Medical Apps- when are they medical devices?

Valerie Field– Head of Devices Software/apps

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OVERVIEW

• Pace of new technology

• Types of app/algorithm changing

• Regulation & its challenges.

• New regulation- the differences.

• What it means for me and you?

• Guidance & Help

• Maintaining patient safety

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PACE OF TECHNOLOGY

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TYPE OF TECHNOLOGY

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TYPE OF TECHNOLOGY is Changing

• Multiple Datasets- Big Data

• Exciting new methods and algorithms being developed

will be used as the basis for new software based medical devices including;

• Bioinformatics tools used in clinical genomics

• Apps for dose calculation linked to big data

• Symptom checkers-Triage apps

• Machine Learning/AI- Already becoming a reality

• element of ‘learning from errors’.

• tolerance for errors in healthcare low

• important emphasise transparency and clinical

validation for AI applications designed for

healthcare.

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TYPE OF TECHNOLOGY is Changing

• AI has great potential to transform the UK health and

social care sectors.

• already in use and will continue to grow

• ability to reduce face-to-face time with clinicians

• can be an important part of a care pathway and

patient self-management

• but not without risk

• Transparency on

• How algorithms are continually tested, verified and

clinically validated

• How processes are made understandable to

clinicians to gain support and use.

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WHEN IS SOFTWARE A MEDICAL DEVICE?

• What does the manufacturer claim used for?

• Is this use considered to be a ‘medical purpose’?

• prevent disease/illness

• used for diagnosis

• monitoring

• treatment*

• compensation for an injury or handicap

• Investigation, replacement or modification

• prediction, prognosis

• software intended for life-style and well-being purposes

is not a medical device. http://www.legislation.gov.uk/uksi/2002/618/regulation/2/made

http://www.legislation.gov.uk/uksi/2002/618/regulation/2/made

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Current Regulatory framework

UK Medical Device

Regulations 2002

Medical Device Directive

93/42/EEC

In Vitro Diagnostics

Medical Device Directive 98/79/EC

Active Implantable

Medical Device Directive

90/385/EEC

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NEW Regulatory framework

General and Active

Implantable Medical Device

Regulations

In Vitro Diagnostics

Medical Device Regulation

3 Years 5 Years

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NEW MDR/ IVDR TIMETABLE

2017 2018 2019 2020 2021 2022

EU MDR

Formal

publication

enters into

force

EU IVDR

Formal

publication

enters into

force

EU MDR

Full application

Implementation

3 year transition

period

EU IVDR

Full application

implementation

5 year transition

period

EUDAMED??

The Regulations

entered into force in

May 2017.

However, not

everything will fully

apply until MAY 2020

Medical Devices, and

MAY 2022 for In Vitro

Diagnostic Medical

Devices.

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New Regs-SOFTWARE SPECIFIC CHANGES

14.2(d)…remove as far as possible risks associated with

the possible negative interaction between s/w and the IT

environment within which it operates & interacts.

14.5 Devices that are intended to be operated together

with other devices shall be designed and manufactured in

such a way that the interoperability and compatibility are

reliable and safe

17.1…or software that are devices themselves shall be

designed to ensure repeatability, reliability and

performance in line with their intended use.

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New Regs-SOFTWARE SPECIFIC CHANGES.

17.2 For devices that incorporate software or for software

that are devices in themselves, the software shall be

developed and manufactured in accordance with the state

of the art taking into account the principles of development

life cycle, risk management, including information security,

verification and validation

17.3. Software referred to in this Section that is intended

to be used in combination with mobile computing

platforms shall be designed and manufactured taking into

account the specific features of the mobile platform (e.g.

size and contrast ratio of the screen) and the external

factors related to their use (varying environment as

regards level of light or noise).

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New regs-SOFTWARE SPECIFIC CHANGES.

17.4 Manufacturers shall set out minimum requirements

regarding hardware, IT networks, characteristics and Its

security measures, including protection against

unauthorised access, necessary to run the software as

intended

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New regs-

SOFTWARE NEW CLASSIFICATION RULE 11

• Software intended to provide information which is used

to take decisions with diagnosis or therapeutic

purposes, is in class IIa, except if such decisions have

an impact that may directly or indirectly cause:

• the death or an irreversible deterioration of the state

of health, in which case it is in class III;

• a serious deterioration of the state of health or a

surgical intervention, in which case it is in class IIb.

• Software intended to monitor physiological processes is

in class IIa except if it is……..

• All other software is in class I.

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New Regs-TRACEABILITY – UDI requirements

• Device software

• The UDI shall be assigned at system level of the s/w.

