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KORU Medical Systems Secures EU MDR Certification for Freedom60 Infusion Pump

17 Mar 2026
Admin
News Article

KORU Medical Systems Secures EU MDR Certification for Freedom60 Infusion Pump

A regulatory milestone is opening new doors for patient-friendly infusion therapy in Europe.

KORU Medical Systems has announced that its Freedom60 Infusion Pump has received certification under the European Union Medical Devices Regulation (EU MDR 2017/745), clearing the way for commercialization across the European Union.

What This Certification Means?

EU MDR certification is a critical requirement for medical devices entering the European market.

With this approval:

The Freedom60 Infusion Pump can now be marketed across EU countries
KORU expands its footprint in the growing home infusion therapy segment
Patients gain access to more user-friendly, flexible treatment options

A Closer Look at the Freedom Infusion Systems

KORU’s infusion portfolio is designed around simplicity and patient comfort.

Freedom60 Infusion Pump

Supports 50 mL prefilled syringes
Designed for larger volume subcutaneous infusions

FreedomEDGE Infusion System

Compatible with 20 mL prefilled syringes
Offers flexibility for smaller dosing regimens

Together, these systems provide:

Consistent and intuitive operation
Flexibility across different treatment needs
A unified experience for both clinicians and patients

Supporting the Shift Toward Prefilled Syringes

The certification comes at a time when prefilled syringe formats are gaining traction—especially in subcutaneous immunoglobulin (SCIg) therapy.

Why the shift? Prefilled syringes offer clear advantages over traditional vial-based systems:

Fewer preparation steps
Reduced medication handling
Lower risk of dosing errors
Decreased treatment burden
Improved patient independence at home

This aligns with a broader industry push toward decentralized, home-based care.

Improving the Home Infusion Experience

For patients requiring long-term therapies like SCIg, treatment isn’t occasional—it’s routine.

KORU’s systems aim to make that routine easier by:

Simplifying setup and administration
Reducing time spent on each session
Enabling more confidence in self-administration

The result: a more manageable therapy experience and improved quality of life.

What Leadership Is Saying?

Linda Tharby, CEO of KORU Medical Systems, highlighted the significance of this milestone:

The certification expands access to simpler, patient-focused SCIg delivery
Prefilled syringes are driving demand for low-complexity infusion solutions
The Freedom systems are designed to fit seamlessly into patients’ daily routines

The Bigger Picture

This approval reflects two larger trends in healthcare:

1. Rise of Home-Based Care

Patients increasingly prefer treatments that can be administered outside hospitals.

2. Device-Drug Integration

Therapies are being designed alongside delivery systems for better usability and outcomes.

Final Take

With EU MDR certification, the Freedom60 Infusion Pump and FreedomEDGE system are set to expand access to simpler, more flexible infusion therapy across Europe.

For patients managing chronic conditions at home, that’s not just convenience—it’s a meaningful upgrade in how care is delivered.