Software & Apps - to be a medical device or not Introduction Author - Arild R. Hansgård Date - 18 November 2018 1

History Different applications Definitions Key Words Guidance documents

History 1992 1993 1994 2006 2007 2009 2011 2017 MDD 93/42/EEC Am. Directive 2007/47 / EC enter into force. MDR enter into force PACS deployed at Army Clinics in the USA. DICOM-standard introduced First smartphone on the market in the USA Nokia IPhone First stand alone SW certified by Nemko First mobile app certified by Nemko 3

Different applications Fitness - Rehabilitation purposes - Various aids for people with disabilities - Calculating medicine doses to take/inject - Diagnosis - Programs to support decision-making 4

Definitions Software: “software” may be defined as a set of instructions that processes input data and creates output data. Stand alone software: ‘stand alone software’ means software which is not incorporated in a medical device at the time of its placing on the market or its making available. Software as a medical device: Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. Definitions

Stand alone software is considered to be an active medical device. Active therapeutical device: Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap. Active device for diagnosis: Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. Definitions

Key Words Mode of action, Intended use and Medical Purpose Software for general purposes when used in a healthcare setting is not a MD Do the SW perform an action on data not limited to storage, archival, communication and simple search? Is the action directly for the medical benefit of individual patients? Do the description of purpose harmonize with the description of the purpose as given under the definition of medical devices, in the Directive. Medical Indications always have to be supported by adequate clinical data

Guidance documents MEDDEV 2.1/6 July 2016 MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.17 (09-2015)