The certification body for the dental field

Nordic Dental Certification

Regulatory requirements according to the Medical Device Directive

Dental technical laboratories are defined as manufacturers of custom made medical devices according to the Medical Device Directive 93/42/EEC (MDD) and must therefore be able to provide documentation and keep records of relevant information in accordance with the require­ments in MDD to such manufacturers.

The laboratory must keep records on the production and other relevant documentation regarding the devices for at least five years. These records must include the name of the dentist, identification of the patient, and information on how the device was manufactured including material(s) used and their traceability. With each device there must also be a declaration that the device has been manufactured according to the provisions of MDD.

Dental technical laboratories thus need a quality system, assuring compliance to the MDD requirements. Dental technical labs are usually small or very small enterprises and the requirements for the necessary quality system may be adjusted according to the size of the lab.

The normative document on which this Nordic certification system for dental technical laboratories is based expresses the minimum requirements for a quality system for such laboratories to comply with the requirements of the Medical Device Directive (93/42/EEC).

 

 

Phone: +47 67 581530
Mobil (cell) phone: +47 90 11 61 36
Fax: +47 67 59 15 30
E-mail: ncert@ncert.no

Contact information:

Dental Technical Laboratories

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Postal address:

P.O. Box 70
N-1305 Haslum
Norway

Visiting address:

Kirkeveien 71 B
N-1344 Haslum
Norway