The Medicines and Healthcare products Regulatory Agency (MHRA), the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe, has stated on 26th June of 2013 that TedCas products are not considered medical devices under the European Directive.

Tore Johansen, Regulatory Affairs Manager:
"If a product has a medical purpose, i.e. it is specifically intended to provide or assist with the diagnosis, monitoring, prevention or treatment of a medical condition, it is likely to be a Medical Device under the Medical Devices Directive (MDD) 93/42/EEC. A Medical Device is defined in Article 1 clause 2(a) of the MDD. This will not only depend on the function of the device itself, but also on the claims made for its intended use in the accompanying documentation. Medical Devices are required to be CE-marked to indicate compliance with the Directive.

Software systems that are only intended for archiving/retrieving patient records/images are not normally considered to be Medical Devices. We also consider hospital patient records to fall into this category. If the software carries out further calculations, enhancements or interpretations of patient data, we consider that it will be a Medical Device. If it carries out complex calculations possibly involving the use of an algorithm, which replaces the clinician’s calculation and which will therefore be relied upon, then it will be considered a Medical Device."

TedCas Touch-Free interfaces does not replace the conventional computer user interface (mouse & keyboard) since they remain functional; rather the TedCas software provides an alternative, optional, touch-free user interface for accessing healthcare systems functionality.

TedCas software does not itself perform any action on DICOM image data, nor does it add any new data processing or data analysis functionality to the existing commercially available viewers with which it is designed to work. The software allows purely for touch-free user input to access the functionality of the commercially available viewers software.