Since 14th June 1998, Medical devices may only be marketed in the European Union, if the requirements of Directive 93/42/EEC (MDD) are met and the CE marking is affixed on the product. If necessary, additional requirements of the Member States must be complied with.
For Medical Devices
In Germany, the regulations of the National Medical Devices Act (MPG) should be applied to.
In order to meet the individual requirements of the industry and the different degrees of risks of the products, a system of hazard classes and modules of conformity has been established.
Depending on the module, a Notified Body for the product- and/ or system assessment should be turned to, e.g. DQS MED (identification number 0297). As a Notified Body, we are an authorized to perform MDD certification.
Flexible & Personalized Solutions
Here we find flexible and personalized solutions that are tailored to your individual requirements. Specifically, these are:
- Review of technical documentation in accordance with MDD Annex VII
- Conformity assessment procedures according to the Medical Device Directive Annex II, V and VI
- Transition to MDR 745/2017