Regulatoriske forhold for mhealth Apps. Regler & Dokumentation

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1 mhealth seminar Regulatoriske forhold for mhealth Apps Regler & Dokumentation MedTech Innovation & BioMed Community Claus Lindholt, Mermaid Care A/S Indhold Regler: MD Life-cycle og regulatoriske krav MD Definitioner, klassifikation og veje til CE-mærket Harmoniserede standarder CE vs. FDA proces Nye krav til mhealth SW udviklere Dokumentation for Life cycle, Risk Management og Usability EN62304, ISO14971 & EN62366 Dokumentation for mhealth SW Opsummering 1

2 mhealth seminar Beskyttede markeder for medicinsk udstyr FDA regler EU regler Ubeskyttede markeder for mhealth Apps mhealth Apps kan downloades overalt! 2

3 mhealth seminar Regler for mhealth Apps Et og samme regelsæt for medicinsk stand-alone SW uanset platform PC, tablet eller Smartphone Ingen regulatorisk rabat for mhealth Apps Regulatoriske krav til medicinsk SW Dokumentation for sikkerhed og effektivitet i forhold til påtænkt anvendelse (intended use) SpotMole App Description from Google Play: SpotMole provides a simple way to have a quick check of your skin spots and moles. Take a snapshot of a mole or load a mole's photo from the phone's gallery and let SpotMole do the rest! SpotMole may detect signs of melanoma using image processing and pattern recognition techniques. Spotmole does a scan of relevant dermatological features. DISCLAIMER: SpotMole is by no means a substitute for clinical diagnostics performed by trained dermatologists. SpotMole is not a medical device and should not be considered as such. Regardless of the output of the program you are urged to seek medical advice if you have doubts with a particular skin spot - mole. SpotMole's assessment is for educational purpose only. Use SpotMole at your own risk. 3

4 mhealth seminar CARE - Concussion Assessment & Response Description from Google Play: Sport Version app, or CARE, is a new tool that helps medical professionals and athletic trainers assess the likeliness of a concussion and respond quickly and appropriately to this potentially serious medical situation. The CARE allows users to test an athlete s readiness to return to play via a step-by-step testing regimen. This tool is an invaluable way to assess possible concussions and respond appropriately. Return-to-Play Guide: This part of the app helps to protect children and athletes from further injury by guiding them through a daily exercise routine that tests their ability to return to play. Through a five-day, tiered workout routine, parents can ensure that their child is able to handle the added exercise without further injury or discomfort. All concussion information in this section has been provided by Gerard A. Gioia, PhD and Jason Mihalik, PhD, concussion specialists from the Children s National Medical Center and the Matthew A. Gfeller Sport-Related Traumatic Brain Injury Research Center. MDD Life-Cycle for mhealth Apps Intended use Clinical Trials Clinical Reports & Articles Product Requirements Intended Use & Performance Risk Analysis Controlled Processes Verification & Validation Clinical Evaluation CAPA System Change Control Feedback & Complaints Changes Archiving Vigilance From idea to end-of-life Approval which Distribution requirements? ting& Research Development Projectplan Marke-- Sales Service & End-of-Life Regulatory Requirements Plan for Regulatory Requirements incl.: Strategy Time Schedule Resources Economics MDD Classification MDD Essential Req. Risk Management Standards e.g. SW Life-cycle Clinical Rationale Quality Management Web-site info User instruction National Language Post Market Surveillance Vigilance Reporting Recalls 4

5 mhealth seminar mhealth App Regulatorisk strategi Hvad er anvendelsen for mhealth App? + Er mhealth SW er medicinsk udstyr? + Hvilket direktiv? + Hvilken klassificering? + Hvilken vej til CE-mærket? + Hvilke krav til kvalitetsstyring? + Hvilke standarder gælder? + Hvilke medicinske krav? + Hvordan dokumenteres det hele? = LAV EN PLAN! Definition på medicinsk udstyr - App Se direktivet på link til Lovgivning Bek )» Medicinsk udstyr «: Ethvert instrument, apparat, udstyr, materiale, utensilie (éngangsudstyr), anordning, hjælpemiddel eller enhver anden genstand anvendt alene eller i kombination, herunder edb-programmel, der hører med til korrekt brug heraf, 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. 2)» Tilbehør «: Ethvert produkt, der af fabrikanten er bestemt til at blive anvendt sammen med medicinsk udstyr, for at det medicinske udstyr kan anvendes som planlagt af dets fabrikant. I bekendtgørelsen betragtes tilbehør som selvstændigt medicinsk udstyr. 5

