Article written by Fernando Atienza, MJN’s Quality Manager
From the beginning of development of our device to assess the risk of epileptic seizure, MJN was clear that MJN-SERAS should be considered a medical product according to the applicable regulation, Directive 93/42/EU and Regulation EU 745/2017.
The purpose of CE Marking, especially for a medical product, is the guarantee of safety and compliance with requirements of a product or service.
Obviously, these are two essential and non-negotiable characteristics since its objective is to help take care of people’s health:
The product must be totally safe; eliminating, controlling and minimizing the foreseeable risks regarding its own nature, in other words, all aspects in which the product may pose a risk to users must be absolutely controlled, including those derived from a malfunction or a breach of the tasks that the product claims to perform.
The Directive literally states that “products must be designed and manufactured in such a way that their use does not compromise the clinical condition or the safety and health of the users or, where appropriate, of other persons when used under the intended conditions and purposes”.
To guarantee the safety of the MJN-SERAS device, the MJN technical team has documented a strict risk analysis and has worked on an extensive documental clinical evaluation of the current state of science, together with the applicable studies established by the regulations harmonized for medical products.
The complete product technical documentation in accordance with applicable legislation and regulations is completed with the implementation of a strong quality management system, in accordance with ISO 13485. The certifying entity BSI Group, a Notified Body of medical products renown for its meticulous work, has just granted this certification to MJN definitively.
He has more than 11 years of experience in the medical technology sector, telecommunications and special facilities in hospitals. He is an Industrial Technical Engineer, in Industrial Electronics, and has a Master's degree in quality management systems for medical products.
His speciality is regulatory compliance and design and implementation of quality management systems for medical products with a special presence in technological devices, called Active medical devices. Fernando, also, is the author of the website www.productosanitario.es devoted exclusively to medical products and their requirements.
We have also recently obtained the Manufacturer’s License granted by the Spanish Agency for Medicines and Health Products (AEMPS).
Currently, and always under the supervision of BSI Group, MJN is working on obtaining the CE seal for medical devices as well as the manufacturer’s licence from the AEMPS (Spanish Medicines Agency). Obtaining these certificates will enable us to start commercializing MJN-SERAS, hopefully in a very short period of time.
With all this, the MJN Neuroserveis team continues working to put on the market a product that will undoubtedly make the daily life of patients with Epilepsy and their relatives easier, offering the highest level of safety and compliance with the requirements applicable to this product.