Software as a Medical Device
Challenges and Supports
Chrissie Keane
Standards Officer, NSAI, Healthcare
Software as a Medical Device
Challenges and Supports
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Regulation of Medical Devices
Software as a Medical Device
Challenges to Industry
Support from Standards
What standards are relevant
Keeping Informed..
0050
Software as a Medical Device
Challenges and Supports
CE Mark•Legally required before
‘placing on the market
•Assures compliance with
Regulatory requirements
•Defined responsibility
•Not foolproof… (PIP)
0050
Software as a Medical Device
Challenges and Supports
Software
as a
Medical
Device
Not easily
Defined
Challenge
to
Regulators
Software as a Medical Device
Challenges and Supports
• Legal requirement to CE Mark
Software was March 2010
• MDEG (Medical Devices Expert
Group) finally issued guidelines for
Classification of Software in
January 2012
• Scarcely implemented
CE Mark: Assuring Product Safety
In a nutshell……..
• Define and Classify device according to MDD
• Product (design) must be proven to meet
Essential (safety)Requirements
• Production process must assure consistency and
compliance with approved design, (Quality
Assurance)
• Independent reliable 3rd party regulation
(Notified Body or Competent Authority)
Software as a Medical Device
Challenges and Supports
When IS Software a ‘Medical Device?’
?
• First must meet the definition of a
Medical Device
• Classification Rules apply
NSAI Product Approval
- Definition – “Medical Device”
-
means any instrument, apparatus, appliance, material or other article, whether
used alone or in combination, including the software necessary for its proper
application intended by the manufacturer to be used on human beings for the
purpose of:
•DIAGNOSIS, PREVENTION, MONITORING, TREATMENT or ALLEVIATION of
DISEASE
•DIAGNOSIS, MONITORING, TREATMENT, ALLEVIATION 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
Definition of a Medical Device
(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;
This Directive shall apply to medical devices and
their accessories.
For the purposes of this Directive, accessories shall be treated
as medical devices in their own right.
Both medical devices and accessories shall hereinafter
be termed devices.
Classification of Software as Med. Device
From the Directive…..
►M5 Stand alone software is considered to be
an active medical device. ◄
2. Implementing rules
2.1. Application of the classification rules shall be
governed by the intended purpose of the devices.
2.2. If the device is intended to be used in combination
with another device, the classification rules shall apply
separately to each of the devices.
Accessories are classified in their own right separately
from the device with which they are used.
2.3. Software, which drives a device or influences the
use of a device, falls automatically in the same class.
Classification rules and guidance
Q1. Is the software a computer program?
• No The software does not contain instructions
or subroutines in a particular programming
language. Not a Medical Device
• Yes, proceed to Q2
• Q2. Is the software embedded in a medical
device?
• Yes, it’s part of a device… proceed for device
• No, It’s Stand alone software…Proceed Q3
• Q3. Is the software performing an action on
data different from storage archival, lossless
compression, communication or simple search?
• No…. Not a Medical Device
• Yes Proceed Q4
Classification rules and guidance
Q4. Is the action for the benefit of
individual patients?
• No, e.g. software for statistical
evaluation of clinical studies or
epidemiological studies or registers?
• No…. Not a Medical Device
• Yes Proceed Q5
Q5. is the action for the purposes
defined in art 1.2a of the MDD?
• Yes…. It’s covered by the MDD
• No…. Not a Medical Device
Classification rules and guidance
Q6. Is it an accessory of a medical device?
• Yes such as software driving, monitoring
performance of, or influencing
performance or the use of a medical
device….. then it’s covered by the MDD
• No, e.g. the software performs an action
on data for financial reimbursement, staff
scheduling , resource management or
other non-medical purposes
Not covered by the MDD
Standalone software
1.Does it meet the
definition of a MD?
No
Not covered by the MDD
Yes
2.
Providing information
within the scope of the
IVD definition?
No
Yes
MDD
3. Expert function?
Yes
Yes
5. Data only from
medical device?
No
4. Data
obtained only from
IVD?
6. Is it
an accessory of an
IVD?
No
No
Combination of data
coming from IVD and
MD
Yes
Yes
IVDD
Yes
No
MDD
Technical documentation requirements
• All routes to CE marking require
technical documentation
• Records to show proof of compliance
with Essential Requirements and other
annex requirements
• Read Annex carefully
• Maintain up-to-date
• Maintain checklist to records of compliance
Software as a Medical Device
Challenges and Supports
• Little policing of the regulation
• Little demand from purchasers
• Lack of standards to support software
development and validation
• Much software needs to be integrated
‘in-house’
• Risk needs to be managed
Software as a Medical Device
Challenges and Supports
• EU Directives specify the Essential Requirements,
without specifying how it should be achieved...
