market surveillance under the new regulation on medical devices … · electronic system on...
TRANSCRIPT
Market Surveillance Under the New Regulation on Medical Devices
A Regional Competent Authority´s Point of View
Niels Petersen
Authority for Health and Consumer Protection
Head of Unit Medical Devices
Billstr. 80
20539 Hamburg
Lübeck Summer Academy
September 14, 2016
Agenda
1. Medical Device Market – an Orientation
2. Market Surveillance in Germany Today
3. EUDAMED - A Key Instrument of the New Regulation on
Medical Devices
4. Market Surveillance Under the New Regulation on Medical
Devices
5. Conclusion / Questions
Medical Devices Market – an Orientation
Medical device market (excl. in vitro diagnostics)
Turnover world market: 220 billion €, thereof are
90 billion € for USA
76 billion € for Europe
28 billion € for Germany
Germany is the world's third largest single market after USA and
Japan
195,000 employees in Germany
(Source: BVMed Annual Report 2015)
Market Surveillance in Germany Today
Pillar A
Vigilance
system,
Risk evaluation
Pillar B
Distributors /
Operators and
Users
Pillar C
Manufacturer /
Authorised
Representa-
tives
Pillar D
Customs
procedure
(Release for
free
circulation)
Market surveillance of medical devices in Germany
Market Surveillance in Germany Today
Pillar A (Vigilance system / Risk evaluation):
focuses on devices where persons have been harmed
depends on the activity of the reporting persons
places high demands on the evaluating authority
Pillar B (Distributors / Operators and Users):
distributors are usually unknown
(no obligation to register, mobile traders)
findings by chance
no technical documentation available
Market Surveillance in Germany Today
Pillar C (Manufacturer / Authorised Representatives):
technical documentation available
inspection of the multiplier
Pillar D (Customs procedure / Release for free circulation)
depending on expertise of the customs
conflict of aims:
Time and effort of inspections vs. free circulation of goods
Market Surveillance in Germany Today
Flows of goods
Hamburg Airport
Air freight 2015: 52,000 tonnes
Port Hamburg
Total cargo handled 2015: 137.8 million tonnes
Container handled 2015: 8.9 million TEU
(Twenty-feet Equivalent Unit)
Market Surveillance in Germany Today
Market surveillance in Germany Today
Market surveillance in Germany Today
Market Surveillance in Germany Today
Key elements to improve health and safety under the new
Regulation on medical devices
Especially reinforcing the existing regulatory approach such as
supervision of notified bodies,
conformity assessment procedures,
clinical investigations and clinical evaluation,
vigilance and market surveillance
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Key elements to improve health and safety under the new
Regulation on medical devices
Introducing provisions ensuring transparency and traceability
regarding devices
Aligning rules applicable to medical devices with the New
Legislative Framework for the marketing of products
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
EUDAMED European database on medical devices
Electronic
system
on
registration
Medical devices / IVDs
economic operators,
incl.
Summary of safety
and clinical
performance
(high risk devices)
Electronic
system
on
UDI
Device Identifier
data elements
Electronic
system
on
notified bodies
and certificates
Certificates issued
by notified bodies
&
Information on
certificates
refused,
suspended,
reinstated,
restricted,
withdrawn
Electronic
system
on
vigilance and
on post-market
surveillance
Serious incidents
&
Field safety
corrective actions
&
Field safety notices
&
Periodic safety
update reports
Electronic
system
on
market
surveillance
Measures taken
by Member States re.
devices presenting a
risk to health & safety
&
preventive health
protection measures
Electronic
system
on
clinical
investigations
Sponsors
Description of:
investigational
device,
comparator,
purpose of CI,
status of CI
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Central database
Electronic system on registration and on notified bodies and
certificates
shall enable the public to be informed about
• devices on the Union market,
• relevant economic operators and
• certificates
Electronic system on UDI
shall allow the identification and facilitate
the traceability of devices
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Electronic system on clinical investigations
shall serve as tool for the cooperation between Member States
shall enable sponsors to submit a single application for several
Member States
shall enable reports of serious adverse events,
device deficiencies and related updates.
