dr. adelheid schneider, roche diagnostics gmbh · 2015-11-02 · dr. adelheid schneider, roche...
TRANSCRIPT
Regulation of Medical Devices –
International Industry perspective
Dr. Adelheid Schneider, Roche Diagnostics GmbH
Some words about the Roche Group
Challenges to register medical devices worldwide
Points to consider when setting up regulations
Recommendations regarding the regulatory framework
Roche: Basic facts at a glance
• Founded 1896 in Basel, Switzerland
• Founding families still hold majority stake
• Employing 88,500 people
• Currently active in 150 countries on all continents
• Clear focus on healthcare
• Leadership in pharmaceuticals (#3)*
• World’s largest biotech company (position #1)* with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS
• Leadership in in vitro diagnostics (#1) and pioneer in diabetes management
* Source: Decision Resources, Q4/2014
Ph
arm
aD
iag
no
sti
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Roche Group Our Structure
Chugai
Genentech
Roche Pharma
Diabetes Care
Tissue Diagnostics
Molecular Diagnostics
Professional Diagnostics
Professional
DiagnosticsBusiness Area
Molecular
DiagnosticsBusiness Area
Tissue
DiagnosticsBusiness Area
Diabetes Care
Business Unit
• Serum work area/immuno-
assays and clinical
chemistry
• Point-of-care testing
• Coagulation and specialty
testing
• Workflow management
• Custom Biotech
• Virology
• Blood screening
• Genomics/oncology
• Microbiology
• Women’s health
• Biochemical reagents
• Nucleic acid DNA purifi-
cation and real-time PCR
• Primary staining
• Advanced staining
• Workflow management
• Digital pathology
• Blood glucose monitoring
• Insulin delivery
• Diabetes management
systems
Sequencing Unitoffering sequencing solutions for both
clinical and life science segments
Roche Diagnostics DivisionServing both clinical and life sciences segments
ASEAN Association of
Southeast Asian Nations
The Latin American Alliance for the
Development of In Vitro Diagnostics
PAN AFRICAN HARMONISATION PARTY
Roche is in close interaction with
Some words about the Roche Group
Challenges to register medical devices worldwide
Points to consider when setting up regulations
Recommendations regarding the regulatory framework
1. Various forms of regulation exist to meet different needs
of individual countries.
2. No standardized wording in regulations and guideline
3. Individual Submission dossiers required by each
country
4. Additional requirements such as local testing or special
testing according local standards in some countries
required
Global Registration What are our challenges? (1)
Global Registration What are our challenges? (2)
5. High cost and expertise required to meet different
requirements of regulation systems
6. Long timelines to register products in countries
(sometime up to 3 years)
7. Lengthy and burdensome change approval and Re-
registration processes
8. Inspections from all over the world, different
approach regarding GMP
Some words about the Roche Group
Challenges to register medical devices worldwide
Points to consider when setting up regulations
Recommendations regarding the regulatory framework
To protect public health
and safety by ensuring
safety, quality, and
effectiveness
Fast access to affordable
medical devices
Goal
What have to be considered when setting up
regulations?AHWP PlaybookA Medical Device Regulatory Framework (2014)
Source: Playbook for Implementation of a Medical Device Regulatory Framework , Asian Harmonization Working Party ,Technical Committee (TC)
A guide to countries with no framework
or existing framework.
What have to be considered when setting up
regulations?Summary
Ensure an appropriate balance between pre-
market and post-market elements
Consider the implementation of more advanced
pre-market controls only when you have a base of
registration of your IVD medical device and
sufficient resources
Simplify / standardize the regulatory framework
premarket submissions or approval to market
Some words about the Roche Group
Challenges to register medical devices worldwide
Points to consider when setting up regulations
Recommendations regarding the regulatory framework
Regulatory Framework Follow the GHTF Regulatory Model
15
What is a medical device
What is needed to ensureSafety and performance
How to meet the EssentialPrinciples
What level of Conformity Assessment is appropriate
Supporting Documentation Submission file
What is needed to ensureThe safety of the product
Safe medicaldevice is placedon the market
Definition of medical device and IVD medical device
Essential Principles of Safety & Performance
Use of Standards (or other means)
Guidance on Clinical Evidence
Labeling (including Instructions for use)
Risk based classification Rules – Class A, B, C or D
Summary Technical File (STED)
Audit procedures and protocols
SG 4Post Market Vigilance and
Reporting Procedures
SG 2
SG 5
•Quality System•Design Control Process•Full Technical Evidence
SG 3
Provided by Benny Ohns, PAHWP – Capetown November 29-30, 2014
Regulatory Framework
Pharmaceuticals
Drug
Medical Devices
In vivo use
Active implantableMD
Medical Device
In vitro use
IVDs
Develop separate regulations for Pharmaceuticals,
MDs and IVDs or have different sections addressing
them
Are these all the
same?
Can they have one
regulatory
approach/framework?
Regulatory Framework Consider IVDs are different from Medical Devices
1. IVDs do not treat patients, they are non-invasive tests used on
biological samples (e.g. blood, urine, tissue, etc.)
2. IVDs never come into contact with patients. IVDs always
interact exclusively with samples taken from the patient to
obtain information of relevance.
