Häufig gestellte Fragen
Is a standard ERP sufficient for a dental laboratory?
Generally not, because central functions such as BEL II and BEB billing, custom-made device documentation under the MDR and precious metal management are missing from generic ERP systems. These requirements are predominantly covered by dental industry-specific ERP solutions that natively maintain the service catalogues and update them regularly. A generalist can in theory be extended via customising, but the effort for the continuously updated billing catalogue versions and compliance obligations is usually higher than using a specialised system. The concrete need depends on laboratory size, depth of manufacturing and the share of statutory versus private care.
How does a dental technology ERP distinguish billing under BEL II and BEB?
BEL II is the nationally uniform catalogue of services for those with statutory insurance and functions as a maximum price list, whose nationwide average prices are set annually between the GKV-Spitzenverband and the Association of German Dental Technicians' Guilds (Verband Deutscher Zahntechniker-Innungen) and negotiated regionally via the Associations of Statutory Health Insurance Dentists (Kassenzahnärztliche Vereinigungen). The BEB, by contrast, is not a state-mandated price list but a non-binding calculation basis for private dental services with a considerably larger range of individual items. A dental ERP separates both logics automatically, assigns items to the respective insurance status and keeps track of the annually updated, regionally differing maximum price versions. In this way, material surcharges, additional patient payments and consumption recording can be documented consistently per item.
Which MDR obligations must an ERP for dental prostheses cover?
Since 26 May 2021, the EU Medical Device Regulation (MDR 2017/745) has applied, under which dental laboratories are classified as manufacturers of custom-made devices. For each custom-made device placed on the market, a declaration of conformity in accordance with Annex XIII must be drawn up, supplemented by a risk management system and end-to-end batch traceability of the materials used. A modern dental technology ERP automates the creation of this declaration per order, links it to the material batch and archives the records in a revision-proof manner with an audit trail. UDI carrier labelling and registration in the EUDAMED product module do not apply to custom-made devices, but the documentation obligations for manufacturing and the registration as an actor in EUDAMED remain unchanged.
Which risk classes do typical laboratory products fall into and what does that mean for the software?
Temporary restorations and splints are generally classified as Class I, permanent dental prostheses such as crowns and bridges as Class IIa, and dental implants as Class IIb. The class determines the documentation and conformity effort, which is why an ERP should store the risk class per order type and trigger the appropriate mandatory steps. For implantable devices, extended retention periods also apply: the declaration of conformity must generally be kept for at least ten years, and for implantable medical devices at least fifteen years after placing on the market. The system should therefore control timely, class-dependent archiving automatically instead of managing it manually.
How does a dental technology ERP integrate the digital CAD/CAM workflow?
In digital laboratory operations, patient cases arrive as datasets from the dental practice, usually in STL or PLY format from intraoral scanners, and are further processed in CAD software such as exocad or the 3Shape Dental System. A well-integrated ERP takes these datasets into the order, links them to order status, material flow and employee times, and passes them on to the CAM stage for the milling machine or 3D printer. Data exchange with the practice runs via cloud portals or direct interfaces depending on the manufacturer, so that orders can be accepted without media discontinuity. What matters is the clean assignment of scan data to the conformity and batch documentation, so that the digital workflow does not break the MDR verification obligations.
What does an ERP project for a dental laboratory realistically cost?
There are no reliable flat rates, since costs depend heavily on laboratory size, number of users and depth of integration; as a rough orientation, total costs in the mid five-figure to low six-figure range over five years are frequently cited for a laboratory with around ten workstations. Pure licence fees typically account for only around a quarter to a third of this, with the larger part going to implementation, customising, training and data migration. MDR- and QM-specific add-ons as well as accompanying consulting cause additional effort that should be budgeted in advance. Cloud models lower the initial investment but permanently shift expenditure into ongoing operating costs, which is reflected in the TCO analysis.