Talk 9 NAMSA EM

Transcription

Talk 9 NAMSA EM

EROMED
European Regulation of Medical
Devices Seminar
13 October 2014
ISO 9001:2008 Certified | NAMSA Medvance 2014 © | www.medvance.co.uk | www.medvanceresourcing.com
The Need for Clinical
Evidence Post CE Marking
Edith Millan
Principal Medical Research Manager
Agenda
• Collection of clinical evidence throughout
the products lifecycle
• Post market clinical follow-up
• How to collate and collect the data and the
key processes applicable
Product Life Cycle
Iterative device development
IDEA
DESIGN
FEEDBACK
MANUFACTURE
USE
End of product life
Destruction, disposal
When do we need clinical evidence?
During the
conformity
assessment process
Post Market
Surveillance
(repeat periodically)
WHAT IS POST MARKET SURVEILLANCE
(PMS) ?
What is PMS?
• PMS is the follow-up of device(s) post-CE marking
• PMS is a “safety net” to ensure continued safety and
effectiveness of marketed products
• PMS is following new devices into “the real world”
Definitions
• Post-market Surveillance (PMS) study– a broad
ranging term for any study of a CE marked device. This
may be to collect data on how a device performs
relative to a competitor product for marketing purposes,
or to collect additional data on the safety and
performance of a device for renewal of reimbursement.
Definitions (cont)
• Post-market Clinical Follow-up (PMCF) study - A
study carried out following the CE marking of a device
and intended to answer specific questions relating to
clinical safety or performance (i.e. residual risks) of a
device when used in accordance with its approved
labelling.
Post Market Surveillance (PMS) is always required. A
PMCF study is a specific PMS tool that can be applied if
warranted. In general, PCMF studies are an extension of
regulatory studies post CE marking.
Why Perform PMS?
Manufacturers must have an appropriate system for gaining and
reviewing use of a product once CE marked
•
Annex VII part 4 – MDD Conformity Assessment procedures states:
• “The manufacturer shall institute and keep up to date a systematic
procedure to review experience gained from devices in the postproduction phase and to implement appropriate means to apply any
necessary corrective action”
•
Annex X – Clinical evaluation of the revised MMD states:
• “The clinical evaluation and its documentation have to be actively
updated. Where post marketing clinical follow up as part of the post
market surveillance plan for the device is not deemed necessary, this
must be duly justified and documented.”
Why Perform PMS? (cont)
• Regulatory (pre-CE marking) clinical investigations
provide limited information
• Early warning system
• New approach of directives suggest a more proactive
approach
• Notified Bodies have to audit/verify that an effective
system is in place
What can PMS achieve?
•
•
•
•
•
•
•
•
Detection of manufacturing problems
Product quality improvement
Confirmation (or otherwise) of risk analysis
Knowledge of long-term performance/reliability
and/chronic complications
Knowledge of changing performance trends
Knowledge of performance in different user populations
Identification of vigilance reports
Knowledge of ways in which the device is misused
WHAT CAN PMS STUDIES ACHIEVE
Training needs
for
users
Continuing
market
viability
Instructions
for
use
Feedback
Indications
of use
Use with
other devices
Customer
satisfaction
Post Market Phase
METHODS OF OBTAINING PMS DATA
Expert
User
Group
Media
Regulatory
bodies
In house
testing
Customer
survey
PMS
Studies
Complaints
Warranty
claims
Literature
reviews
Sales
force
POST MARKET ACTIVITIES
Post Market Activities
• Proactive – Post Market Surveillance Studies
• Reactive – Vigilance
Requirements of PMS?
Risk
(based on intended use)
PMS requirements
Factors to Consider – PMS Requirements
• Whether or not the device is new to the manufacturer
• The extent of available scientific knowledge (e.g. on long term
performance)
• The state of the art and market experience with similar devices
• How can the manufacturer be more proactive?
When to conduct post CE mark Clinical
Studies?
• Continue regulatory clinical investigations (CE marking) into post
marketing phase to establish medium and long term safety and
performance
• Conduct PMS studies on devices for which there were no regulatory
clinical investigations prior to CE marking
Types of PMCF Studies
• the extended follow-up of patients enrolled in premarket
investigations
• a new clinical investigation
• a review of data derived from a device registry
• a review of relevant retrospective data from patients previously
exposed to the device
Types of PMCF Studies (cont)
•
•
•
•
•
•
RETROSPECTIVE SURVEY /STUDY
CASE CONTROL STUDY
OUTCOME STUDIES
CASE STUDY
REGISTRY
PUBLICATION STUDIES
RETROSPECTIVE SURVEY/STUDY
• Examine the outcomes of past patients treated in a variety of ways,
outcome occurred to subjects before study commenced
• Medical records of patients, looking backwards in time, at events
that happened in the past
• Unplanned, observational with serious potential biases
Past Data
CASE CONTROL STUDY
Always retrospective
1) Identify people with disease or outcome of interest (cases)
2) Identify control group without disease or outcome
3) Examine the relationship of an attribute (intervention, exposure or
risk factor) to the outcome of interest by comparing the frequency or
level of the attribute in the cases and controls
Past Data From Selected Subjects
COHORT STUDY
.
Observational
Defined group of people followed over time
Outcomes of subsets compared
Examine exposure or non exposure to a particular intervention
Or factor of interest
Concurrent cohort study – Prospective
Historical cohort study - Retrospective
OUTCOME STUDIES
Usually focus on clinical utility v disease or condition
treatment and usually relate to four specific questions
1) Does the treatment extend a patients life?
2) Does the treatment reduce complications of disease?
3) Does the treatment improve the patients functioning or
quality of life?
4) Is the treatment cost effective?
CASE STUDY
• One patient’s treatment and response reported as an
interesting occurrence
• Does not enable inferences to be made
• Anecdotal
REGISTRY
• Data on large numbers of patients receiving care in diverse clinical
settings
• Include clinical outcomes over time - provides a critical platform for
capturing the experience with a medical device throughout the
