Appsog det regulatoriske landskab. DnA Netværket - Medico Innovation 28/ Brian Hedegaard - DELTA

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1 Appsog det regulatoriske landskab DnA Netværket - Medico Innovation 28/ Brian Hedegaard - DELTA

2 I do not object to people looking at their watches when I'm speaking. But I strongly object when they start shaking them to make sure they are still going. William Norman Birkett

3 Agenda DELTA hvem er vi og hvad laver vi Medicinsk udstyr hvad er det Udviklingsprocessen - overblik Case Stand alone software - EU Stand alone software - FDA Case EU-US Revisionen Når du går hjem..

4 DELTA Hvem er vi og hvad laver vi

5 DELTA-facts 300 employees out of which 50% are engineers Annual turnover 42 Mill Euro and 50% export 2,000 customer assignments annually Headquarters in Hørsholm Departments in Odense, Västerås, Wales, Aarhus, Nordborg and Sønderborg 5

6 DELTA- More than test 6

7 DELTA- Technology pathfinder through 70 years 7

8 DELTA Core competences Electronics Microlectronics Software technology Light & Optics Acoustics & vibration Sensor systems Point of care systems Approval processes EMC test Reliability test Wireless test Acoustic test Maturity audits Software validation 8

9 DELTA OEM Capabilities 9

10 Medicinsk udstyr hvad er det

11 Medicinsk udstyr Hvad er det? "Medicinsk udstyr": Ethvert instrument, apparat, udstyr, software, materiale eller anden genstand anvendt alene eller i kombination, herunder software, som af fabrikanten er beregnet til specifik anvendelse til diagnostiske eller terapeutiske formål, og som hører med til korrekt brug heraf, og som af fabrikanten er beregnet til anvendelse på mennesker med henblik på: a) Diagnosticering, forebyggelse, overvågning, behandling eller lindring af sygdomme, b) diagnosticering, overvågning, behandling, lindring af eller kompensation for skader eller handicap, c) undersøgelse, udskiftning eller ændring af anatomien eller en fysiologisk proces, eller d) svangerskabsforebyggelse, og hvis forventede hovedvirkning i eller på det menneskelige legeme ikke fremkaldes ad farmakologisk, immunologisk eller metabolisk vej, men hvis virkning kan understøttes ad denne vej. 11

12 Medicinsk udstyr Hvad er det? Andre kriterier: Produktets tiltænkte anvendelse Grundlag for klassificering Hvad produktet påstås at kunne Manualer Markedsføringsmateriale.. Produktets primære anvendelse 12

13 Udviklingsprocessen - overblik

14 Udviklingsprocessen Approval management Idea Definition Concept Specification Analysis GAP Processes Human factors Configuration management Risk control Eng. Chg. Mgmt. Product test Evaluation Verfication Validation Product approval Registration Vigilance PMS Idea & req. Design Implementation Test Manufacturing & ops. Fase 0-2 Ide Concept studier Mock-ups Usability studier Fase 3 Formel projektstart Kondensering af req Design afklaringer Processer etableret Fase 3 Implementering Reviews Redesign modultest Fase 3 Verifikation Produkttest Klinisk evaluering Design Dossier Fase 4 Produktions klarg. Registrering Markedsføring Markedsovervågning 14

15 Udviklingsprocessen - overblik? Quality Management Risk Analysis Ringer til en ven (med et godt netværk) 15

16 Udviklingsprocessen - overblikket 16

17 Case

18 Case Træning i eget hjem Der er udviklet en platform, hvor borgere har mulighed for at mødes i et virtuelt miljø. Platformen er bl.a. tænkt til brug i forbindelse med genoptræning i borgerens eget hjem. En Fysioterapeut har via en videoforbindelse mulighed for at se borgerne træne, og har mulighed for at kommentere på træningen. Medicinsk udstyr? Platformen udvides med funktionalitet, som muliggør tilkobling af udstyr til måling af blodtryk og oxidation, som videresendes til sundhedssystemet. Medicinsk udstyr? Ingen beregninger eller modifikation af data. Platformen tilføjes nu funktionalitet, så det er muligt for borgeren at se måleresultaterne. Måleresultaterne vises nu på en skala, hvor der markeres med grøn, gul eller rød, afhængig af borgerens blodtryk. 18

19 Stand alone software - EU

20 Standalone software - EU Stand alone software must have a medical purpose to be qualified as medical device. Examples of computer programs are software applications, macros, scripts, dynamically linked libraries, batch files, style sheets and any document containing active formatting or filtering instructions. Examples of digital documents are image files, DICOM files, digital ECG recordings, numerical results from tests and electronic health records (EHR).

