The BEMER Classic and Professional sets have been given the CE marking pursuant to the EU directive 93/42/EEC for medical devices.
The main purpose of this marking is to guarantee consumers safe products within the European Union and it functions more or less as a “passport” for the European market.
By affixing the CE marking, the manufacturer confirms that the product in question complies with the specific EU directives.
In order to obtain the CE marking for medical devices such as the BEMER Systems, several conditions have to be met, including the following:
- The product must have a proven medical benefit.
- The product must have been proven to be safe for the patient, user, and third parties and remain so during use. No deterioration may arise during the entire life cycle of the product.
- The product must comply with all applicable legal requirements.
- The manufacturer is monitored by the responsible authority.
- Extensive “technical documentation” is required to verify compliance with all applicable requirements.
- The manufacturer is obligated to conduct market studies.
With respect to the BEMER Classic and Professional sets, BEMER International AG has flawlessly complied with all of these conditions and it will continue to do so.
For the BEMER Group as well as its customers, this yields the following benefit:
- The CE marking can be viewed as a seal of quality and is recognized not only in Europe, but in many other countries as well.
- This marking again emphasizes the medical quality of BEMER Systems and allows it to become increasingly established in the international market.
This statement can be viewed on www.bemergroup.com, from where it has been sourced. Grammar has been amended.