CE marking – Medical technology
The CE marking of our products demonstrates that MedTec’s MBST products are completely conform with legal regulations. Depending on the respective risk classification of the medical device, a Notified Body must be involved, whose identification number is also stated on the CE marking. The fulfilment of all requirements is proven in a conformity assessment procedure.
Importance of the CE marking for medical devices
The CE marking ensures that risks and side effects are analysed, assessed and minimised. The biocompatibility is guaranteed and risks of infection are reduced or eliminated. Mechanical, electrical and electromagnetic safety is ensured and the instructions for use are checked for completeness and comprehensibility. In addition, the medical devices are clinically or diagnostically assessed to make sure that the stated product characteristics and specifications regarding therapeutic or diagnostic benefit are met. Both the manufacturer and the medical device are monitored during the entire product life cycle.
MBST magnetic resonance therapy devices are CE marked
The CE marking may only be put on MBST magnetic resonance therapy devices if the extensive legal requirements are fulfilled. The marking therefore stands for comprehensive safety, performance ability and thus for the externally (neutrally) tested quality of our products.
Conformity assessment procedures
The technical documentation is assessed by the various specialists of the Notified Body and the clinical documentation by independent, experienced physicians of the Notified Body. On the basis of this certificate of conformity and the certificates for the quality management system, MedTec Medizintechnik GmbH generates the declarations of conformity for the MBST products. The declaration of conformity is the prerequisite for attaching the CE marking and thus for market placement of medical devices in the European economic area and possibly in EU third countries.
Class IIa medical devices
According to the definition of the Medical Devices Act (§ 3 MPG), medical devices are "all instruments, apparatus, appliances, software, substances or preparations made from substances or other articles, used alone or in combination, including the software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for the medical device's proper application, intended by the manufacturer to be used for human beings, by virtue of their functions".
Unlike drugs, medical devices mainly have a physical effect. The benefits of MBST medical devices are part of the approval procedure (assessment of conformity). This ensures that our MBST medical devices fulfil their intended purpose. The main focus here is proving the safety and performance of MBST products.
Protection and well-being of the patient are MedTec’s top priority. The regulatory system for medical devices has proven itself for many years. MBST medical devices are safe, efficient and effective.