Safeguarding public health The Regulation of Software as a Medical Device

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1 Safeguarding public health The Regulation of Software as a Medical Device Dr Head of New and Emerging Technologies Medicines and Healthcare Products Regulatory Agency (MHRA)

2 Crown Copyright 2013 About copyright All material created by the Medicines and Healthcare products Regulatory Agency, including materials featured within these MHRA presentation notes and delegate pack, is subject to Crown copyright protection. We control the copyright to our work (which includes all information, database rights, logos and visual images), under a delegation of authority from the Controller of Her Majesty s Stationery Office (HMSO). The MHRA authorises you to make one free copy, by downloading to printer or to electronic, magnetic or optical storage media, of these presentations for the purposes of private research, study and reference. Any other copy or use of Crown copyright materials featured on this site, in any form or medium is subject to the prior approval of the MHRA. Further information, including an application form for requests to reproduce our material can be found at Material from other organisations The permission to reproduce Crown copyright protected material does not extend to any material in this pack which is subject to a separate licence or is the copyright of a third party. Authorisation to reproduce such material must be obtained from the copyright holders concerned.

3 Software as a Medical Device Introduction Qualification and Classification Future Challenges

4 Safeguarding public health an executive agency of the Department of Health

5 MHRA Remit includes: protecting public health through regulation promoting public health by helping people understand the benefits and risks of products used improving public health by supporting innovation and the development of medicines and medical devices

6 Health and Care system (April 2013)

7 Medical Devices Regulation: Main directives Active Implantable Medical Devices - January 1995 (90/385/EEC) Medical Devices Directive - June 1998 (93/42/EEC) IVD Medical Devices Directive - June 2000 (98/79/EC)

8 A Medical Device is: An instrument, apparatus or appliance (including software) Intended by the manufacturer to be used with humans for Diagnosis, prevention, monitoring, treatment or alleviation of a disease, or compensation for an injury or handicap Investigating, replacement or modification of the anatomy or a physiological process Controlling conception But which does not achieve its principle intended action by physiological, immunological or metabolic means, but which may be assisted in its function by such means.

9 Devices: Importance Examples: Syringes, needles, BP monitors, dental equipment, cardiac pacemakers, joint prosthesis, coronary stents, catheters, therapeutic and diagnostic X ray, MRI scanners, IVDs and much more. 90,000 device families on market 12 billion per annum on devices 200 million maintenance annually 1/25 has an implant 1/10 has an implant, including dental

10 Summary of Directives Single market provision, based on mutual recognition and removal of national measures specify essential requirements introduce controls covering the safety, performance, specification, design, manufacture and packaging of devices specify requirements for assessment of clinical investigation protocols

11 Summary of Directives (Cont) specify requirements for the evaluation of any adverse incidents that occur (Vigilance) introduce a system of classifying devices, and applies a level of control which is matched to the degree of risk inherent in the device introduce the concept of Notified Bodies who check and verify that manufacturers and devices meet the relevant requirements introduce system of registration of medical devices

12 EU Regulatory System investigation action compliance ERs safety, performance Notified Body quality systems design dossier clinical data (literature, C/I) accredit audit Competent Authority European market post market surveillance serious adverse events

13 Manufacturer s Responsibilities To confirm that products meet definitions of a Medical Device or Accessory (plus IVD/AIMDD) To classify their devices, and review and comply with relevant Essential Requirements for these devices To select compliance route and implement the systems required To apply to Notified Body for assessment and/or testing (if applicable). To register products with relevant Competent Authority (if applicable) To make a Declaration of Conformity To apply the CE Mark as per Essential Requirements To operate post market surveillance and vigilance systems

14 Device Classification Class Type Conformity Assessment I Low Risk Manufacturer IIa Medium Risk Notified Body at production IIb High Risk Notified Body at design and production III Highest Risk Notified Body at design and production + verification of design dossiers

15 It is placed on the device by the manufacturer It is a declaration that:- The product conforms with the relevant Essential Requirements It is fit for its intended purpose The product meets all the appropriate provisions of the relevant legislation.

16 Software: Software can be incorporated in medical devices or exist as stand alone software. Active Implantable medical devices Software that directly controls an apparatus such as radiotherapy treatment As an accessory to a medical device Software used on mobile devices- apps

17 Software A new ER was introduced by 2007/47/EC : For devices which incorporate software or 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. This ER must be underpinned by appropriate Harmonised Standards for software development

18 Software: The definition of a Medical Device means that not all software products used in e-health are likely to fall under the Medical Devices Directive. Competent Authorities meeting in Uppsala, Sweden (2009) - the qualification and classification of software- Medical Information Systems A Working Group was established by the European Commission under the Swedish Chairmanship to assess this issue.

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20 Software Qualification as a Medical Device: The definition of a Medical Device was amended by the Directive 2007/47/EC to clarify that software placed on the market on its own could be a Medical Device if it satisfied the definition. It follows that software that does not have such a medical purpose, but is placed on the market for a more general purpose will therefore not be a Medical Device even if a user decides to use it for a medical purpose.

21 Software Qualification as a Medical Device: Examples of software that would not meet the definition of a Medical Device includes: Software only intended for archiving/ retrieving patient records/images without intending to change or interpret them. Electronic prescription software that only replaces conventional paper-based prescriptions and sends them out to a pharmacy. Patient administration software that only deals with appointments, admissions, referrals and billing/invoicing.

22 Software Qualification as a Medical Device: Software that qualifies under the definition of a Medical Device if placed on the market for such a purpose would include: Software that carries out further calculations or interpretations of captured patient data for a therapeutic purpose, e.g. radiation treatment planning, medication dosage calculations. Software that carries out further calculations, enhancements or interpretations of captured data for a diagnostic purpose, e.g. tele-health and remote diagnostics, mass screening and risk assessment tools, helpline/telephone services algorithms.

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25 Software Classification as a Medical Device Software is always considered to be an active deviceoperation of software requires electrical energy Active Implantable Medical Device Directive- has no classification system, as they are all equally critical. Software that might drive the device will be considered an accessory and regulated as such. Currently, the IVD Directive has 4 levels of criticality, determined by functionality, e.g. Trisomy 21 risk software is in List B equivalent to a Class IIb Medical Device.

26 Software Classification as a Medical Device For the Medical Devices Directive, software is classified in accordance with Rules 9-12 of Annex IX: Under Rule 9, some active therapeutic devices are placed in Class IIa or IIb depending on their criticality/risk. Under Rule 10, some active diagnostic devices are placed in Class IIa or IIb depending on their criticality/risk. Rule 11 for administration devices is unlikely to apply to software placed on the market on its own. Rule 12 is a default rule for active devices that do not fit into Rules 9-11, and places devices in Class I, the lowest risk class.

27 Software as a Medical Device - Future : The Working Group on software is to reconvene to consider the rapid developments in this field and the potential regulatory challenges. The revised regulations will impact on the qualification and classification of software.

28 Software as a Medical Device Future Challenges : The rapid development of apps and with the use of open source software allows the manufacturer to also change rapidly. Ensure appropriate vigilance and PMS system exist and can be applied to software. Ensure that the manufacturer can continually assess the compatibility of their software when the operating system on a mobile platform is updated.

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30 Safeguarding public health

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32 Safeguarding public health Thank you for listening

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