Published: 4. February, 2025

On 4 February – Cessatech A/S (“Cessatech” or “the Company”) announces that the Company…

On 4 February – Cessatech A/S (“Cessatech” or “the Company”) announces that the Company has received a positive Notified Body Opinion under Article 117 of the Medical Devices Regulation (EU) 2017/745 (MDR) for its lead asset CT001. The technical documentation for CT001 was reviewed in accordance with Annex I of Regulation (EU) 2017/745. The assessment has been performed for the purpose of an initial application – and the objectives of this assessment were found to have been met. Technical documentation for the device is considered adequate to support compliance with the General Safety and Performance Requirements of the MDR.

The MDR opinion ensures medical devices with a drug component are safe and effective. The EMA reviews the drug part, while a Notified Body evaluates the device. Together, they ensure the product meets EU efficacy and safety standards.

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