This document summarizes a presentation given on developments in EU medical device software regulation. It discusses the current regulation of medical device and in vitro diagnostic software under the EU Medical Devices Directives. It outlines proposals to revise these directives, including redefining medical devices and establishing new essential requirements for software. It also notes enforcement developments in the Netherlands, such as the health authority indicating it will impose fines without warning for non-compliant software beginning in 2014.
Presentation at the yearly Regulanet conference about application of EU data protection rules to medical devices and end-to-end solutions incorporating medical devices.
Presentation at the yearly Regulanet conference about application of EU data protection rules to medical devices and end-to-end solutions incorporating medical devices.
EU cybersecurity requirements under current and future medical devices regula...Erik Vollebregt
Presentation delivered at Q1 MEDICAL DEVICE CYBERSECURITY RISK MITIGATION conference in Washington on 25 July 2016 concerning EU cybersecurity requirements under current and future medical devices regulation
Use of left over samples under the IVDR and GDPRErik Vollebregt
Presentation on the RAPS Convergence 2017 about the use of left over samples in performance evaluation under the In Vitro Diagnostics Regulation (IVDR) and under the General Data Protection Regulation (GDPR)
EU General Data Protection Regulation top 8 operational impacts in personal c...Erik Vollebregt
Presentation to the Personal Connected Health Alliance about the top 8 operational impacts of the EU General Data Protection Regulation on companies in the personal connected health field.
EU Medical Device Clinical Research under the General Data Protection RegulationErik Vollebregt
Presentation about medical devices patient data management under the EU General Data Protection Regulation at the Medical Device Clinical Research Conference in November 2015
Presentation at the 29-30 January 2014 Informa Medical Devices Revision conference in Brussels regarding developments in relation to the Eudamed database and its rule in the new EU medical devices system
Presentation about transparency under the new MDR and IVDR at Informa Medtech Summit in Clinical evaluations and investigations for medical devices track
eHealth - Medical Systems Interoperability & Mobile Healthulmedical
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices.
This webinar was presented by UL eHealth experts on October 30, 2013.
EU data protection and security update COCIR annual meeting 2016Erik Vollebregt
Presentation at the COCIR annual meeting on 17 March 2016 regarding the top 7 operational impacts of the new EU General Data Protection Regulation for health IT companies.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
An eHealth suite for the support of Primary Health Care.
Athena Triantafyllidi, IT Director at IDIKA explains the developments behind the eGov organisation for Social Security and what led them to be considered one of the leading European examples in implementing a digital reference for all those living in Greece.
Twitter: @idikagr
Presentation: Device vigilance - local challenges & global trendsTGA Australia
This session will examine some of the hot topic in this areas including a presentation from TGA covering some of the challenges they are seeing locally as well as an industry perspective on global hot topics and trends in device vigilance
EU cybersecurity requirements under current and future medical devices regula...Erik Vollebregt
Presentation delivered at Q1 MEDICAL DEVICE CYBERSECURITY RISK MITIGATION conference in Washington on 25 July 2016 concerning EU cybersecurity requirements under current and future medical devices regulation
Use of left over samples under the IVDR and GDPRErik Vollebregt
Presentation on the RAPS Convergence 2017 about the use of left over samples in performance evaluation under the In Vitro Diagnostics Regulation (IVDR) and under the General Data Protection Regulation (GDPR)
EU General Data Protection Regulation top 8 operational impacts in personal c...Erik Vollebregt
Presentation to the Personal Connected Health Alliance about the top 8 operational impacts of the EU General Data Protection Regulation on companies in the personal connected health field.
EU Medical Device Clinical Research under the General Data Protection RegulationErik Vollebregt
Presentation about medical devices patient data management under the EU General Data Protection Regulation at the Medical Device Clinical Research Conference in November 2015
Presentation at the 29-30 January 2014 Informa Medical Devices Revision conference in Brussels regarding developments in relation to the Eudamed database and its rule in the new EU medical devices system
Presentation about transparency under the new MDR and IVDR at Informa Medtech Summit in Clinical evaluations and investigations for medical devices track
eHealth - Medical Systems Interoperability & Mobile Healthulmedical
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices.
This webinar was presented by UL eHealth experts on October 30, 2013.
EU data protection and security update COCIR annual meeting 2016Erik Vollebregt
Presentation at the COCIR annual meeting on 17 March 2016 regarding the top 7 operational impacts of the new EU General Data Protection Regulation for health IT companies.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times.
But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare?
In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare.
