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Software Medical Device

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Agenda• Who’s who?• Introduction• Main body of presentation/ Illustration• Key takeaways• References• Q&A

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Agenda• Who’s who?• Introduction• Main body of presentation/ Illustration• Key takeaways• References• Q&A

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Who’s who?• Cyrille MICHAUD – MD101• Software Medical device consultant

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Agenda• Who’s who?• Introduction• Main body of presentation/ Illustration• Key takeaways• References• Q&A

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Introduction• What is Software Medical Device?

• Standalone software• Embedded software

• Intended Use: diagnostic or treatment

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Introduction• Software is everywhere

• Regulatory focus

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Agenda• Who’s who?• Introduction• Main body of presentation/ Illustration• Key takeaways• References• Q&A

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Medical device regulations over the world

CMDCAS

JPAL

TGA

Equiv.FDA

SFDA

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Qualification - Classification

• Is my software a medical device?

• What is its class?

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Simple cases• Keywords:• Embedded in…• Accessory of...• Diagnostic• Treatment.

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Simple cases – for standalone software • Keywords:• Diagnostic• Treatment• Assists, controls a MD

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Borderline cases• Internet of Things• General Wellness

• Intended use!!!

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Borderline cases• Smartphones – Tablets

Send data Statistics – Not MD

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Borderline cases• Smartphones – Tablets

Send data HIS – may be a MD

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Borderline cases• Smartphones – Tablets

Send data Diagnosis Remote Control

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Borderline cases – not a medical device

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Borderline cases – SAAS – IT systems• Intended Use!

• Modular approach

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Qualification• Qualification :

• Europe : MEDDEV 2.1/6• Several useful examples

• USA, 3 Guidances on:• Mobile Medical Application,• Low Risk Devices,• Accessories

• Law Enforcement Discretion

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Classification

• Embedded:• Always class of physical device

• Standalone:• Accessory = classify as a medical device on its own• Drives or influence = class of physical device• Other cases = classify as a medical device on its own

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Classification – on its own• 4 applicable rules

• Rule 10• Class IIa

• Rule 12• Class I

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Classification• Classification:

• Europe : MEDDEV 2.4.1 rev9• Several useful examples

• USA: Product code class• Takes the class of the ”nearest” physical product• USA, 3 Guidances on:

• Mobile Medical Application,• Low Risk Devices,• Accessories

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Classification - consequence• Path to CE mark

• Software =many versions

MD class + choice of manufacturer

Annex IIFull Quality

Management SystemISO 13485

Annex IIICE type Examination

Annex VIIConformity Declaration

Class?Classes IIb & III Classes I and IIa

Annex IVVerification

Annex VProduction QM

Annex VIProduct QM

Choice of manufact. Class I

Class IIa

All classes

IIa and IIb

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Let’s go technical – IEC 62304• IEC 62304 : Software Medical Device Lifecycle

• Software safety class:• Classes A, B, C

≠ MD Class

• Based on risk analysis

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IEC 62304 – development lifecycle

• Class A

• Class B

• Class C

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IEC 62304 - requirements

Class A Class B Class C0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Class

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IEC 62304 – effort perceived by team

Class A Class B Class C0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

ClassAdding conceptionand unit tests

Adding detailed conception with justif.

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Impact for start-ups

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Questions to ask first and above all

• Who are my customers?• Who are the end-users?• What are their needs?• What is my market?• What are the innovations I bring to the market?

Definition of intended use and technical characteristics of the product

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Is my product a medical device?• Criteria:• Diagnosis• Treatment• Accessory of…• Drives, controls... Yes No

Zone of uncertainity

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What is its class?• What is the class of my MD?• MEDDEV 2.4/1• Manual on Borderline classification

• “High” Class?• On all markets?• On one market (class III USA)?• Compared to competitors, to substitutes?

Review the intended use and characteristics…

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Regulatory strategy

T0: Class I

T1: Class IIa

T2: Class IIb

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Impact of regulations• When to bother about regulations

Idea

Researchprototype

Conception, developmentIndustrialisation

ResearchProof of concept

First of series Prototype

A bit when proof of concept is

stable

Especially here!

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To sum-up

• Regulations should not stiffle innovation

• Beware of costs

• Review you product definition

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Q&A• Contact details (Name, Email address & Affiliation)