Modular Medical Announces Positive Notified Body Decision on ISO 13485:2016 Certification

The company continues to target a 2027 CE Mark submission; ISO certification is separate from the additional regulatory review.

Rhea-AI Summary

Modular Medical (NASDAQ:MODD) received a positive notified body decision regarding certification of its medical device quality management system under ISO 13485:2016.

The standard covers quality management systems for medical devices, with certification demonstrating conformity through an independent audit within the certification's scope. The notified body is designated under the European Union Medical Device Regulation. Modular Medical continues to target calendar year 2027 for its CE Mark submission. ISO certification is separate from CE marking, which requires additional regulatory review. A CE mark, if obtained, would allow the company to pursue EU commercial distribution, subject to applicable regulatory and operational criteria.

Positive

• Minor pointPositive notified body decision advances ISO 13485:2016 quality management system certification.
• Minor point. Forward-looking: it has not happened yet and may not happen.CE Mark submission remains targeted for calendar year 2027.

Negative

• Minor pointCE marking requires additional regulatory review; EU distribution also depends on applicable regulatory and operational criteria.

Key Figures

CE Mark submission target: Calendar year 2027

CE Mark submission target

Calendar year 2027

Company-stated target following the notified body decision

Key Terms

iso 13485:2016, notified body, ce mark

3 terms

iso 13485:2016 regulatory

"certification of its quality management system under ISO 13485:2016"

ISO 13485:2016 is an internationally recognized standard that sets out requirements for a quality management system specific to manufacturers and suppliers of medical devices. Think of it as a rulebook and inspection checklist that helps ensure devices are designed, produced, and tracked consistently to meet safety and regulatory expectations. Investors care because certification lowers the risk of product recalls, regulatory penalties, and market delays, supporting more predictable costs and revenue.

notified body regulatory

"received a positive decision from its notified body"

An independent, government‑designated organization that inspects and certifies medical devices, diagnostic tests, and other regulated products to verify they meet safety and performance rules required for sale in certain markets. Think of it as an official inspector or stamp of approval: its approval affects whether a product can be legally marketed, the timing of launch, and the company’s costs and regulatory risk—key factors for investors assessing commercial prospects.

ce mark regulatory

"a CE mark under MDR requirements would allow the Company to pursue"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

SAN DIEGO, CA / ACCESS Newswire / October 27, 2026 / Modular Medical, Inc. ("Modular Medical" or "the Company") (NASDAQ:MODD), a commercial-stage medical device company preparing for the full commercial launch of its next-generation Pivot^™ tubeless patch pump, today announced that it has received a positive decision from its notified body regarding certification of its quality management system under ISO 13485:2016. The notified body is designated under the European Union Medical Device Regulation ("MDR").

"This positive decision represents another important milestone in our preparation for CE Mark submission, which we continue to target for calendar year 2027," said Jeb Besser, Chief Executive Officer of Modular Medical. "Receiving this positive decision underscores our commitment to bringing high quality diabetes technology to the European markets."

ISO 13485 is the internationally recognized standard for medical device quality management systems. Certification demonstrates, through independent audit, that Modular Medical's quality management system conforms to the applicable requirements of ISO 13485:2016 within the scope of certification. ISO 13485 certification is separate from CE marking, which requires additional regulatory review. If obtained, a CE mark under MDR requirements would allow the Company to pursue commercial distribution across the EU, subject to satisfying all applicable regulatory and operational criteria. There can be no assurance that the Company will obtain a CE mark on its anticipated timeline or at all.

About Modular Medical

Modular Medical, Inc. (NASDAQ:MODD) is a commercial-stage medical device company focused on the development of innovative insulin delivery technologies designed to simplify diabetes management and increase access to insulin pump therapy. The Company's Pivot^™ tubeless patch pump has been developed to provide a user-friendly, flexible, and accessible approach to insulin delivery for people requiring intensive insulin therapy.

About Pivot

The Pivot^™ tubeless patch pump is designed to offer a simplified approach to insulin delivery for individuals requiring intensive insulin therapy. Pivot was developed to address barriers that have limited broader adoption of insulin pump therapy among patients currently managing diabetes with multiple daily injections.

For more information, visit www.pivotpump.com.

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, the timing of issuance of the Company's ISO 13485:2016 certificate, the Company's ability to maintain ISO 13485:2016 certification, the timing and outcome of the Company's planned CE Mark submission and any related notified body review, the Company's ability to obtain CE marking and commercialize the Pivot insulin delivery system in the European Union, the 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, and industry or 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 most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. 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.

Pivot is a trademark of Modular Medical. All other trademarks mentioned herein are the property of their respective owners.

Company Contact

Jeb Besser, Chief Executive Officer
Modular Medical, Inc.
IR@modular-medical.com

Investor Contact

Valter Pinto, Managing Director
KCSA Strategic Communications
ModularMedical@KCSA.com

SOURCE: Modular Medical, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What ISO certification decision did Modular Medical (MODD) receive?

Modular Medical received a positive decision from its notified body regarding ISO 13485:2016 certification of its quality management system. The standard addresses medical device quality management systems, and certification demonstrates conformity through an independent audit within the certification's scope.

When does Modular Medical (MODD) target its CE Mark submission?

Modular Medical continues to target calendar year 2027 for its CE Mark submission. ISO 13485 certification is separate from CE marking, which requires additional regulatory review; the submission target is not an approval date.