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- Title
Die Laborverantwortung für die Sicherheit und Leistung der Prothetik: Aktuelle EU-MDR-Regularien zu ausgelagerten Prozessen bei Sonderanfertigungen.
- Authors
STOK, ARJAN J. H.
- Abstract
The article deals with the current EU MDR regulations for outsourced processes in dental technology. The digitization and specialization in dental technology lead to a variety of materials and techniques, which puts laboratory managers in the position of deciding whether to procure technologies or outsource processes. The EU MDR sets clear requirements for manufacturers of custom-made devices and their suppliers, including the implementation of a quality management system and the selection and monitoring of suppliers and subcontractors. Dental laboratories must provide a declaration stating the necessary data for product identification in order to certify compliance with safety and performance requirements. Dental laboratories are responsible for the selection and monitoring of materials and suppliers, as well as recording the safety and suitability of prosthetics. The decision to outsource manufacturing or service processes is at the discretion of the laboratory, but does not change the overall responsibility of the laboratory.
- Subjects
DENTAL technology; MEDICAL equipment safety regulations; PROSTHETICS; DENTAL equipment; MANUFACTURING processes; DENTURES; TOTAL quality management; DENTAL laboratories
- Publication
Quintessenz der Zahntechnik, 2022, Vol 48, Issue 6, p604
- ISSN
0340-4641
- Publication type
Article