Logo PTB
symbolic picture: scientific-technical publications

Publications on the Medical Devices Act

These guidelines are the translation of the German „Leitfaden zu messtechnischen Kontrollen von Medizinprodukten mit Messfunktion (LMKM)“. The document describes the correct metrological verification of several medical devices with a measuring function. The present translation has no other purpose than to inform about the requirements in Germany and may serve as a technical resource for interested parties in the field. While in Germany, the original document has a certain legal relevance, the translation has no legal status, neither inside nor outside Germany.

We recommend that any person or institution carrying out metrological verifications on medical devices according to the provisions of the Medizinprodukte-Betreiberverordnung (Medical Devices Operator Ordinance) read the Leitfaden zur messtechnischen Kontrolle von Medizinprodukten mit Messfunktion (Guidelines for metrological verifications of medical devices with a measuring function – LMKM).

To ensure the uniform implementation of the regulations on metrological verifications of medical devices with a measuring function according to the provisions of the Medizinprodukte-Betreiberverordnung, the use of these guidelines is recommended to verification authorities and all other persons and institutions carrying out such metrological verifications. In its 3rd version, that is currently available, the guidelines were elaborated by the editors after consultations with the relevant parties. Part 1 addresses audiometers, thermometers, non-invasive sphygmomanometers, ocular tonometers and ergometers; Part 2 is dedicated to therapy dosimeters and dosimeters for radiodiagnostics.