Modular Medical Announces BSI Group as Trusted Body for CE Mark Clearance
Modular Medical (NASDAQ:MODD) has engaged BSI Group as its notified body to pursue CE Mark clearance for its MODD1 insulin pump in the European market. The company, which has already secured FDA clearance for its patch pump, is targeting Q1 2026 for European regulatory approval.
Unlike the U.S. process, EU clearance requires a third-party notified body to conduct audit steps and certify compliance with CE mark standards. Once obtained, the CE mark allows the device to be marketed and sold in Europe and other regions that recognize this certification.
The MODD1 aims to address European market challenges including high pump costs, environmental impact, and usage complexity. The company positions its device as a solution offering simplicity, cost-effectiveness, lower carbon footprint, reusable electronics, and an attractive form factor to encourage adoption among multiple daily injectors.
Modular Medical (NASDAQ:MODD) ha ingaggiato il BSI Group come organismo notificato per perseguire l'approvazione del marchio CE per la sua pompa per insulina MODD1 nel mercato europeo. L'azienda, che ha già ottenuto l'approvazione della FDA per la sua pompa a patch, punta a Q1 2026 per l'approvazione normativa europea.
A differenza del processo negli Stati Uniti, l'approvazione dell'UE richiede che un organismo notificato di terze parti esegua passaggi di audit e certifichi la conformità agli standard del marchio CE. Una volta ottenuto, il marchio CE consente al dispositivo di essere commercializzato e venduto in Europa e in altre regioni che riconoscono questa certificazione.
Il MODD1 mira a affrontare le sfide del mercato europeo, tra cui i costi elevati delle pompe, l'impatto ambientale e la complessità d'uso. L'azienda posizione il suo dispositivo come una soluzione che offre semplicità, economicità, un'impronta di carbonio ridotta, elettronica riutilizzabile e un design attraente per incoraggiare l'adozione tra gli utenti di iniezioni quotidiane multiple.
Modular Medical (NASDAQ:MODD) ha contratado al BSI Group como su organismo notificado para buscar la aprobación del marcado CE para su bomba de insulina MODD1 en el mercado europeo. La compañía, que ya ha obtenido la aprobación de la FDA para su bomba de parche, tiene como objetivo Q1 2026 para la aprobación regulatoria europea.
A diferencia del proceso de Estados Unidos, la aprobación de la UE requiere que un organismo notificado de terceros realice pasos de auditoría y certifique el cumplimiento de los estándares del marcado CE. Una vez obtenido, el marcado CE permite que el dispositivo sea comercializado y vendido en Europa y otras regiones que reconocen esta certificación.
El MODD1 busca abordar los desafíos del mercado europeo, incluidos los altos costos de las bombas, el impacto ambiental y la complejidad de uso. La empresa posiciona su dispositivo como una solución que ofrece simplicidad, rentabilidad, una huella de carbono reducida, electrónica reutilizable y un factor de forma atractivo para fomentar la adopción entre los inyectores diarios múltiples.
모듈러 메디컬 (NASDAQ:MODD)은 유럽 시장에서 MODD1 인슐린 펌프에 대한 CE 마크 승인을 추진하기 위해 BSI Group를 통지 기관으로 고용했습니다. 패치 펌프에 대한 FDA 승인을 이미 받은 회사는 유럽 규제 승인을 2026년 1분기로 목표하고 있습니다.
미국의 절차와는 달리, EU 승인을 위해서는 제3자 통지 기관이 감사 절차를 수행하고 CE 마크 기준에 대한 준수를 인증해야 합니다. CE 마크를 취득하면 해당 장치를 유럽 및 이 인증을 인정하는 다른 지역에서 판매할 수 있습니다.
MODD1은 높은 펌프 비용, 환경 영향 및 사용의 복잡성과 같은 유럽 시장의 문제를 해결하고자 합니다. 회사는 이 장치를 여러 번의 일일 주사를 하는 사용자들이 채택할 수 있도록 단순성, 비용 효율성, 낮은 탄소 발자국, 재사용 가능한 전자 장치 및 매력적인 형태를 제공하는 솔루션으로 포지셔닝합니다.
Modular Medical (NASDAQ:MODD) a engagé le BSI Group en tant qu'organisme notifié pour obtenir le marquage CE de sa pompe à insuline MODD1 sur le marché européen. L'entreprise, qui a déjà obtenu l'approbation de la FDA pour sa pompe à patch, vise Q1 2026 pour l'approbation réglementaire européenne.
Contrairement au processus américain, l'approbation de l'UE nécessite qu'un organisme notifié tiers réalise des étapes d'audit et certifie la conformité aux normes de marquage CE. Une fois obtenu, le marquage CE permet à l'appareil d'être commercialisé et vendu en Europe et dans d'autres régions qui reconnaissent cette certification.
Le MODD1 vise à relever les défis du marché européen, notamment les coûts élevés des pompes, l'impact environnemental et la complexité d'utilisation. L'entreprise positionne son appareil comme une solution offrant simplicité, rentabilité, une empreinte carbone réduite, une électronique réutilisable et un design attrayant pour encourager l'adoption parmi les utilisateurs d'injections quotidiennes multiples.
Modular Medical (NASDAQ:MODD) hat die BSI Group als benannte Stelle beauftragt, um die CE-Kennzeichnung für ihre MODD1 Insulinpumpe auf dem europäischen Markt zu erlangen. Das Unternehmen, das bereits die FDA-Zulassung für seine Patch-Pumpe erhalten hat, strebt die europäische Zulassung für Q1 2026 an.