About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.
About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
An eHealth suite for the support of Primary Health Care.
Athena Triantafyllidi, IT Director at IDIKA explains the developments behind the eGov organisation for Social Security and what led them to be considered one of the leading European examples in implementing a digital reference for all those living in Greece.
Twitter: @idikagr
Presentation: Device vigilance - local challenges & global trendsTGA Australia
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Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
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'Connected healthcare - connected to legality?'Lucy Woods
In January 2016, we held a Legal SIG (special interest group) at the London HQ of Olswang. Speakers included Juma El-Awaisi of Braci, Ross McKean of Olswang and Ken Munro of Pen Test Partners. Ken's presentation was interactive so slides are coming soon!
"The value of a European approach to mHealth in cancer Unleashing the mHealth...3GDR
The value of a European approach to mHealth in cancer
Unleashing the mHealth potential for cancer patients
Pēteris Zilgalvis
Head of Unit Health and Wellbeing
DG Communications Networks, Content and Technology
Peteris Zilgalvis, Head of the Health & Wellbeing Unit, European Commission, DG
-----
This was presented at the "Unleashing the mHealth potential for cancer patients" event held on Wednesday 25th May 2016 (16:30-18:30pm) in the European Parliament.
#mHealthCancer
"mHealth and eHealth are becoming realities in Europe: this is demonstrated by the growing size of mHealth apps’ market, by the raising investments in eHealth infrastructures and by the fast adoption, at various degrees, of mHealth applications by patients.
The burden of cancer is also raising: more than 10 million EU citizens are affected by cancer, incidence and prevalence are growing, and the socio-economic impact of cancer heavily burdens both healthcare systems and cancer patients.
The recent political agreement on the text the General Data Protection Regulation and the production of the Privacy Code of Conduct mHealth apps further stir the debate regarding the use of new mHealth technologies within cancer care pathways.
Are cancer patients enjoying the benefits of mHealth?
In which field can cancer patients profit the most from mHealth apps?
Is the regulatory framework supporting the development of useful and safe mHealth apps for cancer patients?
Are there other structural obstacles to the full integration of mHealth apps in the cancer patients’ journey?"
The event will be hosted by MEP Cristian-Silviu Busoi (EPP, Romania), one of ECPC closest champions within the European Parliament and a knowledgeable supporter of the development of eHealth/mHealth in Europe.
The event was followed by a cocktail reception.
Join the discussion on Twitter using #mHealthCancer The event is part of the initiatives for the
2016 European Week Against Cancer #EWAC2016
More information can be found on the European Cancer Patient Coalition's website:
http://www.ecpc.org/pressroom/events/icalrepeat.detail/2016/04/26/61/-/-
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
GDPR challenges for the healthcare sector and the practical steps to complianceIT Governance Ltd
This webinar covers:
- An overview of the General Data Protection Regulation (GPDR) and the Data Security and Protection (DSP) Toolkit and their impact on the healthcare sector.
-Accountability frameworks that support GDPR compliance, and the role of senior management in ensuring compliance and cyber resilience is a strategic focus.
-Embedding data protection by design and by default, and a holistic approach to achieving a cyber resilient posture.
-The practical steps that healthcare organisations need to take when looking at GDPR compliance.
-The role of a robust staff awareness programme in supporting a culture of cyber resilience and compliance.
A recording of the webinar can be found here: https://www.youtube.com/watch?v=xFEkkkwAdl4
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
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Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
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Software and Smartphone Applications By E. Vollebregt - Axon Lawers (Qserve Conference 2013)
1. DEVELOPMENTS IN
EU MDD & IVDD
SOFTWARE
REGULATION
Qserve conference
18 November 2013
Erik Vollebregt
www.axonlawyers.com
2. Objectives
•
•
•
•
Some brief remarks on data protection
Current regulation of medical devices software
Overview of EU medical devices directives revision process
Developments in enforcement in the Netherlands
3. EU political background
eHealth Action Plan 2012 – 2020
• Struggles with Lisbon competences (“EU action shall respect the
responsibilities of the Member States for the definition of their health
policy and for the organisation and delivery of health services and
medical care.”)
