Positive Notified Body opinion under MDR for CT001
2025-02-04 · Cessatech A/S · original cessatech.com ↗
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. Release Related articles Releases 27. August, 2026 CT001 ready for shipment to initial U.S. hospitals as launch activities commence Initial U.S. commercial supply of CT001 now available for shipment Launch activities initiated with... Read more Releases 24. July, 2026 Proveca intends to request a re-examination of CHMP opinion for CT001/KemSu See also the updated Q&A documentation related to the Release: Link The European Medicines... Read more Releases 12. June, 2026 Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet, to advance an intravenous formulation of melatonin for post-anaesthesia delirium (CT004) in children ... Read more Stay up to date! Subscribe and get notified on Cessatech's latest news. An acceptance email will be sent to you, please check your spam. Please leave this field empty Almost there! Please check your inbox to confirm your subscription to Cessatech.
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