Which Standards can be applied? – 哪些标准可以应用？
| The EU standards and the Medical Device Directive define the basic requirements concerning the safety of medical devices. The technical specification is carried out within harmonized standards. These are developed by European standards organizations (CEN, CENELEC) and published in the EU Gazette and implemented in national laws – in Germany it is under the auspices of a DIN Deutsches Institut für Normung.
If you, as a manufacturer, meet all the applicable harmonized standards, it is assumed that the requirements of the directive are met in all these articles which are regulated by the respective standards. The implementation of standards is not mandatory. But in the case of not implementing them, it has to be proven in another way that the medical devices comply with the standards. |