mapping your success - bsi group...9/24/2013 • scope is stand alone software (no embedded...

Copyright © 2013 BSI. All rights reserved.

Mapping Your Success

2013 BSI Healthcare Roadshow: Mobile Health – Software, Mobile Phones and Telemedicine Under the EU Approach

Copyright © 2013 BSI. All rights reserved. 2

Telemedicine & mHealth

9/24/2013

Definition of Telemedicine: • Use of telecommunication and information technologies in order to provide clinical

health care at a distance. (Source: www.wikipedia.edu)

Definition of mobile health (mHealth): • Practice of medicine and public health, supported by mobile devices.

• The term is most commonly used in reference to using mobile communication devices, such as mobile phones, tablet computers and PDAs, for health services and information… mHealth applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient vital signs, and direct provision of care (via mobile telemedicine).

(Source: www.wikipedia.edu)

• When are mobile and other telemedicine devices and their software

applications considered to be medical devices?


Directives, Standards, & Guidance Documents

9/24/2013

Directives - Mandatory

• 93/42/EEC (MDD)

• 90/385/EEC (AIMDD)

• 98/79/EC (IVDD)

Harmonized Standards*

• EN ISO 14971

• EN ISO 13485

• EN IEC 62304

• EN 60601-1 • EN 62366

Non-harmonized Standards**

• ISO/IEC 12207

• EN IEC 61010-1

Guidance Documents***

• MEDDEV 2.1/6

• IEC/TR 80002-1

• NB-MED/ 2.2/Rec4

* Harmonized standards provide a presumption of conformity with the essential requirements of the directives. ** Use of non-harmonized standards can help provide compliance with directives. *** Guidance documents are agreed upon (by Competent Authorities, Notified Bodies, Industry, etc.) directive interpretations and if followed, ensure uniform application of relevant directive provisions → Legally not binding


European Harmonized Standards

Standard Topic EN 62304 Medical device SW – SW lifecycle processes

EN ISO 13485 Medical devices - Quality management systems – Requirements for regulatory purposes

EN ISO 14971 Medical devices – Application of risk management to medical devices (Note: Normative reference in EN 62304)

EN 60601-1 Medical electrical equipment – General requirements for basic safety and essential performance – Section 14: Programmable electrical medical systems (PEMS) (Note: Not harmonized to IVD Directive)

EN 62366 Application of usability engineering to medical devices


International Guidance

Guidance Topic

MEDDEV 2.1/6 (2012) Guidelines for the qualification and classification of standalone SW used within healthcare within the regulatory framework of medical devices

IEC/TR 80002-1:2009 Medical device SW - Part 1: Guidance on the application of ISO 14971 to medical device SW

NB-MED/2.2/Rec4 SW and Medical Devices (2001)

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

Picture Archiving and Communication Systems (PACS) is included


MDD 93/42/EEC M5 (2007/47) Changes

9/24/2013

1. Article 1: Change of Definition of Medical device - ‘medical device’ means any instrument, apparatus, appliance, software, material or other article…

2. New sub-clause ER 12.1a: “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.”

3. Annex IX – Active Medical Device definition in the classification criteria added – “Stand alone software is considered to be an active medical device.”


Definition of Accessory

9/24/2013

• An article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.


Medical Device Classification

9/24/2013

Directive Classification Accessory

AIMD Directive All AIMDs are one classification (considered high risk)

All AIMD accessories are given same high risk classification

MD Directive Rule-based Accessories are classified in their own right

IVD Directive List, not rule-based (List A - high -or- List B - moderate risk devices)

Accessories are classified in their own right

* If SW is embedded in a medical device, it takes on the classification of the medical device *


Classification of stand alone software (Annex IX 93/42/EEC)

9/24/2013

• Definition: Stand alone software is an active device

Applicable active device rules

Non invasive devices

Rules 1 to 4

Invasive devices

Rules 5 to 8

Additional rules applicable to active devices

Rule 9 Rule 10 Rule 11 Rule 12

Special rules

Rules 13 to 18


Classification of stand alone SW(Annex IX)

9/24/2013

Rule # Summary Classification

9 All active therapeutic devices intended to administer or exchange energy

Class IIa unless potentially hazardous way then Class IIb

10 Active devices intended for diagnosis

Class IIa or Class IIb (e.g. ionizing radiation)

11 Active devices to administer or remove medicines, body liquids, or other substances

Class IIa unless potentially hazardous way then Class IIb

12 All other Active Devices (“fall through” rule)

Class I

• Annex IX, 2.3: SW which drives a device or influences the use of a device, falls automatically in the same device class.