3. The risks posed by IVDs to patients are based on the
information they provide. The risks to patients are therefore
indirect.
Source EDMA
IVD
Medical Device Active Implantable
Medical Device
Regulatory Framework What is needed to ensure safety and performance?
A manufacturer of a medical device is expected to design
and manufacture a product that is safe and performs as
intended.
’Essential Principles of Safety and Performance’
documented in the so called EP Checklist describes
fundamental design and manufacturing requirements to
ensure safety and effectiveness of the medical
device/IVD.
Regulatory Framework Standards
• Encourage the use of international standards.
• Establish a mechanism for recognizing
international standards to provide
manufacturers with a method of
demonstrating conformity with the Essential
Principles.
• Accept if conformity with the Essential
Principles can be demonstrated by another
means.
Regulatory Framework Clinical Evidence
Accept the global clinical study as
performance characteristics of an IVD
are not influenced by local conditions.
Ask for Local testing only in those rare
cases where there are significant local
conditions that are highly probable of
having influence on the performance.
Keep in mind that clinical evidence for
IVDs is totally different than for Medical
Devices.
Regulatory Framework Risk based classification rules
Establish
classificatio
n and
enhance
conformity
assessment
as
appropriate
Regulatory Framework Conformity Assessment Ensure that the requirements are set according to the risk class and
that lower risk products have accordingly lower requirements.
Class D
Class C
Class B
Class A
Approved QM System
Submission of comprehensive Technical Dossier required
Assessment of clinical performance
Approved QM System
Submission of comprehensive Technical Dossier required
Approved QM System
Submission of basicTechnical Dossier
required
Listing or
notification
only
HIV,
HCV, HBV,
HTLV, ABO,
Rhesus, Kell, and
Duffy System
.PSA, Down Syndrome,
Chlamydia, CMV, Rubella, Huntington, Troponin,
Prothrombin, Monitoring of HIV, Hepatitis B and C, HIV and HCV
genotoyping , Self testing devices an blood gases and
blood glucose determinations
B12, urine test strips, pregnancy self-test
Products not included in Class A, C, D
Controls without a quantitative or qualitative assigned value
Reagents for specific examination.
Instruments for IVD procedures
Specimen receptacles.
e.g., microbiological media, wash solutions, urine cups, culture media
IVD Classification Examples
Conformity assessment procedure
IMDRF, AHWP and WHO issued documents to give
guidance when submitting device information to
authorities
Sect. CSDT
Heading
3.0 Executive Summary
4.1 Essential Principles
4.2 Device Description
4.3 Design Verification and
Validation
4.4 Risk Management
4.5 Labelling
4.6 Manufacturer’s
Information
Agree on a common submission Dossier based on the GHTF
STED document, AHWP CSDT or WHO prequalification dossier
Further recommendationsAbridged registration processes
Acceptance of already available licenses for Roche
devices
Documented Evidence:
Free Sales certificate + ISO certificate of the manufacturer
This is a proof that the device is safe and
effective and fulfills the requirements to
market the device on the European
market including EFTA Member states like
Switzerland (CE-Mark)
Further recommendationsPost market processes Post-market surveillance and adverse events reporting
Establish a national coordinating agency to receive and
manage reports on issues related to medical devices.
Involve manufacturers in investigations of incidents and
resolution of issues before notifying other national competent
authorities.
Changes
Simplify Change Registration Process
This could help to prevent countries from having ready access
to new technologies and even may prevent implementation of
safety relevant changes.
Further recommendationsNomenclature System: What is GMDN?
Global Medical Device Nomenclature (GMDN)
The international standard (ISO 15225) for naming Medical
Devices
Used by 65 national Medical Device Regulators, backed by
IMDRF
Translated into 25 languages
Controlled distribution and updating
International acceptance
Work with one Nomenclature System (GMDN code) for
effective market surveillance, safety management and risk
management.provided by Mark Wasmuth – CEO, GMDN
Agency
Further recommendationsRequirements on Quality Management System
Accept ISO 13485 certificate
for establishment license and
Quality Management System
requirements
Accept IMDRF Single Audit
Program
Thanks for your attention
Thank you to Thomas Mall and Peter Martin for giving input to the presentation.
Disclaimer:
This presentation reflects the Roche position.
All errors in this presentation go on the account of the presenter.
This presentation is our intellectual property. Without our written consent, it shall neither be copied in any manner, nor communicated to third parties.
CV
Education and training
• 1986 - University Diploma – Food Technology Engineer, Hohenheim
• 1996 - Doctor of Science, Sc.D – Hohenheim
Working experience
• 1987-1991 Boehringer Mannheim: Technical Assistant Research and
Development in Protein Chemistry and Enzymology
• 1991-1995 FhG Stuttgart: Assistant Immunology and Cell biology
• Since 1995 Roche Diagnostics GmbH: various positions in Quality Control, Quality
Assurance, Documentation and Regulatory Affairs
Current position
Head of International Registration responsible for Regulatory Affairs for Roche within
the Diagnostic Business Area Roche Professional Diagnostics and
EMEA Reg. Affairs Regional Head for Roche Diagnostics responsible for regulatory
intelligence and advocacy Roche positions externally for Roche Diagnostics
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