Mapping Your Success 2013 BSI Healthcare Roadshow: Mobile Health Software, Mobile Phones and Telemedicine Under the EU Approach

Mapping Your Success 2013 BSI Healthcare Roadshow: Mobile Health Software, Mobile Phones and Telemedicine Under the EU Approach

Telemedicine & mhealth Definition of Telemedicine: Use of telecommunication and information technologies in order to provide clinical health care at a distance. (Source: www.wikipedia.edu) Definition of mobile health (mhealth): Practice of medicine and public health, supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as mobile phones, tablet computers and PDAs, for health services and information mhealth applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient vital signs, and direct provision of care (via mobile telemedicine). (Source: www.wikipedia.edu) When are mobile and other telemedicine devices and their software applications considered to be medical devices? 2

Directives, Standards, & Guidance Documents Directives - Mandatory Harmonized Standards* Non-harmonized Standards** Guidance Documents*** 93/42/EEC (MDD) 90/385/EEC (AIMDD) 98/79/EC (IVDD) EN ISO 14971 EN ISO 13485 EN IEC 62304 EN 60601-1 EN 62366 ISO/IEC 12207 EN IEC 61010-1 MEDDEV 2.1/6 IEC/TR 80002-1 NB-MED/ 2.2/Rec4 * Harmonized standards provide a presumption of conformity with the essential requirements of the directives. ** Use of non-harmonized standards can help provide compliance with directives. *** Guidance documents are agreed upon (by Competent Authorities, Notified Bodies, Industry, etc.) directive interpretations and if followed, ensure uniform application of relevant directive provisions Legally not binding 3

European Harmonized Standards Standard EN 62304 Topic Medical device SW SW lifecycle processes EN ISO 13485 Medical devices - Quality management systems Requirements for regulatory purposes EN ISO 14971 EN 60601-1 Medical devices Application of risk management to medical devices (Note: Normative reference in EN 62304) Medical electrical equipment General requirements for basic safety and essential performance Section 14: Programmable electrical medical systems (PEMS) (Note: Not harmonized to IVD Directive) EN 62366 Application of usability engineering to medical devices 4

International Guidance Guidance MEDDEV 2.1/6 (2012) IEC/TR 80002-1:2009 Topic Guidelines for the qualification and classification of standalone SW used within healthcare within the regulatory framework of medical devices Medical device SW - Part 1: Guidance on the application of ISO 14971 to medical device SW NB-MED/2.2/Rec4 SW and Medical Devices (2001) Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices Picture Archiving and Communication Systems (PACS) is included 5

MDD 93/42/EEC M5 (2007/47) Changes 1. Article 1: Change of Definition of Medical device - medical device means any instrument, apparatus, appliance, software, material or other article 2. New sub-clause ER 12.1a: For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification. 3. Annex IX Active Medical Device definition in the classification criteria added Stand alone software is considered to be an active medical device. 6

Definition of Accessory An article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device. 7

Medical Device Classification Directive Classification Accessory AIMD Directive All AIMDs are one classification (considered high risk) All AIMD accessories are given same high risk classification MD Directive Rule-based Accessories are classified in their own right IVD Directive List, not rule-based (List A - high -or- List B - moderate risk devices) Accessories are classified in their own right * If SW is embedded in a medical device, it takes on the classification of the medical device * 8

Classification of stand alone software (Annex IX 93/42/EEC) Definition: Stand alone software is an active device Non invasive devices Invasive devices Additional rules applicable to active devices Special rules Rules 1 to 4 Rules 5 to 8 Rule 9 Rule 10 Rule 11 Rule 12 Rules 13 to 18 Applicable active device rules 9

Classification of stand alone SW(Annex IX) Rule # Summary Classification 9 All active therapeutic devices intended to administer or exchange energy 10 Active devices intended for diagnosis 11 Active devices to administer or remove medicines, body liquids, or other substances 12 All other Active Devices ( fall through rule) Class IIa unless potentially hazardous way then Class IIb Class IIa or Class IIb (e.g. ionizing radiation) Class IIa unless potentially hazardous way then Class IIb Class I Annex IX, 2.3: SW which drives a device or influences the use of a device, falls automatically in the same device class. 10

MEDDEV 2.1/6 GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES 2013 Medical Device Roadshow 11

Scope of MEDDEV 2.1/6 Scope is stand alone software (no embedded software) Defines criteria for software being a stand alone medical device (qualification criteria) Potential risk arising from the use of stand alone software is not enough to qualify the software as a medical device Explains application of classification rules for stand alone software 12

Software is a medical device if (A) Software is a computer program (B) Software is not incorporated in a medical device (C) Software action is more than basic data processing (D) Software has benefit for individuals (E) Intended purpose is acc. to MDD or software is an accessory acc. to MDD s definition Software falls under MDD regulations 13

MEDDEV 2.1/6: Criterion (A) Software is a computer program IF c b DO i WHILE IF f g a k A computer program is defined as syntactic unit that conforms to the rules of a particular programming language and that is composed of declarations and statements or instructions needed to solve a certain function, task, or problem. ENDIF d h Definition Source: ISO/IEC 2382-1:1993 Information technology Vocabulary -- Part 1: Fundamental terms. ENDIF e 14

MEDDEV 2.1/6: Criterion (A) Software is a computer program Not a medical device: DICOM files ECG recordings Data in electronic patient record 15

MEDDEV 2.1/6: Criterion (B) Software is not part of a medical device Software as integral part of a medical device Not a device on its own Software program used with general purpose hardware 16

MEDDEV 2.1/6: Criterion (C) Software action more than basic data processing more than Storing, archiving, lossless compression 17

Criterion (C) Software performance more than basic data processing more than Data transfer (communication) Location A Location B Presentation of information for embellishment purposes Before After 18

MEDDEV 2.1/6: Criterion (C) Software performance more than basic data more than Performing simple search Examples of simple search : Searching for blood glucose values measured within January 2012 Number of digital X-ray images which were taken within March 2012 Simple Search excludes: Generation of medical relevant information (search results that help with interpretation or perception) 19

MEDDEV 2.1/6: Criterion (D) Benefit for individuals Not a medical device: - Software which processes population data for scientific purposes - Digitized medical literature Patient Benefit Anonymized Test Population 20

MEDDEV 2.1/6: Criterion (E) Purpose of the software is medical Medical intended purpose according to 93/42/EEC MEDDEV 2.1/6: If the manufacturer specifically intends the software to be used for any of the purposes listed in Article 1(2)a of Directive 93/42/EEC, then the software shall be qualified as a medical device. We have learned: Software is not a medical device if: only basic data processing is performed Software is a medical device if: intended use (as defined by manufacturer) is medical 21

MEDDEV 2.1/6: Criterion (E) Purpose of the software is medical Software might be qualified as a medical device (i.e. have a medical purpose) if it does any of the following to medical information: Create medical information Modify medical information Facilitate perception of medical information Facilitate interpretation of medical information 22

Example: Software as accessory according to the MDD Rainer Sturm / www.pixelio.de Monitoring/controling infusion pump 23

What is the Medical Device? Is it a medical device or an accessory to a medical device? Using 3 rd party devices which are already CE marked? Software on the web, PC, tablet, mobile phone? Home Repository Care Provider 24