyn® (아토피 피부염용)입니다.
2017년에 채택된 EU MDR은 의료기기 지침을 대체하며, 비임플란트 IIb 등급 및 그 이하의 위험 장치에 대해 2028년 12월 31일까지 준수를 요구합니다. 이 분류는 제품이 안전성 및 성능 요구 사항을 충족하고 적합성 평가를 통과한 후 부여되었으며, 새로운 보다 엄격한 유럽 기준에 대한 준수를 입증했습니다.
Sonoma Pharmaceuticals (Nasdaq:SNOA) a réussi à faire la transition de quatre de ses produits pour répondre aux nouvelles exigences du Règlement européen sur les dispositifs médicaux (MDR), obtenant ainsi la classification de dispositif médical de Classe IIb. Les produits incluent Microdacyn60® Wound Care, Microdacyn60 Hydrogel, Epicyn® (gel cicatriciel) et Pediacyn® pour la dermatite atopique.
Le MDR de l'UE, adopté en 2017 pour remplacer la Directive sur les dispositifs médicaux, exige une conformité d'ici le 31 décembre 2028 pour les dispositifs de Classe IIb et de risque inférieur qui ne sont pas implantables. La classification a été accordée après que les produits ont satisfait aux exigences de sécurité et de performance et ont réussi l'évaluation de conformité, démontrant leur conformité aux nouveaux standards européens plus stricts.
Sonoma Pharmaceuticals (Nasdaq:SNOA) hat erfolgreich vier Produkte umgestellt, um die neuen Anforderungen der Europäischen Union für Medizinprodukteverordnung (MDR) zu erfüllen und die Klassifikation als Medizinprodukt der Klasse IIb erreicht. Zu den Produkten gehören Microdacyn60® Wound Care, Microdacyn60 Hydrogel, Epicyn® (Narben-Gel) und Pediacyn® für atopische Dermatitis.
Die EU-MDR, die 2017 verabschiedet wurde, um die Medizinprodukte-Richtlinie zu ersetzen, verlangt die Einhaltung bis zum 31. Dezember 2028 für nicht implantierbare Medizinprodukte der Klasse IIb und niedrigerem Risiko. Die Klassifikation wurde vergeben, nachdem die Produkte die Sicherheits- und Leistungsanforderungen erfüllt und die Konformitätsbewertung bestanden hatten, wodurch ihre Konformität mit den neuen, strengeren europäischen Standards nachgewiesen wurde.
- Early compliance with EU MDR requirements, well ahead of 2028 deadline
- Successfully obtained Class IIb classification for four key products in Europe
- Demonstrated product safety and efficacy through regulatory compliance
- None.
Insights
The successful MDR transition for Sonoma's key products represents a significant regulatory achievement, particularly given the early compliance ahead of the 2028 deadline. The Class IIb classification is a higher-risk category that requires more rigorous safety and performance standards, validating the robustness of Sonoma's hypochlorous acid technology platform.
The MDR certification ensures continued market access in the EU, which is important for maintaining and potentially expanding European revenue streams. However, this regulatory milestone, while positive for operational continuity, doesn't immediately translate to new market opportunities or revenue growth. The early compliance might provide a competitive advantage over companies that haven't yet adapted to the new requirements.
The early MDR compliance positions Sonoma favorably in the European medical device market, where many competitors are still working towards meeting the 2028 deadline. For a micro-cap company with resources, achieving this regulatory milestone demonstrates operational efficiency and regulatory expertise. However, investors should note that while this maintains market access, it doesn't necessarily indicate expansion or revenue growth potential.
The company's proactive approach to regulatory compliance could reduce future regulatory risks and associated costs. This is particularly relevant given Sonoma's small market capitalization of approximately
BOULDER, CO / ACCESSWIRE / December 5, 2024 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has successfully completed transition to the new European Union (EU) Medical Device Regulation (MDR) for four of its products in Europe.
Sonoma was granted classification as a Class IIb medical device for Microdacyn60® Wound Care and Microdacyn60 Hydrogel, its scar gel product Epicyn®, and Pediacyn® for atopic dermatitis.
The MDR was adopted in the EU in 2017 to replace the existing Medical Device Directive. The transition period for compliance was most recently extended to December 31, 2028 for non-implantable Class IIb and lower risk devices. In order to comply with the MDR, Sonoma's products needed to meet certain requirements relating to safety and performance and successfully undergo verification of regulatory compliance, or conformity assessment.
"Sonoma is pleased to have received the new Class IIb classification for our wound care, scar and atopic dermatitis products in the European Union, well ahead of the requisite compliance deadline," said Amy Trombly, CEO of Sonoma. "It is truly a testimony to the safety and efficacy of our products and strength of our clinical data. This is an important milestone made possible by the diligent preparation of our regulatory team to meet these new and more stringent standards for medical devices in Europe."
About Sonoma Pharmaceuticals, Inc.
Sonoma Pharmaceuticals is a global healthcare leader for developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound, eye, oral and nasal care, dermatological conditions, podiatry, animal health care and non-toxic disinfectants. Sonoma's products are clinically proven to reduce itch, pain, scarring, and irritation safely and without damaging healthy tissue. In-vitro and clinical studies of HOCl show it to safely manage skin abrasions, lacerations, minor irritations, cuts, and intact skin. Sonoma's products are sold either directly or via partners in 55 countries worldwide and the company actively seeks new distribution partners. The company's principal office is in Boulder, Colorado, with manufacturing operations in Guadalajara, Mexico. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com. For partnership opportunities, please contact busdev@sonomapharma.com.
Forward-Looking Statements
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the "company"). These forward-looking statements are identified by the use of words such as "continue," "develop," "anticipate," "expect" and "expand," among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the company's products will not be as large as expected, the company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the company's cash needs, fund further development, and the ability to meet a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. The company disclaims any obligation to update these forward-looking statements, except as required by law.
Sonoma Pharmaceuticals™, Microcyn60®, Epicyn® and Pediacyn® are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.
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SOURCE: Sonoma Pharmaceuticals, Inc.
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FAQ
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