Modular Medical Receives Positive Notified Body Decision on ISO 13485:2016 Certification
Modular Medical has received a positive notified body decision concerning certification of its quality management system under ISO 13485:2016. The company says this is separate from CE marking and continues to target a submission in calendar year 2027.
Modular Medical, Inc. (NASDAQ:MODD) said it has received a positive decision from a 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).
The announcement concerns the San Diego-based medical device company’s preparations for the commercial launch of its Pivot tubeless patch pump and its regulatory plans for European markets.
ISO 13485:2016 is an internationally recognised standard for quality management systems used by medical device manufacturers. Modular Medical said certification would indicate, following an independent audit, that its quality management system meets the applicable requirements within the scope of certification.
The positive notified body decision does not represent a CE mark for Pivot. Modular Medical said ISO 13485 certification is a separate process from CE marking, which requires additional regulatory review.
#CE Mark submission targeted for calendar year 2027
Jeb Besser, Modular Medical’s chief executive officer, described the decision as another milestone in the company’s preparation for a CE Mark submission. The company continues to target that submission for calendar year 2027.
Modular Medical said there can be no assurance that it will obtain a CE mark on its anticipated timeline or at all. 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.
Modular Medical identified risks involving the timing of issuance of its ISO 13485:2016 certificate and its ability to maintain the certification. It also cited the timing and outcome of the planned CE Mark submission, any related notified body review, and its ability to obtain CE marking and commercialise the Pivot insulin delivery system in the European Union.
Other risks identified by the company include the development of its proprietary technologies, market acceptance, anticipated consumer demand, high-volume manufacturing, and general economic, industry or political conditions in the United States or internationally.
Modular Medical describes itself as a commercial-stage medical device company developing insulin delivery technologies intended to simplify diabetes management and increase access to insulin pump therapy.
The company says its Pivot tubeless patch pump is designed for people requiring intensive insulin therapy. Pivot was developed to address barriers that have limited wider adoption of insulin pump therapy among patients managing diabetes with multiple daily injections.
Modular Medical announced on October 27, 2026 that it had 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).
Modular Medical announced the decision on October 27, 2026. It relates to certification of the company’s quality management system under ISO 13485:2016 within the scope of certification.
ISO 13485:2016 is an internationally recognised standard for medical device quality management systems. The company says certification demonstrates, through independent audit, that its quality management system conforms to the applicable requirements of ISO 13485:2016 within the scope of certification.
No. Modular Medical says ISO 13485 certification is separate from CE marking, which requires additional regulatory review, and the announcement concerns a positive notified body decision regarding the quality management system certification.
Modular Medical continues to target its CE Mark submission for calendar year 2027, according to Chief Executive Officer Jeb Besser. The company says there can be no assurance that it will obtain a CE mark on that anticipated timeline or at all.
If obtained, a CE mark under MDR requirements would allow Modular Medical to pursue commercial distribution of its Pivot insulin delivery system across the EU, subject to satisfying all applicable regulatory and operational criteria.
Modular Medical identified risks including the timing of issuance of its ISO 13485:2016 certificate, its ability to maintain certification, the timing and outcome of its planned CE Mark submission and related notified body review, and its ability to obtain CE marking and commercialise Pivot in the European Union. The company also cited risks relating to technology development, market acceptance, consumer demand, high-volume manufacturing, and general economic, industry or political conditions.
Jeb Besser, Modular Medical’s Chief Executive Officer, said the positive decision represents another important milestone in the company’s preparation for CE Mark submission. He also said it underscores the company’s commitment to bringing diabetes technology to European markets.
Modular Medical is a commercial-stage medical device company focused on developing insulin delivery technologies designed to simplify diabetes management and increase access to insulin pump therapy. The company is preparing for the full commercial launch of its next-generation Pivot tubeless patch pump.
Modular Medical says Pivot is designed to provide a user-friendly, flexible and accessible approach to insulin delivery for people requiring intensive insulin therapy. It was developed to address barriers that have limited broader adoption of insulin pump therapy among patients managing diabetes with multiple daily injections.
Modular Medical’s shares trade on Nasdaq under the ticker symbol NASDAQ:MODD.
Modular Medical continues to target a CE Mark submission for calendar year 2027. Any related notified body review, CE marking and commercial distribution would remain subject to the applicable regulatory and operational criteria described by the company.