Our Medical Devices Comply with MDR 2017/745
Herb-Pharma AG has successfully completed the certification process under the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR).
Our products thus meet the strictest European requirements for the safety, performance, and quality of medical devices.
Product Certifications
Based on the assessment by the Notified Body 3EC International a.s., NB 2265, the following medical devices have been successfully certified under the MDR:
- fytofontana VIROSTOP – oral spray, nasal spray, and lozenges (Class IIa medical device)
- fytofontana GYNTIMA – vaginal suppositories (Class IIb medical device)
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VIROSTOP – EU Quality Management System Certificate No. 2024-MDR/QS-023/A
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GYNTIMA – EU Quality Management System Certificate No. 2025-MDR/QS-003
In the Process of MDR Certification
The medical devices under the brands AURECON (ear drops and sprays) and HEMORRELAX (rectal cream and suppositories) are already in the MDR certification process.
The Notified Body 3EC International a.s. has confirmed the receipt of the formal application, the signing of a written agreement, and is performing appropriate surveillance in accordance with Regulation (EU) 2023/607, which governs the transitional provisions for medical devices under the MDR system.
These products are therefore placed on the market in full compliance with the current European legislation and are duly monitored under the agreements concluded with the Notified Body.
Quality Management System according to EN ISO 13485:2016
Herb-Pharma AG also holds a quality management system certificate according to the EN ISO 13485:2016 standard, issued in accordance with Regulation (EU) 2017/745 on medical devices (MDR).
This certificate confirms that the design, development, and manufacturing processes of our medical devices meet internationally recognized quality standards and are in full compliance with MDR requirements.
Why This Is Important
Thanks to these certifications, our medical devices can continue to be legally placed, distributed, and sold on the market in the countries of the European Union.
For our partners and customers, this is a guarantee that every Herb-Pharma AG product is created in compliance with European legislation, under a strict quality management and control system, and with an independent assessment by a Notified Body.