6 mhealth seminar Is the SW a medical device? Meddev 2.1/6 - Qualification and Classification of stand alone software 6

7 mhealth seminar Is the SW MDD or IVD? Meddev 2.1/6 Klassificering af medicinsk SW Stand alone SW er et aktivt medicinsk udstyr SW som styrer et medicinsk udstyr tilhører samme klasse som dette Tilbehør klassificeres som et selvstændigt produkt EU MEDDEV 2.4 /1 Guidance document Classification of medical devices 7

8 mhealth seminar Vejen til CE-mærket - MDD Klassificeringen gælder alene niveauet af kvalitetsstyring de tekniske krav er de samme = Harmoniserede standarder Klasse I anmeldes til CA Sundhedsstyrelsen Klasse Is og Im kræver NB assistance Klasse IIa kræver NB assistance og fuld dokument kontrol Klasse IIb (og III) kræver NB s granskning af dokumentationen og der er begrænsning i valget af kvalitetsstyringsomfang MDD Bilag I - Væsentlige Krav for Apps De generelle krav: Højt sikkerhedsniveau Indbygget beskyttelse Egnethed Stabilitet i ydeevne Transportsikkerhed Afvejning af fordele mod ulemper De specifikke krav findes i de harmoniserede standarder. De specifikke krav: Elektrisk sikkerhed Elektromagnetisk kompatibilitet (EMC) Krav til brugbarhed (usability) Risikoanalyse Mærkningskrav Krav til brugsanvisning Alarmfunktioner Materialesikkerhed Bioforligelighed Sterilitetssikkerhed Mekanisk sikkerhed Brand- og eksplosionssikkerhed Nøjagtighed og stabilitet Strålebeskyttelse Klinisk evaluering 8

9 mhealth seminar Direktiver og Harmoniserede Standarder Direktiver Standarder EU Kommissionen EU Direktiv Standardiseringsorganisation Forslag til EN standard Regeringen Folketinget Dansk lov EU Kommissionen EU Tidende Harmonisering af EN standard Sundhedsministeren Sundhedsstyrelsen Bekendtgørelse MDD nr.1263 af IVDD nr.1269 af Dansk Standard National DS/EN standard Fabrikanten Væsentlige krav Kvalitetsstyring Fabrikanten Medicinsk SW iht. EN standarder Bemyndiget Organ Overensstemmelse Klasse IIa/IIb Akkrediteret Laboratorium Testrapporter Bemyndiget Organ Sundhedsstyrelsen Overvågning 0543 Find Dir. & Harm.Std. på CE vs. FDA proces EU for CE-mærkning (MDD) Definition af medicinsk udstyr Direktiv MDD eller IVDD Klassifikation I, Im, IIa eller IIb Annex for vej til CE-mærkning Kvalitetsstyring ISO13485 Technical File (TF) Klinisk rationale (litteratur) Registrering Sundhedsstyrelsen eller NB-audit CE-mærke (markedsføringstilladelse med NB nummer) USA for FDA Clearance Definition af medicinsk udstyr FDA Panel, Part & subpart Klassifikation I, II eller III Exempt, 510(k) eller PMA Kvalitetsstyring QSR (ISO13485) TF = DHF + DMR Klinisk rationale (US forsøg?) FDA submission og FDA audit proces FDA markedsføringstilladelse (Clearance Letter) 9

10 mhealth seminar EN62304 Software for medicinsk udstyr Livscyklusprocesser for medicinsk software Harmoniseret standard for MDD og IVDD Accepteret (recognized) af FDA Livscyklusprocesser for SW? Input Brugerkrav Projektplan Standarder SW Udvikling Output SW dokumentation Eksekverbar kode Verifkationsdokumentation Proceskontrol Proceskrav Livscyklus EN62304 QA-Dokumentation 10

