Large parts of the supply of medical aid are provided by service providers in the healthcare trades and healthcare system. On the one hand, the traditional healthcare trades are addressed here as manufacturers of medical devices (customised products). Here, there is an obligation to introduce and maintain a QM system in accordance with Article 10 of the MDR. For other service providers, such as rehabilitation technology companies or medical supply retailers, certification makes sense due to the legal requirements for processes and products.
Service providers in the healthcare sector also have a quality assurance obligation under the German Social Code. The introduction of QM systems has therefore become established in facilities such as pharmacies or care services. The increasing obligations to provide evidence to patients and cost bearers, as well as the often close co-operation between different service providers involved in patient care, have reinforced this development.
EN ISO 13485 has established itself as the gold standard in the healthcare provider environment, for example in the medical supply trade, healthcare businesses or service providers, provided that medical devices are the subject of the activities. In the general healthcare sector, on the other hand, the use of the international standard EN ISO 9001 is established.

Prequalification is an examination of the suitability of service providers in the area of the provision of medical aid and nursing aid. Prequalification is carried out at the request of the service provider by mdc as a prequalification body accredited by the German Accreditation Body (DAkkS).

The prequalification of medical and nursing aid is only relevant for the German market.