Standalone software and medical device regulation

1. Standalone software and
medical device regulation
Future Health Summit
27th May 2016
Cathal Brennan
Medical Device Assessor

2. To protect and enhance public and animal
health through the regulation of medicine,
medical devices and healthcare products

3. Our Role

4. General medical devices
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5. Active Implantable Medical Devices
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6. In-vitro diagnostic devices
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9. Stand alone software
‘Stand alone software’ means software which is not incorporated in a medical device at the
time of its placing on the market or its making available.
Directive 2007/47/EC amended the definition of the term "medical device" used in
Directives 90/385/EEC and 93/42/EEC.
Recital 6 of Directive 2007/47/EC states that "it is necessary to clarify that software in its own
right, when specifically intended by the manufacturer to be used for one or more of the
medical purposes set out in the definition of a medical device, is a medical device. Stand alone
software for general purposes when used in a healthcare setting is not a medical device.“
Stand alone software shall be qualified as an in vitro diagnostic (IVD) medical device or as an
accessory to an IVD provided that it satisfies the definition of an IVD or of an accessory to an
IVD as set out in Directive 98/79/EC4.
Slide
Classification of Medical Devices

10. Qualification
MEDDEV 2.1/6
• Is it a computer programme?
• Incorporated into a MD?
• Does it perform an action of
data?
• For the benefit of individual
patients?
• For purposes defined in 1.2a of
MDD?
Slide 10

11. If standalone SW qualifies as an MD….
• Determine which legislation applies
• Ensure compliance before placing on market
• If in doubt, seek advice on regulatory
requirements
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12. Proportionate regulation
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Classification Risk Example
III Complex joint implant,
drug eluting stents (DES),
coronary valve
IIb Peripheral Bare Metal
Stents (BMS),
IIa Contact lenses (short-
term), ECG machines,
electronic BP monitors
I Wheelchairs, simple
wound dressings,
Stethoscopes, ECG
electrodes, syringes
• pre-market requirements
• conformity assessment route
• clinical data requirements
• post-market obligations

13. The Essential Requirements aim to ensure medical devices are designed, manufactured and
used such that unnecessary risks to patients and users are avoided.
13 Essential Requirements made up of 79 parts covering:
Essential Requirements
Slide
PerformanceManufacture
LabellingUsability
Design

14. Essential Requirements 1 “devices must be designed and manufactured in such a way
that….they will not compromise the clinical condition or the safety of patients, or
the safety and health of users or, where applicable, other persons, provided that any risks
which may be associated with their intended use constitute acceptable risks when weighed
against the benefits to the patient and are compatible with a high level of protection of health
and safety”
ER2 states that “solutions adopted by the manufacturer for the design and construction of the
devices must conform to safety principles, taking account of the generally acknowledged state
of the art. In selecting the most appropriate solutions, the manufacturer must apply the
following principles in the following order:
— eliminate or reduce risks as far as possible (inherently safe design and construction),
— where appropriate take adequate protection measures including alarms if necessary, in
relation to risks that cannot be eliminated,
— inform users of the residual risks due to any shortcomings of the protection measures
adopted.
Essential Requirements
Slide

15. Essential Requirements 9.1 “if the device is intended for use in
combination with other devices or equipment, the whole combination,
including the connection system must be safe and must not impair of the
devices. Any restrictions on use must be indicated on the label or in the
instructions for use”
Essential Requirement 12.1a “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.”
Essential Requirements
Slide

16. European harmonised standards:
• Provide corresponding technical specifications for meeting the Essential
Requirements
• Non-mandatory
• Alternate methods for meeting the requirements of the directives are possible, but
obligation to demonstrate conformance
• Relevant standards for standalone software:
• IEC 62304 Medical devices software – software lifecycle processes
• EN ISO 14971 Risk Management
• ISO 13485 Medical devices - Quality management systems
Harmonised Standards
Slide