11 mhealth seminar From MDD Life Cycle to EN62304 SW-Development MDD Product Life cycle Research Business Plan & Devel. CE-mark Distribution Marketing & Sales Service & EoL ISO13485 Control Concept Costumer Requirements Development Verification Validation Transfer Product Risk Management Process From MDD Life Cycle to EN62304 SW-Development MDD Product Life cycle Research Business Plan & Devel. CE-mark Production Marketing & Sales Service & EoL ISO13485 Control Concept Costumer Requirements Development Verification Validation Transfer Product Risk Management Process EN62304 SW 5.1 Planning 5.2 Req. Analysis 5.3 Architecture 5.4 Detailed 5.5 Unit Impl. & Test 5.6 Integrat. & Test 5.7 System Test 5.8 Release 7. SW Risk Management Process 8. SW Configuration Management Process 9. SW Problem Resolution Process 11

12 mhealth seminar EN SW Dev. Life Cycle MDD, Bilag I, væsentlige krav 12.1.a. For udstyr, der inkorporerer software, eller i sig selv er medicinsk software, skal softwaren valideres i overensstemmelse med det aktuelle tekniske niveau, idet der tages hensyn til principperne for udviklingslivscyklus, risikostyring, validering og verificering. Annex I, ER 12.1.a. 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. SW Development Processes Documented life-cycle with: Development Plan Milestones Activites Documentation Development life-cycle must include: Requirements specification Architecture specification Sub-system design and test specifications Verification Validation 12

13 mhealth seminar EN62304 Klassifikation af software Risk Management Proces efter EN ISO Class A: No injury possible Class B: non-serious injury Class C: death or serious injury Validering afhænger af klasse De-klassificering ved HW risk control SW risk control samme klasse som kontrollerede hazard Segregering skal dokumenteres SW Risk Management SW som medicinsk udstyr Kilde: AAMI TIR32:2004 Medical device software risk management 13

14 mhealth seminar Medicinsk SW - funktionstyper Særlige risiko egenskaber ved medicinsk SW SW kan ikke i sig selv påføre skade Risikoanalyse ikke gennemføres på SW alene HW platform, kommunikation og tilkoblet udstyr skal med En mobil platform kan kommunikere på mange måder: WiFi, Bluetooth, ANT/ANT+, NFC, 3G, 4G ALT skal granskes for bidrag til risiko, f.eks. manglende dækning eller ingen server forbindelse SW er systematisk af natur og fejler ikke tilfældigt derfor bruges sandsynlighed ikke. Risiko for SW fejl er 100%! Alle årsager må derfor undersøgers og imødegås, hvis de er kritiske. 14

15 mhealth seminar SW Risk Management SOUP Software of Unknown Provenance Også kaldet tredje parts software Styresystemer, udviklingsystemer (biblioteker), run-time fortolker (Java), kommunikations SW, drivere etc. Hvis der skiftes version af udviklingssystem, kan det betyde ny komplet SW-test og SW-validering Hvis SOUP bruges, skal det altid være under versionskontrol og enten valideres, overvåges eller isoleres 15

16 mhealth seminar EN62366 Medicinsk udstyr Indbyggelse af anvendelighed (Usability) Indblanding Smutter Utilsigtet Huskefejl Tilsigtet Dokumentation af medicinsk SW 16

17 mhealth seminar BRDPhase 1 CRS Phase 2 Phase 3 Phase 3 & 4 Phase 4 SRS Risk Management Process Legend: BRD Business Rationale Document CRS Customer Requirement Specification VaTP Validation Test Plan VaTR Validation Test Report SRS System Requirement Specification VeTP Verifictaion Test Plan SDS System Specification ITP Integration Test Plan ITR Integration Test Report xdd Document (x= S for SW, H for HW, U for Usability & M for M echanics) MTP M odule Test Plan MTR Module Test Report RMF = Risk Management File DHF History File DMR Device Master Record Mermaid Care QMS Control Process Phase V-Model and Controlled Documents RMF SDS xdd VaTP VeTP ITP MTP Class C EN62304 Class A,B,C Class B,C MTR ITR VeTR Verification Process VaTR Phase 4 Phase 4 Phase 5 Phase 6 Phase 7 V.1.1 / / CL DHF Legend: Phase 1: Product Proposal Phase 2: Product Requirements Phase 3: Phase 4: Development Phase 5: System Verification Phase 6: System Validation Phase 7: Product Release DMR 10 Technical File for CE-marking of Stand-alone SW MDD Product Life cycle Research Business Plan & Develop. CE-mark Production Marketing & Sales Service & End-of-Life Clinical Articles (optional) Business Rationale (optional) Classification Essential Req. Standards Clinical Rationale Declaration Final Test Final Control Brochures Web-site EN13485 Control Concept Costumer Requirem. Development Verification Validation Transfer Proof of Concept Clinical Articles (optional) CRS RMF VaTP VaTPr VaTR DMR: SW-executable SW Configuration Manuals Labels Packaging Work Instructions EN62304 SW 5.1 Planning 5.2 Requirem. Analysis 5.3 Architecture 5.4 Detailed 5.5 Unit Implem. & Test 5.6 Integration & Test 5.7 System Test 5.8 Release PMP SRS SAS SDD s MTR s ITR VeTPR SW Config SW-RMF SDS + UEF MTPr s VeTPr ITPr MTP s EN62304 doc s: VeTP ITP Class A, B and C Class B and C Class C 17