Im Gegensatz zum Verfahren in den USA erfordert die EU-Zulassung, dass eine benannte Stelle von Dritten Auditschritte durchführt und die Einhaltung der CE-Kennzeichnungsstandards zertifiziert. Nach Erhalt der CE-Kennzeichnung kann das Gerät in Europa und anderen Regionen, die diese Zertifizierung anerkennen, vermarktet und verkauft werden.
Die MODD1 zielt darauf ab, die Herausforderungen des europäischen Marktes zu bewältigen, darunter hohe Pumpenkosten, Umweltbelastungen und Nutzungskomplexität. Das Unternehmen positioniert sein Gerät als Lösung, die Einfachheit, Kosteneffizienz, einen geringeren Kohlenstoff-Fußabdruck, wiederverwendbare Elektronik und eine ansprechende Form bietet, um die Akzeptanz bei Nutzern mehrerer täglicher Injektionen zu fördern.
- Already has FDA clearance for MODD1 insulin pump
- Initiated CE Mark clearance process with established notified body
- Clear timeline for European market entry (Q1 2026)
- Product addresses specific market needs (cost, environmental impact, usability)
- European market entry not expected until Q1 2026
- Additional regulatory hurdles and audit steps required for EU approval
Insights
The selection of BSI Group as the notified body for CE mark clearance is a strategically significant development for Modular Medical's expansion plans. BSI Group, known for its rigorous standards and extensive experience in medical device certification, adds credibility to MODD1's European regulatory journey.
The European insulin pump market presents a substantial opportunity, characterized by:
- Lower pump penetration rates compared to the U.S., creating significant growth potential
- A heightened focus on environmental sustainability, aligning with MODD1's reusable electronics design
- Healthcare systems that favor cost-effective solutions, where MODD1's affordability could drive adoption
The Q1 2026 timeline for CE mark clearance appears realistic given the typical 12-18 month process for Class III medical devices. This regulatory pathway involves comprehensive quality management system audits, technical documentation review and clinical evidence assessment. The company's existing FDA clearance may expedite certain aspects of the process, as some technical documentation and clinical data can be leveraged.
The European market entry strategy targets a critical gap in the insulin delivery sector. With an estimated 60 million people with diabetes in Europe and historically low pump adoption rates due to cost and complexity barriers, MODD1's user-friendly design and competitive pricing could catalyze market expansion. The focus on environmental sustainability through reusable components also aligns with European healthcare providers' increasing emphasis on reducing medical waste.
From an investment perspective, this regulatory initiative represents a important value-creation milestone. Success in obtaining CE marking would open access to not only the EU market but also to numerous countries that recognize CE marking, potentially multiplying the addressable market significantly. However, investors should note that regulatory timelines can be subject to delays and market penetration post-approval will require substantial commercial infrastructure development.
- Engaged BSI Group to start the process of obtaining regulatory clearance of the MODD1, next-generation insulin pump for the European market
- Targeting Q1 2026 for expected clearance of the MODD1 in the E.U.
SAN DIEGO, CALIFORNIA / ACCESS Newswire / January 30, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), an insulin delivery technology company with the first FDA-cleared patch pump designed specifically to target all adult "almost-pumpers" with its user-friendly and affordable design, announced that BSI Group will serve as the notified body for the European regulatory clearance process.
Unlike the U.S. process, European Union ("E.U.") clearance of a medical device is driven by a series of audit steps driven by a third party, known as a notified body, retained by the sponsor of the device to determine safety and efficacy, and the notified body then certifies that the CE mark standards have been met. Once the CE mark is obtained, a device can be marketed and sold in Europe and other areas that rely on the CE mark. BSI Group will serve as the notified body for Modular Medical for its CE clearance process.
"The MODD1 insulin pump is an ideal fit for the European marketplace," stated Jeb Besser, CEO of Modular Medical. "With U.S. clearance in hand, we are focusing our regulatory efforts on the opportunity in the E.U. In Europe, pump penetration has been challenged with its high cost, considerable environmental impact and complexity of use. We believe that our combination of simplicity to learn and use and the low cost of our device, combined with its lower carbon footprint, reusable electronics and attractive form factor for the patient, will motivate more multiple daily injectors to adopt pumping."
Modular Medical currently believes that it will obtain the CE mark during the first quarter of 2026.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statements contained in this press release, including but not limited to, whether the Company can obtain the CE mark for the European market; potential market opportunities in the E.U. and other areas where the CE mark is accepted; the Company's ability to convert patients to use its MODD1 pump; the occurrence of future events or circumstances; successful development of Modular Medical's proprietary technologies; whether the market will accept Modular Medical's products and services; anticipated consumer demand for the Company's products; whether Modular Medical can successfully manufacture its products at high volumes; and general economic, industry and political conditions in the United States or internationally, as well as other risk factors and business considerations described in Modular Medical's SEC filings, including its annual report on Form 10-K. Any forward-looking statements in this press release should be evaluated in light of these important risk factors. In addition, any forward-looking statements included in this press release represent Modular Medical's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. Modular Medical assumes no obligation to update these forward-looking statements, except as required by law.
About Modular Medical
Modular Medical, Inc. (NASDAQ:MODD) is a development-stage medical device company that intends to launch the next generation of insulin delivery technology. Using its patented technologies, the company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Our mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond "superusers" and providing "diabetes care for the rest of us."
Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump. More information is available at https://modular-medical.com.
All trademarks mentioned herein are the property of their respective owners.
CONTACT:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
+1 (617) 399-1741
IR@modular-medical.com
SOURCE: Modular Medical, Inc.
View the original press release on ACCESS Newswire
FAQ
When is Modular Medical (MODD) expecting to receive CE Mark clearance for MODD1?
What are the key differences between FDA and CE Mark clearance process for MODD1?
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