Both dental laboratories and practice laboratories or dentists with chairside production manufacture medical products and must therefore integrate a risk management or quality management system. The aim is the traceability of the products used. Dental laboratories certified according to DIN EN ISO 13485 (2016) already work mostly according to the MDR.
The goal of complete traceability is achieved by implementing technical documentation. The technical documentation is indispensable in the manufacture of medical devices and must be prepared in accordance with the MDR. The content of the technical documentation is regulated in Annexes II and III of the Medical Devices Regulation (EU) 2017/745.