device and patient lifecycle.
• Used for long-term surveillance, fulfilment of postmarked
commitments for regulatory bodies, comparative effectiveness
assessments, and demonstration of effectiveness in under-studied
subpopulations
PUBLICATION STUDIES
• To conduct research about the device in order to obtain publications
and get publicity
• Marketing studies!
VIGILANCE
VIGILANCE
Manufacturers have an obligation to record safety performance of
their medical devices
Information on safety of medical devices can be obtained through:
• adverse events reported by Investigators in PMCF studies
• through manufacturers submitting vigilance reports to the
relevant competent authorities
Medical Device Vigilance System
• To improve the protection of health and safety of patients, users
and others by reducing the likelihood of reoccurrence of the
incidents
• Notification and evaluation of incidents and Field Safety
Corrective Actions (FSCA) involving medical devices
Incident – any malfunction or deterioration in the characteristics and/or
performance of a device, as well as inadequacy in labelling or IFU which,
directly or indirectly, might lead to or might have lead to the death of a
patient, or user or other person, or to a serious deterioration in their state
of health
FSCA – taken by the manufacturer to reduce risk of death or serious
deterioration in the state of health associated with the use of a medical
device already on the market
An adverse incident may arise due to:
Shortcomings in design
or manufacture
Inadequate servicing
and maintenance
Inadequate instructions
for use
Inappropriate
user practices
Locally initiated modifications
or adjustments
Selection of
incorrect device
Environment in which
Device is used or stored
Purpose and Principles of Vigilance
• Protection of health and safety of patients, users and
others
• Allow data to be correlated between CAs and
manufacturers
• Monitoring of experiences with devices
• Initial and final reports
• Manufacturers to keep Notified Body informed
Purpose and Principles of Vigilance
• Data is kept confidential
• Reporting an incident is not an admission of liability
• Incident due to two or more separate devices – each
manufacturer to submit
PMS versus Vigilance
PMS
VIGILANCE
Obligation to operate a system to obtain
feedback from the market
Reporting of serious incidents to CA
Collection, evaluation and response to
data on device performance after approval
Sharing of data on incidents with the CAs to
enable the need for corrective action to be
identified and carried out as early as
possible
Vigilance guidance for specific devices
•
•
•
•
•
•
•
•
•
Artificial heart valves
Breast implants
Cardiac ablation catheters
Coronary stents
Inferior vena cava filters
Intraocular lenses
IVD blood glucose meters used in POCT or in the home
Joint replacement implants
Neurostimulators
Typical events
•
•
•
•
•
A malfunction or deterioration in the characteristics or performance
Unanticipated adverse reaction or unanticipated side effect
Interactions with other substances or products
Degradation of the device
Inaccuracy in labelling, instructions for use. Inaccuracies include
omissions and deficiencies
Criteria for Incidents to be reported to CA
Any event which meets all three reporting criteria A-C
A. An event has occurred
B. The Manufacturer’s device is suspected to be a contributory cause
of the INCIDENT
C. The event led, or might have led to one of the following outcomes:
- death of a patient, user or other person
- serious deterioration in state of health of a patient, user or other
person
Criteria for Incidents to be reported to CA
Not all INCIDENTs lead to death or serious deterioration of health.
It is sufficient that:
• An INCIDENT associated with a device happened, and
• The incident was such that, if it occurred again, it might lead to
death or serious deterioration in health.
Conditions where reporting under the Medical
Device Vigilance System is not usually
required
Deficiency of a device
found by the user prior
to its use
Expected & foreseeable
side effects
Event caused by
patient’s conditions
Negligible likelihood of
occurrence of death
or serious deterioration
in state of health
Service life or shelf-life
of med device exceeded
Protection against a
fault functioned
correctly
Determining reportability
Questions
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
Was the device used?
Related to device?
Death or serious injury?
Could death or serious injury have occurred?
Were the clinical indications right?
Did the device perform as intended?
Did the device cause or contribute?
Is the event common and foreseeable?
Was the labelling followed?
Was device life exceeded?
Manufacturers role
Responsible for:
• notifying the relevant National Competent Authority about
incidents and field safety corrective actions when reporting
criteria are met (can be delegated to an authorised
representative) via an incident report.
• investigating the incidents and taking corrective action
• ensure relevant personnel are aware of the guidelines
• inform relevant personnel of incident reports
• keep Notified Body advised of issues occurring in the post
production phase affecting the certification
Timescale for initial reporting of an incident
•
•
•
Serious public health threat: IMMEDIATELY (without any delay that could
not be justified) but no later than 2 calendar days after awareness by the
Manufacturer of this threat.
Death or Unanticipated serious deterioration in state of health:
IMMEDIATELY (without any delay that could not be justified) after
Manufacturer established a link between the device and the event but no
later than 10 elapsed calendar days following the date of awareness of the
event.
Others: IMMEDIATELY (without any delay that could not be justified) after
Manufacturer established a link between the device and the event but no
later than 30 elapsed calendar days following the date of awareness of the
event.
Summary
• Clinical evidence is required post CE - performance and safety
• Process – Post Market Surveillance (PMS)
– Post Market Clinical Follow-up (PMCF)
– Vigilance
Reference Documents
•
•
MEDDEV 2.12-2 rev2 2012 Post market clinical follow-up studies a
guide for manufacturers and notified bodies
MEDDEV 2.12-1 rev8 2013 Guidelines on a medical devices vigilance
system

Talk 9 NAMSA EM

Transcription

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