EU regulatory frameworks - Legal challenges and opportunities for digital health innovation

Karin Schulze, Head of Medical Devices at SFL
30 September 2020
DayOne Experts Meeting
Legal challenges and opportunities for digital health innovation
EU regulatory frameworks

CONFIDENTIAL - Copyright © 2020 SFL. All Rights Reservedwww.sfl-services.com 2
SFL - Integrated solutions from development to the market
Products
• Small molecules
• Biologics
• ATMPs
• Medical Devices
• In Vitro Diagnostics
• Combination Products
• Nanomedicines

CONFIDENTIAL - Copyright © 2020 SFL. All Rights Reservedwww.sfl-services.com
• Digital health
• European legislation
• Definitions
• Classification
• Guidance documents
• Standards
• Points to consider
• Take-home messages
3
Agenda

Digital health refers to tools and services utilizing Information and Communication Technologies (ICT) to improve the
prevention, diagnosis, treatment, monitoring and management of health and lifestyle1.
• Very broad covering hardware and software, but with main areas2 including:
4
Digital health
-Health Information Technology (IT) -> eHealth records
-Digital Health Services -> telehealth and telemedicine
-Mobile health (mHealth) -> mobile apps
-Wearables -> sensors and monitoring devices
-Personalized medicine -> -omics/big data analytics, AI/machine
learning
1eHealth: Digital health and care. (2019) European Commission. 2Digital Health. (2020) US FDA.

CONFIDENTIAL - Copyright © 2020 SFL. All Rights Reservedwww.sfl-services.com 5
European Legislation
Medical Devices
Directive
(MDD)
Active Implantable
Medical Devices
Directive
(AIMDD)
In Vitro Diagnostics
Directive
(IVDD)
Medical Devices
Regulation
2017/745
(MDR)
In Vitro Diagnostics
Regulation
2017/746
(IVDR)
4 year transition period
5 year transition period

Generally medical purpose software consists of:
(1) software in a medical device (sometimes referred to as
“embedded” or “part of”)
(2) software as a medical device (SaMD)
Software as a Medical Device
The term “Software as a Medical Device” (SaMD) is defined as
software intended to be used for one or more medical
purposes that perform these purposes without being part of a
hardware medical device.
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf
‘medical device’ means any instrument, apparatus, appliance,
software, material or other article, whether used alone or in
combination, including the software … for the purpose of:
‐ diagnosis, prevention, monitoring, treatment or alleviation of disease,
‐ 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
Classification: (MDD Annex IX)
Stand alone software is considered to be an active medical
device (either class IIa or IIb)1
Software, which drives a device or influences the use of a
device, falls automatically in the same class of the device.
MDD Art. 1(2)
IMDRF -
Software as a Medical Device (SaMD): Key Definitions
6
Overview of definition and classification of MDSW in MDD/IMDRF
1MEDDEV 2.1/6 GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES.

‘in vitro diagnostic medical device’ means any medical device
which is a …, piece of equipment, software or system, … to be
used in vitro for the examination of specimens… for the
purpose of providing information on one or more of the
following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a
disease;
(d) to determine the safety and compatibility with potential
recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures
‘medical device’ means any instrument, apparatus, appliance,
software, implant, reagent, material or other article intended
by the manufacturer to be used, alone or in combination, …
for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis,
treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or
compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy
or of a physiological or pathological process or state,
— providing information by means of in vitro examination of
specimens derived from the human body, including organ,
blood and tissue donations
MDR Art. 2 IVDR Art. 2
7
Overview of definition of MDSW in MDR/IVDR

• Simple data storage (libraries), staff planning or only using simple searches
(NB: a medical image library from patients where the image can be magnified and viewed is MDSW)
• Prognostic, but not intended for decision making
• General health/lifestyle/fitness
• Non-medical purpose
• Not for use with humans or human samples
8
Software not defined as MDSW

Software shall also be deemed to be an active device.
If several classification rules apply to the same device, the rule resulting in the higher classification shall apply.
MDR 2017/745 MDR Annex VIII - Classification
9
Overview of classification of MDSW in MDR
MDSW intended to provide information which is used to take decisions with1: Class
• Take decisions with diagnosis or therapeutic purposes
- May lead to serious deterioration in health or need surgical intervention
- May cause death or irreversible deterioration
IIa
IIb
III
• Monitoring physiological processes
- Monitoring vital physiological parameters where variation could result in
immediate danger
IIa
IIb
• All other software I
• Software driving or influences the use of a medical device Same class as the device
• Software is independent of any other device Classified by its own right

