The mjn-neuro project was born with two main objectives. The first is to develop a technological solution to help people with epilepsy improve their quality of life. The second, to work towards reducing the stigma that epilepsy still carries in society.

Today we are going to talk about our first objective and the important milestone we have just achieved.

When we started to develop our product, more than 8 years ago, we always knew that the design, manufacturing, safety tests, etc. had to meet a high level of quality.  For that reason, we defined that it needed to be a medical device and that it needed to accomplish all the existing regulations for medical devices.

In Spain, the certificates required for a medical device to meet current regulations are three:

  • The ISO 13485:2016 certificate. This international standard specifies that mjn-neuro meets the requirements for providing medical products and services.
  • The manufacturer’s license from the Spanish Agency for Medicines, AEMPS. This national standard authorizes mjn-neuro as a manufacturer of medical devices.
  • Medical device CE certificate. This European standard indicates that the solution developed by mjn-neuro to evaluate the risk of epilepsy seizures is a medical device that complies with directive 93/42/EEC.

Obtaining the CE certificate is one of the most important milestones that our project has achieved

Since 2019 we possess the ISO certificate and the license from the AEMPS. But obtaining the CE has been a much more laborious process for us as it has put to test from the beginning of the development of our solution, how we have designed it, how we have manufactured it, how we have tested it, that the use is safe for people, its operation and a very long etcetera.

The entire mjn-neuro team has worked very hard to obtain the CE. Especially David Blánquez (CEO and technical manager of mjn-neuro), Xavier Raurich (operations manager), and Fernando Atienza (quality manager).

Therefore we are very happy to inform you that since April 30th our epilepsy support solution has the CE certificate as a medical device.

It has been a long and complex process since the requirements by the certifying organization are extremely strict, and the hours dedicated by the team members have been endless. In our case, the notified body that has evaluated us has been the prestigious international company BSI.

Obtaining the CE certificate is one of the most important milestones that our project has achieved and opens the door for us to fulfill our main objective: That our solution becomes a reality to help so many people with refractory epilepsy in Spain and around the world.

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Save the date

The next Saturday 21st of November at 4 pm, you will be able to know first hand our product: mjn-SERAS.
mjn-SERAS is a healthcare product that sends a warning signal when the risk of epileptic seizures is high, to the affected person and their trusted contacts.

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    mjn-SERAS is a medical device with CE marking according to the European Directive 93/42/EEC and the Royal Decree RD. 1591/2009.
    Contraindications: Do not use the product if you suffer from an infection in the ear canal or if you suffer from a skin lesion in the vicinity of the product's area of influence.
    Considerations: This medical product works with an APP only on Android phones. The results tested are 96% sensitivity and 94% specificity.
    CPSP20103CAT.

    Save the date

    El próximo sábado 21 de noviembre a las 4 de la tarde, podrás conocer de primera mano nuestro producto: mjn-SERAS.
    mjn-SERAS es un producto sanitario que lanza una señal de aviso cuando el riesgo de crisis de epilepsia es elevado, a la persona afectada y a sus contactos de confianza.

    ¡Inscríbete!

      mjn-SERAS es un producto sanitario con marcado CE conforme a la Directiva Europea 93/42/EEC y el Real Decreto RD. 1591/2009.
      Contraindicaciones: No usar el producto en caso de padecer una infección en el canal auditivo o en caso de padecer una lesión cutánea en las proximidades del área de influencia del producto.
      Consideraciones: Este producto sanitario funciona con una APP solo en teléfonos Android. Los resultados testeados son 96% de sensibilidad y 94% de especificidad.
      CPSP20103CAT.