Abstract
This chapter provides an introduction to the basic legal regulations and harmonized standards for the development and release of biomedical software, which is treated by law as a medical product. The authors will primarily focus on the regulations and recommendations within the European Union, and also delineate and discuss the legal situation exemplarily in selected countries such as the United States, Canada and Australia. In summary, this survey will provide a guideline for researchers and practitioners dealing with software development as a medical product according to the Medical Devices Act.
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References
62A/1013/CDV, IEC 82304-1: Health Software – Part 1: general requirements for product safety (working document). 2015.
Active Implantable Medical Devices 90/385/EEC. Off J Eur Union, L189. 1990;33.
ANSI/AAMI/IEC 62304:2006: Medical device software – software life cycle processes. 2006.
Australian Government, Therapeutic Goods Act 1989 – Sect 41BD, No. 21. 1990.
Bundesgesetz betreffend Medizinprodukte (Medizinproduktegesetz – MPG) StF: BGBl. Nr. 657/1996.
CFR-Code of Federal Regulations Title 21 – Food and Drugs. 2006.
Directive 98/79/EC on in vitro diagnostic medical devices. Off J Eur Union, L331. 1998; 41.
Directive 2007/47/EC. Off J Eur Union, L247. 2007;50.
EN 60601-1:2006+A1:2013 Medical electrical equipment – Part 1: general requirements for basic safety and essential performance.
EN 60601-1-4:1996+A1/1999 Medical electrical equipment – Part 1: general requirements for safety – 4. Collateral standard: Programmable electrical medical systems.
EN 62366:2008 Medical devices – application of usability engineering to medical devices.
EN ISO 13485:2012 Medical devices – quality management systems – requirements for regulatory purposes.
EN ISO 14971:2012 Medical devices – application of risk management to medical devices.
Food and Drugs Act, R.S.C., 1985, c. F-27.
IEC 62304:2006 Medical device software – software life cycle processes.
IEC/TR 80002-1:2009 Medical device software – Part 1: guidance on the application of ISO 14971 to medical device software.
IEEE cyber security, Building Code for Medical Device Software Security. 2015.
IMDRF SaMD Working Group, IMDRF/WG/N10FINAL:2013 – Software as a Medical Device (SaMD): Key Definitions, IMDRF (International Medical Device Regulators Forum). 2013.
MEDDEV 2.1/6. Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices. 2012.
Medical Device Directive MDD 93/42/EEC. Off J Eur Union, L169. 1993;36.
Regulation of the European Parliament and of the Council on Medical Devices, COM(2012) 542 final. 2012.
State Food and Drug Administration of China (SFDA), YY/T 0664–2008 Medical device software – software life cycle processes. 2008.
Therapeutic Goods Administration (TGA), Australian regulatory guidelines for medical devices (ARGMD) Version 1.1. 2011.
U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health, Center for Biologics Evaluation and Research: general Principles of Software Validation – Final Guidance for Industry and FDA Staff. 2002.
U.S. Department Of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health, Center for Biologics Evaluation and Research: mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff. 2015.
Verordnung der Bundesministerin für Gesundheit, Familie und Jugend über das Errichten, Betreiben, Anwenden und Instandhalten von Medizinprodukten in Einrichtungen des Gesundheitswesens (Medizinproduktebetreiberverordnung – MPBV) StF: BGBl. II Nr. 70/2007.
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Schröttner, J., Neubauer, R., Baumgartner, C. (2016). Standards and Regulations for (Bio)Medical Software. In: Wang, X., Baumgartner, C., Shields, D., Deng, HW., Beckmann, J. (eds) Application of Clinical Bioinformatics. Translational Bioinformatics, vol 11. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-7543-4_12
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DOI: https://doi.org/10.1007/978-94-017-7543-4_12
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