1. Alf Öhman, investigator, Läkemedelsverket/ MPA Sweden Stefan Visscher, senior inspector Software Working Group, Brussels, February 6 2015 Dental software as medical device Dutch

2. PACS (borderline & classification manual) 8.4. Picture Archiving and Communication Systems (PACS) 2 Type/ functionalityRisk class (a) PACS used for viewing, archiving and transmitting images.Rule 12: class I (b) Where the post-processing of the image for diagnostic purposes is such as: - image processing functions which alter the image data (e.g. filtering, multiplanar reconstruction, 3D reconstruction) - complex quantitative functions (e.g. arterial stenosis evaluation, ventricular volume calculation, calcium scoring, automatic indication (detection) of potential lesions). Rule 10: class IIa (if it does not directly influence the source device, though allows for direct diagnosis (c) With image enhancing by controlling image acquisition.Rule 10 or 11: class IIa or IIb

3. MEDDEV 2.1/6 c.1) Electronic Patient Record Systems Electronic patient record systems are intended to store and transfer electronic patient records. They archive all kinds of documents and data related to a specific patient. The electronic patient records themselves are not computer programs, therefore, they should not be qualified as a medical device i.e. an electronic patient record that simply replaces a patient’s paper file does not meet the definition of a medical device. The modules used with electronic patient record system modules that might be qualified in their own right as medical devices are for example: - an image viewer with functionality for diagnosis based on digital images; - a medication module. 3

4. Intended use Example 1 helps you to acquire, view, compare and measure all your images (x-ray, intra oral, color, and documents), from digital x-ray systems, or scanners for classical x-rays. The software is automatically activated from your patient administration program when you want to view images stored with the current patient. All patients' files can be opened from anywhere in a network. It contains several image enhancement functions as well as measurement tools to assist you in your daily work: For projections' errors, you can use the software's Endo-file measurements. To easier locate cavities between teeth, use digital subtraction. Example 2 is a very powerful, flexible, and easy-to-use PC/Windows software program for orthodontics and maxillofacial surgery. It can be used for visual diagnostic imaging and cephalometric analysis, as well as for treatment simulation with surgery prediction. It enables a quick and easy method to interactively plot the points required by the actual analysis, chosen among standard or custom-made cephalometric analyze methods. The points, or markers, are plotted directly on the X-ray image admitting immediate graphical feedback. Ready-made graphics for incisors, canines, premolars, and molars, as well as user-defined bone segments are interactively drawn and placed on the Xray. It automatically calculates accurate values for the measurements (distances and angles) defined by the chosen analysis. Further measurements can interactively be made directly on the on-screen radiograph, correctly calibrated. 4