21 Stand alone software MEDDEV 2.1.6

22 Standalone software - EU Classification Examples Class I Low risk Class I m/s Measuring / Sterile Class IIa Medium Class IIb Medium High risk products Class III High risk products - Software for the presentation of the heart rate or other physiological parameters during routine checkups (Class IIa); - Software for the presentation of the heart rate or other physiological parameters for intensive care monitoring (Class IIb).

23 Stand alone software - FDA

24 FDA Regulations Scope of the regulation: Traditional medical devices used by healthcare proffessionals Consumer medical devices used in the home or on the go, like a weight scale used in treating obesity mhealth software and hardware (eg. telemedicine) Standalone software used in clinical decision support (CDS)

25 Changes in the regulatory landscape 510(k) programme update General changes: Increased focus on software. Removed flowchart, definitions section, and information from biomaterials compendium. Inclusion of more examples.(..de Novo) Includes changes to safety and effectiveness Attempts to clarify intended use and indications for use interface. Combined IVD Guidance and Medical Device Guidance.

26 More changes 510(k) programme update - Continued Expected to expand the types of changes that require a 510(k) submission Labeling Substantial changes Emphasis on human factors Technology, engineering & performance Human interface emphasized Data transmission considered Changes with how product is used in the field can cause manufacturer to file a new 510(k) Clinical data expanded to consider any data derived from human subjects (impact on journal review, archived samples, human factors)

27 Mobile Medical Application MMA - US Describes what types of mobile apps that will be regulated Describes how manufacturers of apps and mobile technologies (e.g., platforms and online marketplaces) will be regulated Includes algorithms that output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice. Excludes: medical training materials, health & wellness, generic aids, and EHRs

28 MMA - US Medicadevice intended use Device Accessory + = Transforms a mobile platform Mobile Medical App

29 MMA - US Who does what? Anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components. App manufacturer Excludes entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions. Distributor Anyone who commercially markets a mobile platform with an intended use of, or to be used with, a device. Platform manufacturer Excludes entities that solely distribute or market its platform with no device intended use. Component manufacturer

30 MMA Examples Who does what? Anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components. App manufacturer Excludes entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions. Distributor Anyone who commercially markets a mobile platform with an intended use of, or to be used with, a device. Platform manufacturer Excludes entities that solely distribute or market its platform with no device intended use. Component manufacturer

31 Special Controls Usually in the context of clearing a device, FDA will check to ensure that the manufacturer is complying with any published special controls The special controls are typically stated in guidance documents and include, for example: Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations Radio-Frequency Wireless Technology in Medical Devices Guidance for Industry, FDA Reviewers and Compliance on Off- The shelf software Use in Medical Devices General Principles of Software Validation; Final Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Device specific guidance(e.g. Glucose monitors) Guidance on medical device patient labeling Labeling regulatory requirements for medical devices

32 Case There is an app for that

33 Case 2 Redskab til at hjælpe diabetikere med bedre at kunne styre deres blodsukker There is an app for that 33

34 Case 2 App til at hjælpe diabetikere med bedre at kunne styre deres blodsukker Opsamling af information om: - Vægt - Motion - Kalorie indtag - Søvn mængde - Målt blodsukker niveau App en udvides med funktion til beregning af BMI Nej Simple beregninger som BMI og APGAR gør det ikke til medicinsk udstyr App en udvides med funktion til beregning af teoretisk blodsukker niveau Umiddelbart Nej App en har stadig felt til indtastning af målte værdier MEN.. Der er en risiko for at brugeren kan begynde at tolke/agere på baggrund af beregningerne. 34

