Market Surveillance Under the New Regulation on Medical Devices … · Electronic system on...

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


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


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


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

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


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


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


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


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


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


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



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



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



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


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


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





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





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



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



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



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


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?


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?


Thank you!

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