**Abstract**

Biosensing systems based on microneedles can overcome the stratum corneum of the skin, i. e. the outer natural barrier of the human body, without any pain and detect the target analytes directly in the interstitial fluid. Moreover, microneedlebased devices (MNDs) can combine diagnostic sensing and therapeutic administration of drugs in one single tool. From this point of view, more than a painless door to the human body, a MND represents the a perfect example of theranostic instrument, since a single device could quantify the real value of a relevant biomolecule, such as glucose, and accurately deliver a drug, the insulin, if needed. MNDs could be integrated on printed circuit boards, flexible electronics and microfluidic channels, thus allowing a continuous monitoring of the physiological parameters with very low invasiveness, together with sustained and localized administration of drugs. MNDs can be designed for very specific applications, from the detection of skin cancer to the monitoring of metabolic pathways. Moreover, several fabrication approaches have been introduced, from laboratories to large-scale production. Finally MNDs can be properly functionalized to enhance analytical performances.

**Keywords:** microneedles, theranostics, biosensing, microfabrication, drug delivery
