上市后臨床跟蹤管理程序

1. PURPOSEThe

purpose

of

this

work

instruction

is

to

define

the

process

to

determine

anddocument

whether

a

post-market

clinical

follow-up

study

is

required

forTDIFoot/Ankle

Array

8ch

medical

devices

bearing

the

CE

mark. The

process

will

leadto

a

determination

of

whether

a

post-market

clinical

follow-up

study

is

required

andprovide

guidance

for

post-market

clinical

monitoring

requirements

if

a

study

is

notrequired.2. SCOPEThe

work

instruction

applies

to

all

medical

device

businesses

and

sites

operatingunder

the

TDI

Foot/Ankle

Array

8ch

Healthcare

Quality

Management

System.Only

medical

devices

bearing

the

CE

Mark

will

be

required

to

follow

this

workinstruction.3. REFERENCES3.1. External

References3.1.1. Laws Council

Directive

93/42/EEC

of

14

June

1993

concerning

medical

devicesincluding

amendments

through

05

September

20073.1.2. Guidance

Documents European

Commission

Enterprise-Directorate-General

MEDDEV

2.12-2Guidelines

on

Post

Market

Clinical

Follow-Up

dated

May

2004 MEDDEV

2.7.1

Rev.3

guidelines

on

medical

device-clinical

evaluation-a

guide

formanufacturers

and

notified

bodies

dated

April

2009 GHTF

Post-Market

Clinical

Follow-Up

Studies;

SG5(PD)N4R7

(Proposeddocument

23

July

2008) GHTF

Clinical

Investigations;

SG5(PD)N3R7

(20

January

2008)4. ROLES

AND

RESPONSIBILITIESImportant:When

a

title

of

a

position

is

listed

in

this

work

instruction,

it

relates

tothat

position

or

its

equivalent.Below

are

the

roles

and

responsibilities

discussed

within

this

document.

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???

?

???????

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??????

?

? 5. WORK

INSTRUCTIONPost-market

clinical

monitoring

is

an

essential

element

in

establishing

long

termsafety

follow-up

data

and

possible

emergent

risks

for

medical

devices. These

risksand

data

cannot

adequately

be

detected

and

characterized

by

relying

solely

onpre-market

clinical

investigations.Post

market

clinical

monitoring

may

include

a

combination

of

several

strategies:

Product

complaint

review

Post-market

event

reporting

review

of

users

and

patients

Literature

review

Post-market

clinical

follow-up

studies

(PMCFS)This

work

instruction

was

created

to

determine

when

a

PMCFS

is

necessary

tomaintain

an

adequate

post-market

surveillance

system,

as

required

by

the

MedicalDevice

Directive

93/42/ECC

(MDD)

as

amended

by

MDD

2007/47/EC. It

will

alsoprovide

guidance

on

the

post-market

clinical

monitoring

requirements

if

a

PMCFS

isnot

required.Figure

5-1:

High-Level

Process

Overview

for

Post-Market

Clinical

Follow-Up

PMCFS

Risk

PMCFSPMCFSYES

PMCFS

GEHC_GQP_10.03

GEHC_GQP_10.03.002,

a

,

AE抯

a

PMCFS

5.1. General

Requirements5.1.1. Prior

to

M3

sign-off,

the

Product

Regulatory

Affairs

Representative

in

consultationwith

the

Research

Manager

or

designee

and

the

Design

Engineering

and/orEngineering

Representative

shall

determine

for

a

given

project/program

whether

aPMCFS

is

required. They

shall

also

determine

the

post-market

clinical

follow-upplan.5.1.2. A

PMCFS

may

not

be

required

for

products

for

which

medium/long-term

clinicalperformance

and

safety

is

already

known

from

previous

use

of

the

device

or

whereother

appropriate

post-market

surveillance

activities

would

provide

sufficient

datato

address

the

risks.5.2. Determining

the

Type

of

Post-Market

Clinical

Follow-UpRequiredPost-market

clinical

monitoring

shall

have

one

of

two

outcomes,

(1)

