Modular Medical Announces Positive Notified Body Decision on ISO 13485:2016 Certification
Key Highlights
- ➤Modular Medical received a positive notified body decision on ISO 13485:2016 certification.
- ➤Modular Medical targets CE Mark submission for calendar year 2027.
- ➤ISO 13485 certification remains separate from CE marking and requires additional regulatory review.
- ➤CE marking would enable EU commercial distribution, subject to regulatory and operational criteria.
Expert Statements
Jeb Besser, Chief Executive Officer of Modular Medical
“This positive decision represents another important milestone in our preparation for CE Mark submission, which we continue to target for calendar year 2027”
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.”
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."
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