MEDDEV 2.1/6

GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES

2013 Medical Device Roadshow


Scope of MEDDEV 2.1/6

9/24/2013

• Scope is stand alone software (no embedded software) • Defines criteria for software being a stand alone medical device (qualification criteria)

• Potential risk arising from the use of stand alone software is not enough to qualify the software as a medical device

• Explains application of classification rules for stand alone software


Software is a medical device if…

9/24/2013

(A) Software is a computer program

(B) Software is not incorporated in a medical device

(C) Software “action” is more than “basic data processing”

(D) Software has benefit for individuals

Software falls under

MDD regulations

(E) Intended purpose is acc. to MDD or software is an accessory acc. to MDD’s definition


MEDDEV 2.1/6: Criterion (A) – Software is a computer program

9/24/2013

A computer program is defined as syntactic unit that conforms to the rules of a particular programming language and that is composed of declarations and statements or instructions needed to solve a certain function, task, or problem.

Definition Source: ISO/IEC 2382-1:1993 Information technology – Vocabulary -- Part 1: Fundamental terms.

IF

IF

ENDIF

ENDIF

DO

WHILE

a

b

c

f

e

g

d

h

i k


MEDDEV 2.1/6: Criterion (A) – Software is a computer program

9/24/2013

Not a medical device: • DICOM files • ECG recordings • Data in electronic patient record


MEDDEV 2.1/6: Criterion (B) – Software is not part of a medical device

9/24/2013

Software as integral part of a medical device

→ Not a device on its own Software program used with general

purpose hardware


MEDDEV 2.1/6: Criterion (C) – Software “action” more than basic data processing

9/24/2013

“more than”… • Storing, archiving, lossless compression


Criterion (C) – Software “performance” more than basic data processing

9/24/2013

“more than”… • Data transfer (communication)

• Presentation of information for “embellishment purposes”

Location A Location B

Before

After


MEDDEV 2.1/6: Criterion (C) – Software “performance” more than basic data

9/24/2013

“more than” … • Performing “simple search”

Examples of “simple search” : • Searching for blood glucose values measured within January 2012 • Number of digital X-ray images which were taken within March 2012

“Simple Search” excludes:

Generation of medical relevant information (search

results that help with interpretation or perception)


MEDDEV 2.1/6: Criterion (D) – Benefit for individuals

9/24/2013

Not a medical device: - Software which processes population data for scientific purposes - Digitized medical literature

Patient Benefit

Anonymized Test Population


MEDDEV 2.1/6: Criterion (E) – Purpose of the software is medical

9/24/2013

Medical intended purpose according to 93/42/EEC

MEDDEV 2.1/6: “If the manufacturer specifically intends the software to be used for any of the purposes listed in Article 1(2)a of Directive 93/42/EEC, then the software shall be qualified as a medical device.”

We have learned:

Software is not a medical device if:

only “basic data processing” is performed

Software is a medical device if:

intended use (as defined by manufacturer) is medical


MEDDEV 2.1/6: Criterion (E) – Purpose of the software is medical

9/24/2013

Create medical information

Modify medical information

Facilitate perception of

medical information

Facilitate interpretation of medical information

Software might be qualified as a medical device (i.e. have a medical purpose) if it does any of the following to medical information:


Example: Software as accessory according to the MDD

9/24/2013

©

Rain

er S

turm

/ w

ww

.pix

elio

.de

Monitoring/controling infusion pump


What is the Medical Device?

• Is it a medical device or an accessory to a medical device?

• Using 3rd party devices which are already CE marked?

• Software on the web, PC, tablet, mobile phone?

Home

Repository

Care Provider