35 EU vs. US

36 EU US Similarities Software is divided into three categories: 1. Software embedded in a medical device 2. Standalone software 3. Accessories Embedded software is not regulated as a separate medical device Accessory software is regulated at the same level as the device to which it connects General-purpose software used in a healthcare setting is not regulated, unless its specific intended use is that of a medical device

37 EU US Differences Software that merely performs storage, archiving, communication, simple search or lossless compression of medical data is not regulated in the EU In the US, this software would be regulated as a Class I MDDS device, if any of the data is obtained electronically from a medical device In the EU, the default classification for standalone software that is not otherwise classified under the MDD is Class I the lowest-risk classification. In the United States, the default classification is Class III In the US, software that reads and processes information from an IVD generally is regulated as an accessory to an IVD device. In the EU, the regulation of this software depends on the data sources.

38 What else to consider Data protection US: HIPAA(Health Information Privacy and Accountability Act) EU: GDP(jan 2012) Modularization FDA: if interconnected it makes a system EU: Possible to certify only modules Open source? The device! EMC / WL in hospital settings

39 Revisionen

40 Revisionen Tre overordnede mål: Sikre sundhed og sikkerhed for mennesker Sikring af det indre marked Sikre et konsistent regulatorisk rammeværk som fortsat støtter innovation og konkurrenceevne Harmonisering af lovgivningen: Forordning i stedet for direktiv (32 lande, ~80 Notified Bodies)

41 Revisionen Key topics Sporbarhed og transparens : UDI(Unique Device Identifier) og EUDAMED Distance salg (Udstyr og services solgt over internettet) Standalone software (Active device) Præcisering af tilbehør: Udstyr som skal anvendes sammen med et eller flere bestemte medicinsk udstyr for specifikt at muligøre eller assistere det medicinske udstyr til dets tiltænkte anvendelse 14.1 Devices that incorporate electronic programmable systems, including software, or standalone software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance according to the intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible and appropriate consequent risks.

42 Revisionen Key topics 14.2 For devices that incorporate software or for standalone software that are devices in themselves, the software shall be developed and manufactured according to the state of the art taking into account the principles of development life cycle, risk management, verification and validation Software referred to in this Section that are intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards to level of light or noise). 18 Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons 18.1, 18.2, 18.3 Fokus på usability og hensyn til brugerens tekniske formåen. 19 Label and instructions for use

43 Revisionen Statistik MDD 93/42/EC Revisionen Definitioner Artikler Bilag(Annex) Essentielle krav 13(55) 19(65) Brug af delegated acts 0 18 Software nævnt 7 22 Krav til NB Annex XI 7 (1 side) Annex VI 20 (4 sider)

44 Revisionen Key topics Notified Body requirments (Annex VI) (3.2.5) - Software validation skills required Klassifikation (Annex VI) Section II: 2. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used. 3. Stand alone software, which drives a device or influences the use of a device, falls automatically in the same class as the device. If stand alone software is independent of any other device, it is classified in its own right.

45 Når du går hjem..

46 Først en lille quiz Would you consider the software to be a medical device? EU! Software used to plan cancer treatment doses and to control the setting of oncology treatment devices Software used within the overall design and manufacturing processes of the medical devices Software used to measure and calculate the anatomical sites of the body to facilitate the irradiation of surgical intervention Software embedded in an implanted pulse generator device Software used to transmit administrative data such as a patient's name and address YES NO YES YES NO men tænk datasikkerhed!

47 Når du går hjem Husk: Det handler om patient sikkerhed! Det handler om at gøre tingene rigtigt fra starten Det handler ikke kun om hvad du siger. men også om hvad du gør Det handler om at lave kvalitet Kend lov værket, eller kend en der gør og lav et team Kend de centrale standarder og brug dem Vær skarp i definitionen af app ens anvendelse og lad være med at påstå andet. Sørg for at app en er bedre end det der er på markedet hvis du vil have penge for den Skriv det ned = Dokumenter if it is not on paper it does not exist IEC62304, ISO14971,ISO13485, IEC60601

48 48

49 Brian Hedegaard