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Electronic system on vigilance and on post-market surveillance
shall enable manufacturers to report
• serious incidents and
• other reportable events
shall support the coordination of their assessment by competent
authorities of the Member States
Electronic system regarding market surveillance
shall serve as tool for the exchange
of information between competent authorities
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Electronic system on vigilance and post–market surveillance
Serious incidents and field safety corrective actions
Periodic safety update reports for devices in class III or implantable devices
summarising the results and conclusions of the analyses of the gathered post-market surveillance data together
• with a rationale and
• a description of any preventive and corrective actions taken
Notified body shall review the report and add its evaluation to the database with details of any action taken
Reports and the notified body evaluation shall be available to competent authorities
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Electronic system on vigilance and post–market surveillance
Periodic summary reports instead of individual serious incident reports
for
similar serious incidents with the same device or device type
and for which
• the root cause has been identified or
• a field safety corrective action is implemented or
• where the incidents are common and well documented
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Electronic system on vigilance and post–market surveillance
Trend reporting for a statistically significant increase of incidents
(not only serious incidents !) and /or of expected undesirable side-
effects
that could have a significant impact on the risk-benefit analysis
and
which have led or may lead to unacceptable risks to the health or
safety of patients, users or other persons when weighted against
the intended benefits
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Electronic system on vigilance and post–market surveillance
Competent authorities may conduct their own assessments on the trend
reports and require the manufacturer to adopt appropriate measures
Competent authorities shall inform
the Commission,
the other competent authorities and
the notified body that issued the certificate,
of the results of such evaluation and of the adoption of such measures
EUDAMED
A Key Instrument of the New Regulation on Medical Devices
Market surveillance carried out by authorities
Closer coordination between national competent authorities through
information exchange and coordinated assessments under the
direction of a coordinating authority
Joint working, coordination and communication of activities should
lead to more efficient use of resources and expertise at national
level
Market Surveillance Under the New
Regulation on Medical Devices
Market surveillance carried out by authorities
Competent authorities shall
draw up annual surveillance activities plans
allocate a sufficient number of competent human and material
resources
take into account the European market surveillance program
developed by the Medical Device Coordination Group and local
circumstances t
Market Surveillance Under the New
Regulation on Medical Devices
Market surveillance carried out by authorities
Competent authorities shall
carry out inspections of
• the premises of economic operators, suppliers
and/or subcontractors,
• facilities of professional users
draw up a report of the findings of the inspection
• the final inspection report shall be entered into the electronic
system
prepare an annual summary of the results of the surveillance
activities and make it accessible to other competent authorities
Market Surveillance Under the New
Regulation on Medical Devices
Market surveillance carried out by authorities
Competent authorities shall
perform appropriate checks on the conformity characteristics and
performance of devices including, where appropriate,
• review of documentation and
• physical or
• laboratory checks
on the basis of adequate samples
in particular, take account of established principles regarding risk
assessment and risk management, vigilance data and complaints
Market Surveillance Under the New
Regulation on Medical Devices
Sovereign powers of market surveillance authorities
Competent authorities may
require economic operators to
• make available documentation and information necessary
• provide necessary samples of devices or access to the device
free of charge
confiscate, destroy or otherwise render inoperable devices
• presenting an unacceptable risk or
• falsified devices
where deemed necessary
Market Surveillance Under the New
Regulation on Medical Devices
Medical Device Coordination Group (MDCG)
Task (inter alia):
to assist the competent authorities of the Member States in their
coordination activities in particular in the fields of …
• vigilance and market surveillance
• including the development and maintenance of a framework for
a European market surveillance program
with the objective of efficiency and harmonisation of market
surveillance in the European Union
Market Surveillance Under the New
Regulation on Medical Devices
MDCG
MDCG may invite experts and other third parties to attend meetings
or provide written contributions
MDCG may establish standing or temporary sub-groups
The Commission shall provide technical, scientific and logistic
support to the MDCG and its sub-groups
Expert panels and expert laboratories may provide scientific,
technical and clinical assistance to the MDCG in relation to the
implementation of this Regulation
Market surveillance under the new
Regulation on medical devices
Conclusion
The new regulation defines a framework to
reinforce the rights and obligations of the national competent
authorities,
ensure effective coordination of their market surveillance
activities and
clarify the applicable procedures,
to improve patient safety
But some questions arise for competent authorities, e.g. …
Conclusion / Questions
How is the “sufficient number of competent human and material
resources” to be determined?
How can a uniform level of qualification for inspectors be ensured
across all Member States?
How can an equivalent standard for inspections reached across all
Member States?
Conclusion / Questions
How can be avoided, when a coordinated authority is designated,
that all other competent authorities of the Member States perform
their own assessment and adopt measures?
How can a surveillance of distance sales effectively be performed?
What about inspections on premises of suppliers in third countries?
How can MDCG fulfill its tasks?
Conclusion / Questions
Thank you!
Do you have questions?