• Conformity assessment policy:
• Products that conform to relevant Harmonised
Standards must be presumed to conform to
relevant legal directive requirements. (Article 5)
• Benefits
• Standards bring transparency and definition to
the means of compliance.
Software as a Medical Device
Challenges and Supports
• Standards are being developed to
support manufacturers in
proving regulatory compliance
• Standards are being developed to
support management of
Networks within Hospitals
Pushed by
Regulation
Use of and
compliance
with
Standards
Pulled and
demanded
by
Purchasers
E.g. Average Medical Device complies with many standards
•Biocompatibility
•Endotracheal tube
•15mm connector
•Luer fitting
•QMS, 13485
•Cleanroom
•Labelling
•Sterilisation
•ETO residuals
•Packaging
Software as a Medical Device
Challenges and Supports
ISO/DTR 17791 Health informatics - Guidance on Standards for
Enabling Safety in Health Software
IEC 62304:2006 Medical device software. Software life-cycle
processes (also IEC 82304)
IEC/TR 80002-1 Guidance on the application of ISO 14971 to medical
device software
ISO/TR 11633-1:2009Health informatics -- Information security
management for remote maintenance of medical devices and
medical information systems -- Part 1: Requirements and risk
analysis
ISO/DTS 13131 Health Informatics -- Quality criteria for services and
systems for telehealth.
Software as a Medical Device
Challenges and Supports
IEC 80001-1:2010 Application of risk management for ITnetworks incorporating medical devices -- Part 1:
Roles, responsibilities and activities
IEC/TR 80001-2-1:2012 Part 2-1: Step by Step Risk
Management of Medical IT-Networks; Practical
Applications and Examples
IEC/TR 80001-2-3:2012Part 2-3: Guidance for wireless
networks
IEC/TR 80001-2-4:2012 Part 2-4:General implementation
guidance for Healthcare Delivery Organizations
Software as a Medical Device
Challenges and Supports
ISO/IEEE 11073-10404:2010 Health informatics -Personal health device communication –
Part 10404: Device specialization -- Pulse oximeter
Part 10471: Independant living activity hub
Part 10472: Medication monitor
Part 10421: Peak expiratory flow monitor (peak flow)
Part 10420: Body composition analyzer
Part 10417: Glucose meter
Part 10408: Thermometer
Part 10407: Blood pressure monitor..........
Standards assessment map (covering clauses 5.1.1 to 5.1.12, but excluding 5.1.12)
Software as a Medical Device
Challenges and Supports
e.g. NSAI/HISC role in Standards
CC structure
• Chairman:
usually from industry/Clinic
• Secretary:
from NSAI
• Membership:
broad representation from
Industry, Clinicians, Users, Health
interests, public bodies, technical
expertise, educational bodies, as
appropriate
Software as a Medical Device
Challenges and Supports
NSAI
HISC
Subject
Mirroring
work on
CEN TC 251
Mirroring
work on
ISO TC 215
CEN TC 251
WG 1
ISO TC 215
WG 1
SC 1
EHR Architecture and
Information Models
SC 2
Nursing and Health Terminology CEN TC 251 WG ISO TC 215
2
WG 3
SC 3
SC 4
Network Management, including CEN TC 251 WG
interoperability, security and
4
safety
Pharmacy
---
SC 5
Medical Device Software
ISO TC 215
WGs 2 , 4, and
JWG 7
ISO TC 215
WG 6
Work emerging from IEC TC 62A
NSAI/ETCI are the conduit… the horizon
scanners who trawl the international waters
for work relevant to Irish interests.
IS
EN
Edible?
Useful to Ireland
Approve
Inedible?
Toxic Fish
No relevance to
Ireland, Abstain
Standard could be a danger
Or barrier to Irish industry
Reject
Who writes Standards....? You do!
ISO TC
215
Produce
documents
for review
ISO TC
215
Compile
votes and
publishes
new
standard
NSAI/ETCI/
HISC Access
documents on ISO
site
NSAI’s HISC
Balance of Experts
submits comments
on content of Std.
Reviews Work
Submits Vote
All contributions welcome
Technology races ahead……
Standards are beginning to move…..
Regulation is still crawling……….
Software as a Medical Device
Challenges and Supports
In Summary……
• Health software may be a Medical Device
• If it is, it must be CE marked
• Standards exist to support the CE
marking process
Software as a Medical Device
Challenges and Supports
Don't ignore standards....
They’re not going away!
• www.standards.ie
• [email protected]
Thank you