Since last August, MOWOOT, the non-invasive, non-pharmacological solution to constipation without adverse effects, has CE certification as a Class IIa medical device.
The CE marking guarantees that the equipment marketed complies with the essential requirements of the mandatory legislation. These requirements include tests for electrical safety, electromagnetic compatibility and usability, among other factors.
The prestigious notified body BSI (British Standards Institution) from England is the competent authority that has granted the CE mark necessary to market a product in the European Union. The applied standards are even stricter when it comes to medical devices, as they require a more intensive testing process.
The CE certification process is the main concern of the entrepreneurs in the health sector, as was evident in the conference on prototyping and validation of medical devices organized by Biocat and the association of health-related companies CataloniaBio in May, which also counted with the participation of Markus Wilhelms, CEO of usMIMA, the company that developed MOWOOT.
In the case of MOWOOT, the process for obtaining the CE certificate took half a year, from the first laboratory tests and development of technical documentation to implementation of the quality management system and various certification audits by BSI.
CE Certification: guarantee of safety and effectiveness
The classification of medical devices is based on the potential risks involved in their use. The risks are determined by combining several criteria such as the duration of contact with the body, invasiveness and local effect against systemic effect.
MOWOOT, given its characteristics, is included among the medical devices class IIa, which are those that are considered of moderate risk and are subject to special controls in the manufacturing stage to demonstrate their safety and effectiveness, such as MRI systems or electrical stimulators.
MOWOOT is a wearable medical device comprising a massager belt and a control console. Once placed on the abdomen and implemented, the belt stimulates the region of the ascending and descending colon, to combat chronic constipation. Obtaining the CE certificate guarantees the safety and effectiveness of MOWOOT.
“In Spain there are few specialists in the field of medical devices, but it has been first priority for MOWOOT to enlist the help of a team of senior advisers with wide experience in this field”, says Marc Benet, the responsible quality manager of MOWOOT. “Thanks to many hours of intensive work and the support of a freelance consultant and Antares Consulting we have achieved this important milestone.”
The usMIMA team, who have designed and developed MOWOOT, wishes to thank Luca, Manuel and Maria at BSI, as well as Dr. Manuel Guerrero as an external consultant on regulatory issues, and Dr. Yehuda Zichermann as general advisor of MOWOOT.