Regulations and standards for the lifecycle of medical and IVD … · 2016-02-15 · • 2007...
Transcript of 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
Medical & IVD Devices Regulations and Standards
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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
lifecycle of medical and IVD devices
Medical & IVD Devices Regulations and Standards
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lifecycle of medical and IVD devices
(hardware and software) has evolved
over the past twenty years and is still
evolving.
Evolution of Regulatory Framework
(Standards and Regulations)
Medical & IVD Devices Regulations and Standards
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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”
Medical & IVD Devices Regulations and Standards
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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.
Medical & IVD Devices Regulations and Standards
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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.
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• 1990 Europe 90/385/EEC Active Implantable Medical Devices European Directive.
• Evolution of Medical Devices Regulatory Systems and Standards (1990-2000):
• 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
Medical & IVD Devices Regulations and Standards
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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”
• Evolution of Medical Devices Regulatory Systems and Standards (2000-2016):
• 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
Medical & IVD Devices Regulations and Standards
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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
Regional Regulatory Systems
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.
,
Regional Regulatory Systems
for Medical & IVD Devices Registration
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, ……..
Regional Regulatory Systems
for Medical & IVD Devices Registration
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.
Regional Regulatory Systems
for Medical & IVD Devices Registration
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Regional Regulatory Systems
for Medical & IVD Devices Registration
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.
Medical & IVD Devices Regulations and Standards
• European Guidelines “MEDDEV”
• http://ec.europa.eu/growth/sectors/medical-
devices/guidance/index_en.htm
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Medical & IVD Devices Regulations and Standards
MEDDEVs Guidelines
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Medical & IVD Devices Regulations and Standards
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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Medical Software Life Cycle IEC 62304
IEC 62304 – Classification A-B-C
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IEC 62304:
Different
Requirements
for different
Class
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Class
Medical Software Life Cycle IEC 62304
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Medical Software Life Cycle IEC 62304
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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.
Medical & IVD Devices Regulations and Standards
The new Challenge for Medical Professionals
and Patient/Users:
Medical Apps (Mobile Medical Applications)
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Medical & IVD Devices Regulations and Standards
Medical Apps (Mobile Medical Applications)
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Medical & IVD Devices Regulations and Standards
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Medical & IVD Devices Regulations and Standards
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Thanks All for following:
“Regulations and standards for the lifecycle of medical and IVD
Medical & IVD Devices Regulations and Standards
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lifecycle of medical and IVD devices (hardware and software)”