Pretty big changes in
• Regulation of medicinal products and medical devices / IVDs
• Regulation of collection and processing of health data
3
4. Health data protection
• Currently in flux with General Data Protection Regulation proposal
• Horizontal approach to all data causes excessive collateral damage in
healthcare sector
• What we hate in marketing and social media, we actually want in
healthcare (e.g. monitoring, profiling, further processing, traceability)
• Privacy-by-design requirements
• Privacy impact assessments
• Consent requirements that make it very difficult to rely on consent as
basis for processing
4
5. General Data Protection
Regulation
• Privacy by design
• Prior approval of impact assessment of each act of processing
• Literally – Parliament proposes that software and devices have to be
designed and built as to enable GDPR and data subject’s rights by
default
• Intelligible explanation of automated processing logic
• Exemptions for processing of health data without consent
• With uncertainties around concept of ‘consent’ derogations for “public
health” and “scientific purposes” become crucial
• Exemptions not suited for outsourced processing in eHealth / mHealth
services and not drafted for regulatory clinical data obligations
• Technical standards
• Commission can issue technical standards related to implementation
of GDPR requirements
5
6. General Data Protection
Regulation
• Data subject’s rights
• Right to correct, information, be forgotten and of erasure problematic
in clinical context
• Right to request interoperable and open source format copy of
processed data
• Company burden
• Mandatory privacy officer
• Large fines
• Many open ends still that are subject to implementation by implementing
act or regulation by delegated act
• Commission is not obliged to use these powers and EU legislator may
change the scope or revoke power, which increases uncertainty
6
7. Regulation of software as MD / IVD
• MEDDEV 2.1/6 on standalone software, currently under revision
• Differences in interpretation of what software constitutes a medical
device
• New essential requirements for mobile computing platform
• EN 62304 standard FAQ by Team NB
• Lack of harmonised interoperability standards
7
8. MEDDEV 2.1/6
medical devices
simple version
1. Computer program?
2. Stand alone?
3. What action does it perform on
data? [beyond storage, archival,
lossless compression, simple
search]
4. For benefit of individual
patients?
5. Intended purpose in scope of
MDD?
6. Accessory?
9. MEDDEV 2.1/6 IVDs
simple version
1. In scope MDD?
2. In scope IVDD?
3. Data obtained only from
IVD?
4. Data obtained from
medical device?
5. Accessory?
6. Accessory?
12. Essential requirements
New essential requirements re software in MDR
11.2. Devices shall be designed and manufactured in such a way as to
remove or reduce as far as possible and appropriate:
• (e) the risk associated with the possible negative interaction between
software and the environment within which it operates and interacts;
12
14. Software clinical
6.1. Pre-clinical and clinical data
(b) detailed information regarding test design, complete test or study
protocols, methods of data analysis, in addition to data summaries and test
conclusions regarding:
• software verification and validation (describing the software design and
development process and evidence of the validation of the software, as
used in the finished device. This information should typically include the
summary results of all verification, validation and testing performed both
in-house and in a simulated or actual user environment prior to final
release. It should also address all of the different hardware
configurations and, where applicable, operating systems identified in the
information supplied by the manufacturer);
14
15. Recommendation on
unannounced audits
• Requires manufacturers to amend agreement with NoBo to
accommodate all aspects of unannounced audits (visa, security etc)
• Requires manufacturers to better manage agreements with
• Critical subcontractors
• Critical suppliers
• Critical suppliers and subcontractors must be able to accommodate an
unannounced audits
• Manufacturers must
• integrate the quality system of critical subcontractors and of crucial
suppliers with their quality system;
• control the quality of services provided and of components supplied
and the quality of production thereof regardless of the length of the
contractual chain between the manufacturer and the subcontractor or
supplier.
16. Enforcement
2013:
• 5 June and 2 October: invitational conferences held
by Dutch Health Inspectorate (IGZ):
• As of 1 January 2014 IGZ will enforce medical
devices law against medical software that they
consider a medical device
• IGZ started collecting information from the market
• Enforcement capacity expansion with 25 inspectors
• Revision of enforcement policy
18. IGZ will impose fines without
warning as of 1 January 2014
For example: making a non-CE marked app or software available – could
lead to an immediate fine of € 450.000
19. THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
READ MY BLOG:
http://medicaldeviceslegal.com
Qserve conference
18 November 2013
www.axonlawyers.com
20. Legal stuff
• The information in this presentation is provided for information purposes only.
• The information is not exhaustive. While every endeavour is made to ensure
that the information is correct at the time of publication, the legal position may
change as a result of matters including new legislative developments, new
case law, local implementation variations or other developments.
• The information does not take into account the specifics of any person's
position and may be wholly inappropriate for your particular circumstances.
• The information is not intended to be legal advice, cannot be relied on as
legal advice and should not be a substitute for legal advice.