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

What happened

Modular Medical said its notified body, designated under European Union rules, gave a positive decision on certifying its quality management system under ISO 13485:2016. The company targets CE Mark submission for its Pivot tubeless patch pump in calendar year 2027.

Confirmed

Global impact / market context

The quality certificate is a step toward European approval but is not the same as a CE mark, which still needs extra review. A successful CE mark would let the company sell Pivot in Europe, adding a possible new revenue source beyond its current markets.

Analyst inference

Modular Medical is a small commercial-stage device maker preparing a full launch of Pivot, so approval progress matters for its growth story. Investors weigh timeline risk because the CE mark filing is targeted for 2027 and approval is not guaranteed.

Analyst inference

What to watch

1. The company said it continues to target CE Mark submission for calendar year 2027, so watch whether that filing happens on schedule or slips. Confirmed
2. Watch for news that the CE mark review has started, since the quality certificate alone does not permit European sales. Analyst inference
3. Track the company's spending on the Pivot launch and regulatory work, because costs may rise before any European revenue arrives. Proposed

Evidence

• accessnewswire.com