Aesthetic pharmaceutical company Croma-Pharma has achieved European certification under the Medical Device Regulation (MDR) 2027/745 for product quality, patient safety and efficiency.
The company explains that it submitted all the necessary technical and clinical documentation over the course of the past year, which was reviewed by the notified body TÜV Süd and approved.
The Saypha RICH is the first of seven Croma-Pharma product groups to successfully complete the strict MDR certification process. All other products from the Saypha range will be approved by the first quarter of 2024, explains the company.
The MDR approval brings numerous advantages to patients and healthcare professionals including aesthetic indication, labelling, trackability of product, clinical evidence and safety requirements.
Andreas Prinz, managing director of
Croma-Pharma, said, “Croma-Pharma is setting standards in the field of
aesthetic medicine with the MDR approval of our dermal fillers. We are proud to
comply with the strict requirements of the new EU Medical Devices Regulation.”