18 mhealth seminar Required QMS Procedures MDD Product Life cycle Research Business Plan & Develop. CE-mark Production Marketing & Sales Service & End-of-Life CE-marking Process Post Marketing Surveilance Vigilance EN13485 Control Concept Costumer Requirem. Development Verification Validation Transfer Risk Management Sub-contracting of Development EN62304 SW 5.1 Planning 5.2 Requirem. Analysis 5.3 Architecture 5.4 Detailed 5.5 Unit Implem. & Test 5.6 Integration & Test 5.7 System Test 5.8 Release SW Control EN62304 Document Control SW Risk Management Configuration Management Problem Resolution Required Quality Records MDD Product Life cycle Research Business Plan & Develop. CE-mark Production Marketing & Sales Service & End-of-Life Management Reviews Standards DHR: P/O Records Test Records Control Records Complaints Accident Reports EN13485 Control Concept Costumer Requirem. Development Verification Validation Transfer Sub-contracting of Development EN62304 SW 5.1 Planning 5.2 Requirem. Analysis 5.3 Architecture 5.4 Detailed 5.5 Unit Implem. & Test 5.6 Integration & Test 5.7 System Test 5.8 Release Phase Reviews Document Reviews Configuration Records Release Notes Training Records Problem Reports 18

19 mhealth seminar Udvikling og CE-mærkning af mhealth Apps Opsummering Regulatory Strategy for CE-marking of mhealth Apps Costumer Requirements Intended Use definition Product properties mhealth SW Harmonized Standards List of applicable Medical device? Yes Applicable Directive MDD or IVDD (AIMDD) Device Classification: MD: I, Im, Is, IIa, IIb, III IVD: Other, Selftest, List A, B Route to CE-mark CA application or NB No Other rules & standards? e.g. EPJ or LIS Directive Requirements: Essential Requirements Clinical Rationale IVD Performance Eval.. Other directives to consider: RoHS, Reach, WEEE etc. Technical File Content DHF + DMR Scope & content of QMS QM+QOP+WI+QF+QR CE Conformity doc. PMS & Vigilance Project Plan including Regulatory Strategy and Deliverables Develop Product Documentation Establish QMS Directive + EN ISO13485 Develop MDD/IVDD Conformance Documentation 19

20 mhealth seminar Documentation for CE-marking of mhealth Apps Project Plan including Regulatory Strategy and Deliverables Develop Product EN62304 EN62366 ISO14971 (EN ) Develop QMS Directive + EN/ISO13485 Clinical Performance doc. EN14155 EN13612 Verify Product DHF Implement QMS Quality Records Essential Requirements Product Lifetime Validate Product DMR + DHR Internal Audit QMS + all doc s MD Clinical Rationale IVD Performance Val. Decl. of Conformance Notified Body Audit (Annex? + ISO 13485) Review of ALL documents xxxx Product Changes Quality Records Management review Clinical Improvement Post Market Surveillance Vigilance Litteratur og links Sundhedsstyrelsen Meddev 2.1/6 Qualification and Classification of stand alone software Meddev 2.4/1 Classification of Medical Devices FDA - Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff bilemedicalapplications/ucm htm GSMA - Understanding Medical Device Regulation for mhealth - A Guide for Mobile Operators df MobiHealthNews 20

21 mhealth seminar Spørgsmål og diskussion Kontakt: mobil: LinkedIn: dk.linkedin.com/in/clauslindholt/ 21