Ionclinics achieves certification CE1936 – Regulation 2017/745 (MDR)

• The CE1936 certification granted by TÜV Rheinland Italia certifies that a medical device meets the essential requirements defined in Regulation (EU) 2017/745 (MDR) on medical devices. This regulation establishes a detailed and stringent regulatory framework to ensure the safety, performance, and quality of medical devices before their commercialization in the European Economic Area (EEA).

On September 16th, 2024 – TÜV Rheinland Italia, Represented by Vagner Rodrigo Lima, Local Field Manager IBERICA of the Medical Devices, delivered to Victoria E. Gonzalez QA&RA Director of IONCLINICS the CE1936 certificate in accordance with the new EU Regulation 2017/745 for EPTE devices in their models EPTE System and HOME tDCS.

Ionclinics is a company located in Valencia, Spain, and its goal is to provide health solutions to society through the comprehensive and cross-disciplinary application of neuromodulation, and to democratize access to these advanced treatments.

Victoria E. González, Director of QA&RA (Quality Assurance & Regulatory Affairs) of Ionclinics, emphasizes the importance of offering products certified in accordance with the MDR, one of the most stringent regulations worldwide, which ensures the safety and efficacy of medical devices for healthcare professionals and their patients. "The quality, safety, and effectiveness of our products, from scientific evidence to clinical experience, is our way of understanding service to our clients since our inception," says González.

The certification process was marked by a multidisciplinary approach, involving collaboration among various technical experts, clinicians, and qualified personnel during the different steps of the process. All were engaged in analyzing the specifications to ensure the highest possible outcomes.

The achievement of this milestone was made possible thanks to the huge knowledge in the field from the multidisciplinary team that makes up Ionclinics and their cooperation through the process. Along with the intervention of TÜV Rheinland Italia and the high-profile technical professionals made available for the evaluations required by EU Regulation 2017/745 and UNI EN ISO 13485:2016, in respect of each other's roles, has led to the marketing of medical devices of important and high technological level.

The activities established between manufacturers and notified bodies strengthens our mission in the medical sector, which is to assess medical devices in compliance with Regulation 2017/745. “Obtaining certification in accordance with MDR signifies aligning one's products with one of the most advanced regulations in the industry. This ensures that safe and high-performing devices are available to the market, demonstrating a commitment to the evolving requirements for medical device safety“ says Vagner Rodrigo Lima. TÜV Rheinland reaffirm their professional qualities of competence, dedication, and meticulousness. They are fully aware of the significance of their work for both the community and the industrial sector, continuing to serve as a reliable and trusted reference point, in the evaluation of innovative and safe medical devices.