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.