bonyf's products come under the definition of medical devices and thus either under the European Medical Products Directive (93/42/EEC). These Directives require a Quality Management System covering the manufacture and marketing of these products.

Responsibility for the QMS on medical devices in Risk Class I lies with the manufacturer exclusively. bonyf has also voluntarily handed over responsibility for monitoring the QMS quality certification organization, DEKRA under EN ISO 9001 / 12.2000 and EN ISO 13485 / 07.2003 (Quality Management Systems for Medical Devices).

A complete QMS (under EN / ISO 9001 / 12.2000) means that all departments, including Development, work in accordance with the generally accepted principles of quality management.

CE Labeling

As European law stands at present, Medical Devices have to have a CE-lable. This indicates on one hand that the product can be sold freely in the open trade throughout the European Economic Area, and on the other hand that the manufacturer has given a declaration to the effect that he meets the fundamental (quality) requirements for medical devices under European Medical Products Directive 93/42/EEC.

This Directive distinguishes between various classes of medical devices, categorized by risk level and required effectiveness; those in Class I represent the lowest degree of risk, those in Class III the highest.

Class I Medical Devices bear the CE lable, meaning that responsibility lies with the manufacturer. For the higher classes, the CE lable also has to bear the identification number of a “notified body”, a control organization which is registered with the European authorities in Brussels and carries out audits on the manufacturer and yearly monitors his production.

One Example of such a medical device is a disinfectant cleansing tablet, which is currently in production at bonyf and is a Medical Device Class IIa CE 0124.