Koru Pharma has confirmed that Avalon Fine and Avalon Vital, have been awarded the CE MDR mark, signifying full compliance with the European Union’s Medical Device Regulation (MDR 2017/745). The certification authorises these products to be marketed and distributed throughout the European Economic Area (EEA).

What the CE Mark Represents

The CE mark (Conformité Européenne) is the European symbol of conformity, demonstrating that a product meets the EU’s rigorous standards for safety, health, and performance. For medical devices such as dermal fillers, CE certification confirms that the product has undergone comprehensive evaluation and can be trusted by practitioners and patients alike.

Avalon’s Milestone in Safety and Quality

This achievement underscores Koru Pharma’s commitment to innovation, reliability, and patient safety. Avalon Fine and Avalon Vital are designed to deliver natural and consistent aesthetic outcomes while meeting the highest European safety standards.

Meanwhile, CE certification for the rest of the Avalon dermal filler portfolio — Avalon Fine Plus, Avalon Vital Plus, Avalon Ultra Plus, and Avalon Grand Plus — is currently in progress, with approval expected in the near future. This upcoming milestone will further reinforce the Avalon range as a complete, CE-certified dermal filler solution for clinics and distributors across Europe.

Benefits Across the Value Chain

For Practitioners

• Confidence in offering CE-certified fillers backed by EU medical device regulation.

• Assurance of safety and performance through independent assessment.

• Stronger trust from patients when recommending Avalon treatments.

For Patients

• Peace of mind knowing treatments use fillers certified under stringent European standards.

• Reduced risks due to comprehensive safety and quality testing.

• Reliable and natural-looking results from CE-marked products.

A Trusted Future in Aesthetic Medicine

With CE marking already achieved for Avalon Fine and Avalon Vital — and certification for the remaining fillers in progress — Koru Pharma reinforces its position as a trusted provider of dermal fillers in Europe. This milestone ensures practitioners, patients, and distributors alike can rely on Avalon fillers as safe, effective, and high-quality medical devices.