Go-Pen receives CE Mark (Class IIb) for its user-fillable insulin pen – ready for global rollout
Danish medtech company Go-Pen ApS has received CE Mark approval in Class IIb under the EU Medical Device Regulation (MDR) for its user-fillable insulin pen, which is now approved for use with a range of commercial insulin formulations.
Lyngby, Denmark – 11 November 2025. The CE certification marks a major milestone for Go-Pen and provides the regulatory foundation for market registrations in a number of international markets, particularly in regions where syringes remain the dominant form of insulin delivery.
“The CE approval confirms that our user-fillable insulin pen meets the highest European standards for safety and performance,” said Ole Kjerkegaard Nielsen, CEO of Go-Pen ApS. “It also represents a gateway for market entry across multiple regions where patients still rely on syringes for insulin delivery – a practice we aim to replace with a safer, more dignified and affordable solution.”Medical experts and patients review Go-Pen®
"GO-Pen is the most innovative concept I have ever seen towards the needs of patients who take insulin using syringes," says Anne Peters, Professor at Keck School of Medicine, a diabetes specialist who directs diabetes centres in both Beverly Hills and underserved East Los Angeles.
The device has undergone rigorous physical, chemical and human factors studies to ensure its effectiveness and safety in diverse environments. User feedback has been positive, indicating GO-PEN®'s potential to improve diabetes management globally.
"I have just tried GO-PEN®, and I was very comfortable using it. It is going to be a very exciting product, and it will help many people with diabetes," says Nupur Lalvani, founder of Blue Circle Foundation in India, who has been living with type 1 diabetes for over 25 years and runs a non-profit organisation focused on diabetes awareness and advocacy.
Global market: 20 million syringe users
Globally, more than 20 million insulin users still inject using disposable syringes. Syringe reuse, dosing errors and needle-stick injuries remain widespread in low- and middle-income countries, leading to unnecessary health risks and significant healthcare costs. Replacing even a fraction of these with safer, refillable pens represents a market opportunity exceeding €1 billion annually, based on unit economics comparable to low-cost syringe sets. The Go-Pen provides a cost-competitive “syringe replacement”, designed to be filled directly from standard insulin vials — combining affordability with modern safety and usability.
In addition, Go-Pen can also be used to address the growing problem of insulin pump system failures, which affect many of the world’s 1.6 million insulin pump users, each typically experiencing 2–4 failures per year due to infusion occlusions, battery issues or electronic errors. These episodes often require an immediate alternative for insulin delivery to avoid hyperglycaemia or hospitalization. Assuming a conservative annual replacement pattern, this represents a secondary market of €200–300 million globally for simple, backup delivery devices. The Go-Pen offers a practical and instantly deployable solution for such situations, as it can be filled directly from existing insulin vials and used safely until pump function is restored.
Production and partnerships established
To support its international commercialization, Go-Pen has established manufacturing agreements with SP-Meditec in Helsingør, Denmark, and secured a global supply chain to ensure consistent, high-quality production and distribution. In parallel, the company has signed commercial development agreements with two global medtech manufacturers to further accelerate adoption and integration into key healthcare markets.
Following its FDA clearance earlier this year (May 2025), the CE mark completes Go-Pen’s dual regulatory foundation for the U.S. and European markets. The company has already signed a term sheet for its first commercial contract, has a full distribution contract under review in the U.S., and is in active negotiations with Ministries of Health in several countries facing syringe-related health challenges.
2026 rollout preparations
Go-Pen is currently raising new growth capital to scale production and global market entry. The company has already secured commitments from its first investors, including European institutional support, and remains open to additional participation.
“There is significant investor appetite for tangible global health impact opportunities,” added Ole Kjerkegaard Nielsen. “We offer an alternative to the volatility of the AI sector — a chance to invest in a proven, life-saving product that can transform diabetes care worldwide.”
The company expects to begin product rollout in 2026, with parallel commercialization efforts across Europe, the U.S., and selected emerging markets.
About Go-Pen ApS
Founded in 2019, Go-Pen ApS develops an affordable, user-fillable insulin pen designed to replace syringes for people with diabetes worldwide. By combining safety, simplicity, and cost-efficiency, Go-Pen’s mission is to make modern insulin delivery accessible to all.
Press Contact
Ole Kjerkegaard Nielsen, CEO
📧 ole@go-pen.com
🌐 www.go-pen.com