All implementing rules in Annex VIII IVDR shall be considered.
If several classification rules apply to the same device, the rule resulting in the higher classification shall apply.
MDR 2017/746 IVDR Annex VIII - Classification
10
Overview of classification of MDSW in IVDR
IVDR-MDSW intended to provide information from human specimens in vitro: Class
• High personal risk, high public health risk (Rule 1 and 2) D
• High personal risk, moderate to low public health risk (Rule 2-4) C
• Moderate to low personal risk, low public health risk (Rule 4, 6, 7) B
• Low personal risk, low public health risk (Rule 5) A
• Software driving or influences the use of a device Same class as the device
• Software is independent of any other device Classified by its own right

Members: Medical device regulators from Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South
Korea, United States of America
Published first principles and regulatory guidance for Software as a Medical Device (MDSW):
• 2013 - Key Definitions
- Stand-alone software (not part of hardware) intended to be used for medical purposes
• 2014 - Risk Classification
- Medical or healthcare situation (Non-serious, serious, critical)
- Significance of SaMD information (treat/diagnose, drive, inform clinical management)
• 2015 - Quality Management System for SaMDs
- Total Product Lifecycle (TPLC) management system: Leadership/organization with lifecycle, realization and use processes
• 2017 - Clinical Evaluation for SaMDs
- Valid Clinical Association, Analytical Validation and Clinical Validation
• 2020 - Cybersecurity
- TPLC, Information sharing , architecture design principles, threat modelling, security testing, post-market considerations and updates
11
International Medical Device Regulators Forum (IMDRF)
(former Global Harmonization Task Force - GHTF)

MDR defines the establishment of a Medical Device Coordination Group (MDCG).
MDCG provides advice to the Commission and assists the Commission and the Member States in ensuring a
harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746.
Published regulatory MDCG guidance for Software as a Medical Device (MDSW):
• 2019 - Guidance on cybersecurity for medical devices (MDCG 2019-16 rev.1)
• 2019 - Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
(MDCG 2019-11)
• 2020 - Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
(MDCG 2020-1)
• Ongoing - Guidance documents on:
- Legal status of app providers - Q4/2020
- Artificial Intelligence under MDR/IVDR framework - TBD
12
Medical Devices Coordination Group

Standards ensure the MDSW applies state-of-the-art practices when establishing the medical/clinical association,
as well as verifying and validating the performance and safety in development of the MDSW
Harmonized standards
• ISO 14971:2012 - Medical devices — Application of risk management to medical devices (new version 2019)
• ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes
• IEC 62304:2006 - Medical device software — Software life cycle processes (under review)
• IEC 62366:2008 - Medical devices - Part 1: Application of usability engineering to medical devices (new version 2015)
Non-harmonized standards
• ISO 12207:2017 - Systems and software engineering — Software life cycle processes
• Various others dependent on type of software
13
Applicable standards for MDSW

• Cybersecurity
- MDCG 2019-16: Guidance on Cybersecurity for medical devices
- Directive on security of network and information systems (NIS)
• General Data Protection Regulation (GDPR)
• Artificial intelligence regulatory changes foreshadows in recent EU AI1 and data strategy policy2 papers
14
Additional aspects to be considered
1 On Artificial Intelligence - A European approach to excellence and trust, 2 A European strategy for data

• MDD classifies only stand-alone software as active device
• SW classification under MDR and IVDR has changed
• Intended purpose / medical purpose of the device determines if it qualifies as MDSW or IVD MDSW
• MDCG guidances provide decision trees to support determination of MDSW/IVDR-MDSW and classification
• Expected change of classification of many existing digital health devices/software under the new regulations
• Compliance requirements and standards to be considered and applied from the design stage of the device
• Increasing focus on cybersecurity and AI is likely to be reflected in future updates to regulatory frameworks
• GDPR and national legislation on user/consumer rights must be applied
15
Take-home messages

CONFIDENTIAL - Copyright © 2020 Medtech & Pharma Platform. All Rights Reservedwww.medtech-pharma.com
MPP 2020 Virtual Annual Conference
22-23 October 2020
Achieving patient-centricity under the new MDR
- balancing stakeholder interests
www.medtech-pharma.com

office@sfl-services.com
Switzerland • Austria • Germany • Netherlands • UK • US
Thank You
Pharma & Medtech Solutions
 Regulatory Affairs & Quality Assurance
 Medical Affairs & Pharmacovigilance
 Public Affairs & Regulatory Policy
 Reimbursement & Supply Chain
 Legal & Compliance

EU regulatory frameworks - Legal challenges and opportunities for digital health innovation

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to EU regulatory frameworks - Legal challenges and opportunities for digital health innovation

Similar to EU regulatory frameworks - Legal challenges and opportunities for digital health innovation (20)

More from DayOne

More from DayOne (20)

Recently uploaded

Recently uploaded (20)

EU regulatory frameworks - Legal challenges and opportunities for digital health innovation