At PTB, medical device activities are spread across different departments in both Berlin and Braunschweig. In order to coordinate these activities internally and at the same time to ensure targeted and efficient guidance for authorities, manufacturers, professional associations and testing offices, PTB has set up a coordination desk for medical devices.
The coordination desk has the following tasks and competencies:
- the scientific guidance of superior federal authorities, competent authorities and notified bodies
- PTB internal guidance concerning medical device legislation (MDD, MDR, MPG, MPBetreibV)
- the development, maintenance and publication of the Guidelines for metrological verifications of medical devices with a measuring function (LMKM)
- representing PTB in national (AGMP, DIN, EK-Med) and international (ISO, OIML) boards and committees
- consolidating the cooperation with international metrology institutes in the field of medical devices