Hvornår skal digitale løsninger CE-mærkes som medicinsk udstyr? v/ Kristoffer Madsen, specialist i Delta part of FORCE Technology

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1 Hvornår skal digitale løsninger CE-mærkes som medicinsk udstyr? v/ Kristoffer Madsen, specialist i Delta part of FORCE Technology

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3 COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices 93/42/EEC, Article 1, Section 2 (a) For the purposes of this Directive, the following definitions shall apply: (a) medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

4 Elastik A ( Elastik B ( Navn Træningselastik Rehabiliteringselastik Formål (Intended Purpose) Træningselastikken er beregnet til hjemmetrænings og holdtræning eller genoptræning Rehabiliterings elastikken er specielt egnet til at lindre og forebygge skulderlidelser ICD-10 M75 Anprisninger (Caims) Få faste baller hurtigt med denne elastik Blev smertefri 3 uger hurtigere med denne elastik Medical Claim

5 MEDDEV 2.4/1 It is the intended and not the accidental use of the device that determines the class of the device MEDDEV 2.4/1

6 Domstolens dom i sag C-219/11

7 COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices 93/42/EEC, Article 1, Section 2 (a) For the purposes of this Directive, the following definitions shall apply: (a) medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

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12 MEDDEV 2.1/6 if the software does not perform an action on data, or performs an action limited to storage, archival, communication, "simple search" or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device. Altering the representation of data for embellishment purposes does not make the software a medical device. In other cases, including where the software alters the representation of data for a medical purpose, it could be a medical device Stand alone software for general purposes when used in a healthcare setting is not a medical device."

13 Beslutningsunderstøttende systemer Hvad er mobilapplikationens formål? Er formålet med applikationen at (direkte eller indirekte) diagnosticere, forebygge, behandle, overvåge eller lindre en sygdom? Hvem er det i virkeligheden, der tager beslutningerne? Behandler applikationen data på en måde, der adskiller sig fra lagring, arkivering, kommunikation, simpel søgning eller databevarende kompression?

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16 Klassificering

17 BEK Aktivt medicinsk udstyr Ethvert medicinsk udstyr, som for at kunne fungere er afhængig af en elektrisk energikilde eller af enhver anden form for energi end den, der udvikles direkte af det menneskelige legeme eller af tyngdekraften, og som virker ved at omsætte denne energi. Et medicinsk udstyr, der er beregnet til uden nogen væsentlig ændring at overføre energi, stoffer eller andre elementer mellem et aktivt medicinsk udstyr og patienten, anses ikke for at være et aktivt medicinsk udstyr. Stand alone-software anses for at være aktivt medicinske udstyr.

18 Active Devices

19 Regel 10 Aktivt udstyr, der er beregnet til diagnosticering, henhører under klasse IIa hvis det er beregnet til at afgive energi, som absorberes af det menneskelige legeme, bortset fra sådant udstyr, som anvendes til at belyse patientens legeme ved hjælp af synligt lys hvis det er beregnet til at afbilde in vivofordelingen af radiofarmaka hvis det er beregnet til at muliggøre en direkte diagnosticering eller overvågning af vitale fysiologiske processer, medmindre det er specielt beregnet til at overvåge vitale fysiologiske parametre, hvor variationer for visse af parametrenes vedkommende, navnlig variationer i hjertefunktionen, vejrtrækningen eller centralnervesystemets aktivitet, kan udgøre en umiddelbar fare for patienten, idet det i så fald henhører under klasse IIb. Aktivt udstyr, der er beregnet til at udsende ioniserende stråling og beregnet til røntgendiagnostik og radioterapi, herunder udstyr, der styrer eller overvåger sådant udstyr, eller som direkte påvirker dets ydeevne, henhører under klasse IIb.

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21 Special Rules

22 Use Guidelines! MEDDEV 2.4/1 Classification of Medical Devices MEDDEV 2.1/6 Qualification and classification of stand alone software Borderline Manual - Version 1.17 ( ) MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

23 CE mærket i 8 små skridt Quality Management Risk Analysis

24 Use Standards! Quality Mangement ISO 13485:2016 Medical devices - Quality management systems Requirements for regulatory purposes Risk Management DS/EN ISO 14971:2012 Medical devices - Application of risk management to medical devices Usability IEC 62366:2015 Medical devices Part 1: Application of usability engineering to medical devices Software IEC 62304:2015 Medical device software - Software life-cycle processes Clinical Evaluation MEDDEV 2.7/1 revision 4 Clinical evaluation. Guide for manufacturers and notified bodies under directive 93/42/EEC and 90/385/EEC Labelling and Packaging EN ISO :2012 Symbols to be used with medical device labels, labelling and information to be supplied EN 1041:2008 Information supplied by the manufacturer of medical devices.

25 Apply CE mark

26 LinkedIn: