Agenda. Introduction. 1. Impact of the MDR on mhealth apps qualification. 2. Impact of the MDR on mhealth apps classification
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1 Ageda Itroductio 1. Impact of the MDR o mhealth apps qualificatio 2. Impact of the MDR o mhealth apps classificatio 3. Essetial requiremets & cliical evidece 4. Uique Device Idetificatio (UDI) Q & A Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 1
2 Itroductio
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3 Itroductio Why is the medical devices legislatio relevat for the mobile health idustry? Medical device (curret defiitio): q Ay istrumet, apparatus, appliace, software, material or other article, whether used aloe or i combiatio, [ ] Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 3
4 Itroductio Why is the medical devices legislatio relevat for the mobile health idustry? Medical device (curret defiitio): q Havig oe of the followig iteded purposes : Diagosis, prevetio, moitorig, treatmet or alleviatio of disease, Diagosis, moitorig, treatmet, alleviatio of or compesatio for a ijury or hadicap, Ivestigatio, replacemet or modificatio of the aatomy or of a physiological process, Cotrol of coceptio, q... Ad which does ot achieve its pricipal iteded actio i or o the huma body by pharmacological, immuological or metabolic meas, but which may be assisted i its fuctio by such meas. Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 4
5 Itroductio Why is the medical devices legislatio relevat for the mobile health idustry? Today: EU medical devices DIRECTIVE 93/42 (o direct effect) q (Stad-aloe) software : Limited regulatio withi the EU directive 93/42 q Mobile health applicatios : May fall withi (stad-aloe) software ; absece of specific legally-bidig rules (guidelies oly) To be replaced by a EU medical devices REGULATION (direct effect) Aim of this presetatio: focusig o ew rules i the MDR which are specific to the mobile health idustry Not all rules, ot all ew rules (i.e. the examples preseted today are ot the oly chages brought by the MDR for the idustry) Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 5
6 Itroductio The MDR: state of play Iitial MDR draft proposals dated 26 September 2012 Last cosolidated versio of MDR proposal dated 09 August 2016 (available olie) The jurist-liguist traslatio eded o 17 October 2016 Practically speakig, the mai aspects of the text are fixed Issues likely to be arraged through implemetatio Several delegated acts of the Europea Commissio are expected to address these issues Fial publicatio : expected by Q or later Etry ito force of the MDR (trasitio period): 3 years Q or later Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 6
7 1. Impact of the MDR o mhealth apps qualificatio
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8 1. Impact of the MDR o mhealth apps qualificatio Recital (18a) of the MDR : clarificatio It is ecessary to clarify that software i its ow right, whe specifically iteded by the maufacturer to be used for oe or more of the medical purposes set out i the defiitio of a medical device, is qualified as a medical device, [ ] ü ü ü Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 8
9 1. Impact of the MDR o mhealth apps qualificatio Recital (18a) of the MDR : clarificatio While software for geeral purposes, eve whe used i a healthcare settig, or software iteded for life-style ad well-beig applicatio is ot a medical device. û û û Workout Apps measurig heartrate apps Sleep moitorig apps Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 9
10 1. Impact of the MDR o mhealth apps qualificatio Borderlie cases? Examples: electroic medical record apps ; apps for the commuicatio betwee patiet ad caregivers while givig birth ; video appoitmet software Today: guidace ca be foud i the MEDDEV guidace o stad-aloe software (July 2016) ad EU maual o borderlie classificatio (September 2015) Uder the MDR: adaptatio of existig guidelies + further guidace to be adopted Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 10
11 2. Impact of the MDR o mhealth apps classificatio
12 2. Impact of the MDR o mhealth apps classificatio Classificatio of mobile health applicatios Classificatio Qualificatio Lower level of risk Higher level of risk Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 12
13 2. Impact of the MDR o classificatio Classificatio of mobile health applicatios New rule 10a (MDR proposal), dealig specifically with software classificatio: 1. Class IIa for software iteded to provide iformatio used to take decisios with diagosis or therapeutic purposes Uless the decisios have a impact that may directly or idirectly cause death or irreversible deterioratio of state of health ( Class III), or serious deterioratio of the state of health or surgical itervetio ( Class IIb) 2. Class IIa for software iteded to moitor physiological processes Uless it is iteded for moitorig of vital physiological parameters, where the ature of variatios is such that it could result i immediate dager to the patiet ( Class IIb) 3. All other software: Class I Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 13