• Only s/w which is commercially available on its own

and s/w which constitutes a device shall be subject

to that requirement.

• Developers

• Allocate UDI – and update for every modification

• Provide data for European UDI database

• Record of who they supplied it to

• Economic operators – (importers, distributors etc.)

• Record of who supplied it and who they supplied it to.

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The Health Institution Exemption

• Regulatory exemption for devices that are manufactured and

used within a single health institution

• Health institutions may manufacture, modify and use a

device ‘in-house’, in order to target a specific need

• Health institution must meet all safety and performance

requirements of the regulations – but will not need notified

body scrutiny or a CE marking

• Will continue in the revised EU regulations

• MHRA continue to partner with stakeholders to update the

guidance on exemptions for health institutions – for greater

reassurance re. safety and performance whilst applying the

exemption in as simple a way as possible

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OTHER KEY CHANGES

Distributors/Importers- to ensure;

• CE marked

• EU declaration of conformity of the device completed

• A manufacturer is identified and that an authorised

representative identified;

• Appropriately labelled

• Where applicable, a UDI has been assigned by the

manufacturer

• Inform the competent authority of any serious risk

All

• Establish and update a clinical evaluation plan

• Conduct Post-Market clinical follow-up

• Centralised European database (EUDAMED) to capture data

on CE certificates, incidents, clinical investigations, market

surveillance etc.

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Registration of Class 1 device manufacturers

• Registration only – Not approval

• £100.00

• Self-declare conformity

• Details appear on the publicly accessible database

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General guidance already issued

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So what are your challenges?

• Recognising medical device apps/software

• Changes to in-house exemption rules

• Current class 1 software developers to check if their

devices are going to be ‘up classified’ in the MDR /IVDR

such that they will need a Notified Body.

• Engaging Notified Bodies

• UDI requirements

• Increased post market surveillance requirements

• Reporting requirements

https://yellowcard.mhra.gov.uk/

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CHALLENGES – for MHRA

• MDR/IVDR- Work with EU on agreeing interpretation and

implementation of the changes, update of MEDDEV 2.1/6

• International approaches- IMDRF, FDA & others

• Informing developers/ manufacturers of what these changes mean

for them

• Working with Notified Bodies on being ready for the changes

• Engage with the major app stores to let them know what the

requirements will be for importers and distributors.

• How do we ensure verification/clinical validation especially for

Machine learning algorithms.

• Update our software guidance in appropriate timescale

• Ensuring those messages relayed and understood by all involved.

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Example—-Social media signal

MHRA made aware that a company was allegedly

contacting ambulatory insulin pump users with type 1

diabetes through social media and asking them to switch

to their product!!

Issued a generic Medical Device Alert 2016/020 and an

associated press release

“Managing diabetes: patients should not change their

insulin delivery device without checking with their

healthcare specialist and should report such approaches”

.

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Example app calculation

Report of an app associated with a blood glucose meter used to

determine insulin dose

Issue

• When used with a secondary mobile device [phone or tablet] it was

not downloading information correctly from the cloud database.

• Data on blood glucose meter and primary mobile device not

affected.

• Implications could be extremely serious

Action

• Reported to MHRA

• Company issued Field Safety Notice to customers

• Cloud synchronisation disabled and new software version

developed

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Example

Article published in health publication undertaken by a UK university

Issue

• Article claimed the majority of 40+ ‘stand alone’ insulin dosing

apps they tested were unreliable and put patients at risk of

incorrect doses of insulin

Action

• MHRA liaised with authors of study at university

• All university findings supplied to us

• All issues identified were passed to our compliance unit

• All cases not CE marked or evidence to suggest error investigated

• All UK based apps brought into compliance or removed from

market

• Liaison with organisations to be aware.

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How can we help each other?

MHRA Innovation Office;

Innovationoffice@mhra.gsi.gov.uk

Devices Regulatory Enquiries;

Devices.Regulatory@mhra.gsi.gov.uk

Register your devices;

https://www.gov.uk/guidance/medical-devices-how-to-comply-with-

the-legal-requirements

Report issues to us;

https://yellowcard.mhra.gov.uk

mailto:Devices.Regulatory@mhra.gsi.gov.ukhttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirementshttps://yellowcard.mhra.gov.uk/

Please note that whilst we are willing to give any help and advice we can, any views given by us on the interpretation of the Regulations represent our best judgement at the time, based on the information available. Such views are not meant to be a definitive statement of law, which may only be given by the Courts. Accordingly we would always advise you to seek the views of your own professional advisors.

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Any Questions?

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