CE marking
Since June 14, 1998, medical devices may only be placed on the market in the European Union if the requirements of Directive 93/42/EEC (MDD) are met and the CE marking is affixed to the product. If necessary, additional requirements must be met in the member states. In Germany, the regulations of the national Medical Devices Act (MPG) must also be applied. A system of hazard classes and conformity modules has been set up to take account of the individual circumstances of the industry and the different degrees of risk posed by the products. Depending on the module, a notified body may have to be involved for product and/or system testing, e.g. DQS MED (identification number 0297). As a Notified Body, we are authorized to carry out certification in accordance with the MDD. We find flexible and personal solutions that are specially tailored to your individual requirements. In detail these are
- Testing of technical documentation in accordance with Annex VII of the Medical Device Directive
- Conformity assessment procedures in accordance with Annex II, V and VI of the Medical Device Directive