14 3. Essetial requiremets & cliical evidece
15 3. Impact o essetial requiremets ad cliical evidece Essetial requiremets Essetial requiremets = geeral safety ad performace requiremets imposed by the law Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 15
16 3. Impact o essetial requiremets ad cliical evidece Essetial requiremets New rules relevat for mhealth apps maufacturers / desigers (examples): q q Devices shall be desiged ad maufactured i such a way as to remove or reduce as far as possible the risks associated with the possible egative iteractio betwee software ad the IT eviromet withi which it operates ad iteracts MDR, Aex I, article 11.2, (e) Software iteded to be used i combiatio with mobile computig platforms shall be desiged ad maufactured takig ito accout the specific features of the mobile platform (e.g. size ad cotrast ratio of the scree) ad the exteral factors related to their use (varyig eviromet as regards to level of light or oise) MDR, Aex I, article q I the evet of a sigle fault coditio, appropriate meas shall be adopted to elimiate or reduce as far as possible cosequet risks or impairmet of performace MDR, Aex I, article Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 16
17 3. Impact o essetial requiremets ad cliical evidece Cliical evidece Cliical evidece = evidece ecessary to demostrate compliace with the relevat essetial requiremets o safety ad performace Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 17
18 3. Impact o essetial requiremets ad cliical evidece Cliical evidece New rules relevat for mhealth apps maufacturers (examples): q The techical documetatio should iclude detailed iformatio o software verificatio ad validatio : Describig the software desig ad developmet process ad evidece of the validatio of the software, as used i the fiished device Icludig summary results of all verificatio, validatio ad testig performed both i-house ad i a simulated or actual user eviromet prior to fial release Addressig all of the differet hardware cofiguratios ad, where applicable, operatig systems idetified i the iformatio supplied by the maufacturer MDR, Aex II, article 6.1. Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 18
19 4. Uique Device Idetificatio (UDI)
20 4. Uique Device Idetificatio (UDI) Uder the MDR: the UDI becomes compulsory for all medical devices Icreased traceability The UDI is a series of umeric or alphaumeric characters that is created through a globally accepted device idetificatio ad codig stadard It allows the uambiguous idetificatio of a specific device o the market The UDI is comprised of the DI (device idetifier) ad the PI (productio idetifier) I additio to the existig labellig requiremets for medical devices Easier recall Improved patiet safety Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 20
21 4. Uique Device Idetificatio (UDI) Uder the MDR: the UDI becomes compulsory for all devices Examples: Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 21
22 4. Uique Device Idetificatio (UDI) New specific rules for software Placemet criteria: o a readily accessible scree for the user i a easily readable plai-text format (e.g. a about file or icluded o the start-up scree) MDR, Aex V, C, Obligatio to affix a ew UDI-ID (e.g. i case of a ew or modified operatig platform, or ew user iterface, modificatio of the iteded use of the software) MDR, Aex V, C, 6.5.1a. Obligatio to affix or a ew UDI-PI (e.g. upo mior software revisio such as bug fixes or usability ehacemets which are ot for safety purposes ) MDR, Aex V, C, 6.5.1b. Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 22
23 Coclusios New specific rules for software Prepare yourself Oce the text is published 3 years trasitio period for MDR All areas are ot covered by the MDR (examples) Data protectio EU data protectio regulatio ad EU (draft) Code of Coduct o privacy for mobile health applicatios Cyber security EU (draft) Code of Coduct o privacy for mobile health applicatios Apps quality ad assessmet EU (draft) guidelies o assessmet of the reliability of mobile health applicatios Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parterships ad other etities
24 Thak you Questios?
25 Simmos & Simmos LLP Simmos & Simmos is a iteratioal legal practice carried o by Simmos & Simmos LLP ad its affiliated parters hips ad other etities. 25
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