regulations and standards for the lifecycle of medical and ivd … · 2016-02-15 · • 2007...

Regulations and standards for the

Medical & IVD Devices Regulations and Standards

Regulations and standards for the

lifecycle of medical and IVD devices

(hardware and software)

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Claudio Barella

Istituto di BioRobotica Scuola Superiore Sant’Anna Pontedera, 2016-02-10

Summary

• # Part 1: The international regulatory framework

• # Part 2: specific regulations for each market area


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• # Part 3: Medical devices and IVD (hardware and software)

• # Part 4: The technological evolution of the devices

# Part 1

The international regulatory framework

for regulations and standards for the



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(hardware and software) has evolved

over the past twenty years and is still

evolving.

Evolution of Regulatory Framework

(Standards and Regulations)


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1970 1980 1990 2000 2010 2020

…..”Medical errors as the cause of

nearly 100,000 deaths per year

in the US healthcare system”


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in the US healthcare system”

by the US Institute of Medicine in 1994

in its book:

“To err is human: Building a safer health system”

• Evolution of Medical Devices Regulatory Systems and Standards (1970-1990):

• 1970 (USA) FDA (Food and Drug Administration) recommended to start the

medical devices regulatory system .

• 1977 first edition of IEC 60601 Techhnical Standards family for safety and

effectiveness of medical electrical equipment.


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• 1978 (USA) GMP (Good Manufacturing Practice) requirements for medical devices.

• 1979 (UK) BSI (British Standard Institution) BS 5750 Quality systems”.

• 1987 ISO 9001 1st Edition “Quality systems”.

• 1990 Design control in GMP.

•

• 1990 Europe 90/385/EEC Active Implantable Medical Devices European Directive.


• 1993 93/42/EEC Medical Devices European Directive.

• 1993 EN 46001 “Quality Systems - Medical Devices - Particular Requirements”

• 1994 European “MEDDEVs” Medical Devices Guidelines (guidance documents to

assist stakeholders in implementing Directives, related to Medical Devices).

• 1994 ISO 9001 2nd Edition “Quality systems”.

• 1996 ISO 13485 1st Edition “Quality systems - Medical devices - Particular


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• 1996 ISO 13485 1st Edition “Quality systems - Medical devices - Particular

requirements for the application of ISO 9001.

• 1996 EN 980 - Graphical symbols for use in the labelling of MDs. (Europe: more

than 25 official languages).

• 1996 USA (21 CFR part 820) Quality System Regulation

• 1997 USA 21 CFR Part 11 Electronic Records (also Software requirements)

• 1997 Europe EN 1441 Medical Devices - Risk Analysis (European Standard)

• 1998 Europe Start CE Mark on Medical Devices 93/42/EEC

• 1998 98/79/EC In Vitro Diagnostic Devices European Directive

• 2000 ISO 9001 Edition 3“Quality Management Systems”


• 2003 ISO 13485 Edition 2

• 2006 IEC 62304 Medical device software – Software life cycle processes

• 2007 ISO 14971 Risk Management

• 2007 IEC/EN 62366 Usability Engineering

• 2007 EU 2007/47 Directive amending 90/385/EEC - 93/42/EEC

2008 ISO 9001 Edition 4


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• 2008 ISO 9001 Edition 4

• 2011 IEC 60601 family: 10 collateral standards and 60 particular standards.

• 2012 EU Draft Regulation for Medical Devices and IVD

• 2013 FDA “Mobile Medical Applications: Guideline” (Medical Apps)

• 2015 ISO 9001 Edition 5

• 2016 ISO 13485 Edition 3

• 201x EU new Regulation for Medical Devices and IVD

# Part 2

Each market area has defined

specific regulations taking into account

the international unified standard

ISO and IEC, however, they require


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ISO and IEC, however, they require

adjustments to the local regulations.

Regional Regulatory Systems

for Medical & IVD Devices Registration

Regolatory Systems:

the Competent Autorithy (CA) requires

registration of Medical and IVD Devices

before to access to the National Market

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before to access to the National Market


for Medical & IVD Devices Registration:

FDA, CMDR, CE, Ghost-R, CFDA, JPAL, KFDA, Anvisa, TGA, etc…

Main Regional Regolatory Systems:

FDA USA, CMDR Canada,

CE European Union, GOST-R Russia,

CFDA China, JPAL Japan, KFDA Korea,

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CFDA China, JPAL Japan, KFDA Korea,

ANVISA Brasil, TAG Australia.

,



Other Local Regolatory Systems:

Argentina, Colombia,

Costa Rica, Egypt,

Hong Kong, India,

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Hong Kong, India,

Israel, Malaysia,

Mexico, New Zealand,

Peru, Saudi Arabia,Singapore,

South Africa, Taiwan, Turkey, ……..



1993 - Global harmonization task force (GHTF)was founded in 1993 by the governments andindustry representatives of Australia, Canada, Japan, the European Union, and the United States of America.

GHTF IMDRF

2011 – International Medical Device Regulators Forum (IMDRF)

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2011 – International Medical Device Regulators Forum (IMDRF)

www.imdrf.org

Was conceived in February 2011 as a forum To discuss future directions in medical device regulatory harmonization.It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), And to accelerate international medical device regulatory harmonization and convergence.



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IMDRF Guidelines

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# Part 3

Medical devices and IVD hardware and

software must implement these

regulatory issues that affect the entire


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regulatory issues that affect the entire

lifecycle in order to be placed in the

local markets.


• European Guidelines “MEDDEV”

• http://ec.europa.eu/growth/sectors/medical-

devices/guidance/index_en.htm

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MEDDEVs Guidelines

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Definition of Medical Devices (Art.1 - 93/42/EEC and 2007/47/EC)

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:

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— 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;

(b) ‘accessory’ means 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;

IEC 62304

Medical device software –

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Medical device software –

Software life cycle

processes

Medical Software Life Cycle IEC 62304

IEC 62304 - Definition

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IEC 62304 – Classification A-B-C

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IEC 62304:

Different

Requirements

for different

Class

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Class


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# Part 4

The technological evolution of devices has

led especially the software to play an

increasing role in medical devices with


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increasing role in medical devices with

increased functional responsibilities

subject to special regulatory

requirements.


The new Challenge for Medical Professionals

and Patient/Users:

Medical Apps (Mobile Medical Applications)

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Medical Apps (Mobile Medical Applications)

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Thanks All for following:

“Regulations and standards for the lifecycle of medical and IVD


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lifecycle of medical and IVD devices (hardware and software)”

regulations and standards for the lifecycle of medical and ivd … · 2016-02-15 · • 2007...

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