17. CE Marking – Conformity Assessment
Class I medical devices are self-
declared by the manufacturer with the
exception of Class I medical devices
which are sterile and/or have a
measuring function; a notified body is
required to asses the sterility or
measuring aspect only of these
devices.
CLASS I
Non-sterile/
Non-Measuring
CLASS I
Sterile/
Measuring
CLASS IIa CLASS IIb CLASS III
Quality Management System (QMS)
Technical File
Design
Dossier
QMS and Technical File/Design Dossier audited by
Notified Body
CE Certificate awarded
Registration with
Competent Authority
(CA)
In general, registration is not required.
CA may request information when
placed on market
Draw up Declaration of Conformity (DOC)
1234 1234 12341234
Slide

18. CE Marking – Conformity Assessment
Third party conformity assessment is
carried out by notified bodies
Approximately 60 in Europe; e.g. NSAI,
BSI, TUV
Conformity Assessment routes laid out
in Article 11: Class IIa, IIb and III
CLASS I
Non-sterile/
Non-Measuring
CLASS I
Sterile/
Measuring
CLASS IIa CLASS IIb CLASS III
Quality Management System (QMS)
Technical File
Design
Dossier
QMS and Technical File/Design Dossier audited by
Notified Body
CE Certificate awarded
Registration with
Competent Authority
(CA)
In general, registration is not required.
CA may request information when
placed on market
Draw up Declaration of Conformity (DOC)
1234 1234 12341234
Slide 18

19. Registration
19
CLASS I
Non-sterile/
Non-Measuring
CLASS I
Sterile/
Measuring
System and
Procedure
Packs
Custom-
made
devices
Quality Management System (QMS)
Technical File
Design
Dossier
QMS and Technical File/Design Dossier audited by Notified
Body
CE Certificate awarded
Registration with
Competent Authority (CA)
In general, registration is not required.
CA may request information when placed
on market
Draw up Declaration of Conformity (DOC)
1234 1234 12341234
All Classes
of IVDs Manufacturers, or their authorised
representatives, who have a registered
place of business in Ireland must
register with the HPRA if they place
certain classes of medical devices on
the Irish/European market:
• Class 1
• System & procedure packs
• Custom made
• IVD’s
Pro-active audits of these registered
organisations are routinely carried out
by the HPRA to ensure they meet the
requirements of the medical device
directives.

20. Post market surveillance
• The manufacturer shall institute and keep up to date a
systematic procedure to review experience gained from devices
in the post-production phase, including the provisions referred
to in Annex X, and to implement appropriate means to apply
any necessary corrective actions, taking account of the nature
and risks in relation to the product.
• To notify the competent authorities of:
Any malfunction, failure or deterioration in the characteristics
and/or performance of a device, as well as any inadequacy in
the labelling or the instructions for use which, directly or
indirectly, might lead to, or might have led to, the death of a
patient or user or other persons or to a serious deterioration in
his or her state of health
• Standalone software by its nature often leads to INDIRECT Harm
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The role of the HPRA

22. Changes to legislation
• Why?
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Standalone software & the HPRA
Qualification
Clinical
investigations
Guidance
Classification Registration

24. Advice for manufacturers
• Consider Regulations at an early stage
• Ensure compliance with legislation:
– Assess whether your standalone software qualifies as medical device
– Ensure it is classified correctly
– Follow appropriate conformity assessment
– Comply with Essential Requirements
– Technical documentation
– Register with the HPRA, if required
– Post market surveillance and vigilance system …………
• Get advise – experience with medical device SW
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25. Advice for users
• Consider the different standalone software you use
– Is it a medical device?
– If so, is it CE marked?
• Report any incidents to the manufacturer and the HPRA
• Report any non-complying product to the HPRA
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26. Thank you
Cathal Brennan
Medical Device Assessor
Human Products Authorisation and Registration Department
Tel: +353 1 676 4971
Fax: +353 1 676 7836
devices@hpra.ie
www.hpra.ie

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