ISPOR Workshop #5784 Presentation W17
Session VII
NEW CHALLENGES FOR HIGH-RISK
MEDICAL DEVICES IN EUROPE: HOW
TO ACHIEVE THE BALANCE BETWEEN
THE DEMAND FOR EARLY PRODUCT
LAUNCH AND SAFETY?
1 Nov 2016: 15:15-16:15
Introduction
Jenifer Ehreth, PhD, MHA
Senior Consultant, LASER Analytica
Jenifer is a US citizen and has 15 years’ experience in the industry with pharmaceuticals, medical devices, vaccines and
orphan disease in different roles from Head to Vice President of Health Economics, Market Access and Pricing in the
USA and Europe. She has also continued as a part-time university professor of health economics in Switzerland. She
joined LASER in 2011 as an exclusive consultant
Bernard Avouac, MD
Bernard is consultant in market access and reimbursement. Earlier in his career he worked as a Consultant
rheumatologist at the Hospital Henri Mondor. He is also a visiting professor of epidemiology and public health at the
Université de Liège. Dr. Avouac has published several high impact manuscripts in the fields of pharmacology and
health economy. Dr Avouac has been an active member of several drug appraisal committees at the Agence du
Médicament and also at the AFSSAPS in France. He is former President of the Transparency Committee in France
which provides advice to the Ministry of Health and Social Affairs for drug listing and pricing. He was a member of the
Medical Device reimbursement committee at the HAS as representative of Devices Industry (SNITEM).
Rosanna Tarricone
Rosanna Tarricone is Associate Professor in Public Administration at Bocconi University, Milan and Director of the
Centre for Research on Health and Social Care (CeRGAS). She graduated in Business Administration at Bocconi
University and holds an MSc in Health Services Management and PhD in Public Health, both from the London
School of Hygiene and Tropical Medicine, University of London, UK. Her main areas of research are: health care
management, economic analysis of health care services, health policy and health technology assessment (HTA).
Rosanna is member of the Board of Directors of ISPOR.
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Katerina Zakrzewska, PhD
Katerina is the head of Market Access, Tender, Pricing, Gov Affairs and Medical Affairs for the Johnson & Johnson
Diabetes Franchise in EMEA. Katerina jointed J&J in 2009 as lead for Ethicon. Before joining J&J, Katerina
occupied positions in Market Access, in Regional, Global and Country roles. She has both pharmaceutical and
medical device experience. Throughout her career she was responsible for Market Access & Policy strategies for
8 Therapeutic Areas.
Kurt Neeser, PhD, MPH
Kurt Neeser is Director at LASER ANALYTICA in Germany with a focus on Health Technology Assessment
(HTA), development of disease models and economic evaluations for medical devices and pharmaceuticals. He
has a PhD in veterinary medicine and a Master in Public Health and gained 20 years of experience in the field of
outcomes research.
EU Council and Parliamentary Committees
> New Medical Device and IVD Regulations
• 15 June 2016 committees signed-off
• End of 2016 adoption and publication
• 3 years before rules will apply
> Foci
• Design
• Manufacture
• Testing
• Authorisation
• Post-market surveillance
http://raps.org/Regulatory-Focus/News/2016/06/15/25142/EU-Council-and-ParliamentaryCommittees-Sign-Off-on-New-Medical-Device-IVD-Regulations/
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Intended changes
Today
AIMD
(90/385/EWG)
Future
MDD
(93/42/EWG)
MDR
IVD
98/79/EWG
IVDR
AIMD: Active Implantable Medical Devices; MDD: Medical Device Directive; IVD: In-vitro Diagnostics Devices
Directive; MDR: Medical Device Regulation: IVDR: In Vitro Diagnostic Medical Devices Regulation
Key Provisions
> High risk devices, such as implants, joint
replacements or insulin pumps, will be subject
to additional assessments by experts before
they can be authorised
> Stricter requirements for notified bodies
> Clinical performance and benefits
> Stronger pre-market scrutiny and postmarketing surveillance
> Increased transparency and traceability
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More specific provisions
> Single use device reprocessing only where
national laws ensure safety. Member States
must comply with EU safety guidelines.
> No rule on genetic testing as it is a Member
State jurisdiction.The rule was to mandate
that the results must be provided to the
patient with explanation of implications.
> All manufacturers must establish risk and
quality management systems except Class I
self-certified devices
Quantification of benefit to patients
Types of benefits:
• pre-identified health threshold was achieved
• change in subjects’ condition or clinical management as
measured on a scale
• variation in the magnitude of the benefit across a population
• clinical relevance of these changes should be discussed and
justified
• in certain cases benefits can be assumed when validated
surrogate endpoints are met
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Additional Provisions
> For Class III or high risk product manufacturers, they can only
rely on equivalent products in limited circumstances such as
the same manufacturer of an already approved device.
> Clinical investigations may be required for devices in class I
and class IIa, and for class IIb devices that are not implantable.
> Non-EU-based manufacturing will have new scrutiny and
importers will be held liable for defects.
> The CE mark expires after 4 years for devices approved
before implementation of these provisions
> Importers and distributors will have to keep a register of
complaints, non-conforming products and recalls and
withdrawals.
References
> http://www.raps.org/RegulatoryFocus/News/2016/05/25/25017/Updated-EU-ReachesAgreement-on-New-Medical-Device-IVD-Regulations/
> http://www.europarl.europa.eu/RegData/etudes/BRIE/2016/58381
2/EPRS_BRI(2016)583812_EN.pdf
> http://www.emergogroup.com/blog/2016/06/theyre-here-newdraft-european-medical-device-ivd-regulations-published
> http://www.emergogroup.com/sites/default/files/europe-medicaldevice-regulation-consolidated-negotiated-text.pdf
> http://www.emergogroup.com/sites/default/files/europe-ivdregulation-consolidated-negotiated-text.pdf
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THANK YOU
Questions ?
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