The ruler is a class 1 medical device classified by the BfArM and registered with the German Medical Devices Information and Database System (DMIDS) according to § 3 MDR.
According to the Medical Device User Reporting and Information Ordinance (MPAMIV), both the manufacturer and the user are obliged to report incidents related to the use of the medical device.
Definition: “An incident is a malfunction, failure, or change in characteristics or performance, or an inadequacy in the labeling or instructions for use of a medical device that has resulted, may have resulted, or could result, directly or indirectly, in the death or serious deterioration of the health of a patient, user, or other person.”
To report incidents, please contact the manufacturer (see above) or the Federal Institute for Drugs and Medical Devices(www.BfArM.de).
As a class 1 medical device, the ruler was approved according to § 6 para. 1 MDR tested by the manufacturer according to the EC conformity assessment procedure and provided with a CE seal. All recommendations made on the ruler are in accordance with the currently valid guidelines or recommendations and/or manufacturer’s specifications. Details in this regard are available from the manufacturer.
Registered design No 002909382-0001, Office for Harmonization in the Internal Market – OHIM.