PMCFS

requiredor

(2)

no

PMCFS

required.The

need

for

a

PMCFS

shall

be

based

on

a

combination

of

several

factors

detailed

inthis

section.5.2.1. The

Product

Regulatory

Affairs

Representative

in

consultation

with

the

ResearchManager

or

designee

and

Design

Engineering

and/or

Engineering

Representativeshall

determine

whether

an

equivalent

device

exists. Equivalence

shall

bedemonstrated

in

all

the

essential

characteristics

precisely

defined

below.Equivalence

means: Clinical Used

for

the

same

clinical

condition

or

purpose; Used

at

the

same

site

in

the

body; Used

in

similar

population

(including

age,

anatomy,

physiology); Have

similar

relevant

critical

performance

according

to

expected

clinicaleffect

for

specific

intended

use Technical Used

under

similar

conditions

of

use; Have

similar

specifications

and

properties; Be

of

similar

design; Use

similar

deployment

methods Have

similar

principles

of

operation Biological Same

or

similar

use

of

materials

in

contact

with

human

tissues

or

bodyfluids5.2.2. Products

for

which

the

medium/long

term

clinical

performance

and

safety

is

alreadyknown

from

previous

use

of

the

device,

or

from

fully

transferable

experience

withequivalent

devices

shall

not

require

a

PMCFS.NOTE:If

the

device

quoted

as

the

“equivalent”

requires

a

PMCFS,

then

the

newproduct

shall

be

subject

to

the

same

requirement.5.2.3. The

need

for

a

PMCFS

shall

be

determined

based

on

the

identification

of

residualrisks

that

may

impact

the

risk/benefit

ratio. A

study

should

always

be

consideredfor

devices

where

the

identification

of

possible

emerging

risks

and

the

evaluation

oflong

term

safety

and

performance

are

essential. The

Product

Regulatory

AffairsRepresentative

in

consultation

with

the

Research

Manager

or

designee

and

DesignEngineering

and/or

Engineering

Representative

shall

identify

such

emerging

risk,

thefollowing

criteria

should

be

taken

into

account: innovation,

e.g.,

where

the

design

of

the

device,

the

materials,

the

principlesof

operation,

the

technology

or

the

medical

indications

are

novel; high

risk

anatomical

locations

(i.e.,

heart,

central

nervous

system,

etc.); severity

of

disease/treatment

challenges; sensitivity

of

target

population

(i.e.,

infants,

children,

pregnant

women,etc.); identification

of

an

acceptable

risk

during

the

pre-CE

clinical

evaluation,which

should

be

monitored

in

a

longer

term

and/or

through

a

largerpopulation; well

known

risks

identified

from

the

literature

or

similar

marketed

devices; discrepancy

between

the

pre-market

follow-up

time

scales

and

the

expectedlife

of

the

product;5.2.4. A

properly

conducted

risk

analysis

is

essential

in

determining

what

clinical

evidencemay

be

needed

for

a

particular

device. Any

risks

identified

as

an

“unacceptable”risk

at

the

conclusion

of

the

development

process

shall

require

a

PMCFS.

A

studyshould

also

be

considered

for

risks

identified

as

“acceptable”

or

“risk

mitigationrequired”

if

the

meets

any

of

the

other

characteristics

identified

in

5.2.1

and5.2.2. The

risk

assessment

shall

be

performed

according

to

the

Risk

ManagementProcedure.

The

Product

Regulatory

Affairs

Representative

shall

review

the

riskassessment.5.2.5. The

Product

Regulatory

Affairs

Representative

shall

complete

the

Post

MarketClinical

Follow-Up

Study

Determination

Form

(Appendix

A)

once

the

decisionregarding

the

need

for

a

study

has

been

determined. 5.2.6. The

Product

Regulatory

Affairs

Representative

shall

complete

the

Post-MarketClinical

Follow-Up

Plan

(Appendix

B)

that

details

the

plan

for

post-market

clinicalfollow-up.5.2.7. The

Research

Manager

or

designee

and

Medical

Affairs

Representative

shall

reviewthe

Post-Market

Clinical

Follow-Up

Justification

Form

and

The

Post-Market

ClinicalFollow-Up

Plan

to

confirm

the

decisions

regarding

post-market

clinical

monitoring.5.3. No

Post

Market

Clinical

Follow-Up

Study

Required5.3.1. If

it

was

determined

that

no

PMCFS

is

required

(based

on

section

5.2),

post-marketclinical

monitoring

is

still

required

for

the

medical

device.5.3.2. Justification

regarding

the

decision

not

to

perform

a

PMCFS

must

be

clearlydocumented

and

maintained

in

the

design

history/technical

file

(see

5.2.5).5.3.3. Post-Market

Clinical

Monitoring

Requirements

(minimum).

At

a

minimum,

the

following

post-market

clinical

monitoring

activities

shall

becompleted

according

to

TDI

Foot/Ankle

Array

8ch

established

procedures/workinstructions. These

elements

will

be

inputs

into

the

Post-Market

LiteratureEvaluation

and

Market

Analysis

Report. Review

of

product

complaints

according

to

Complaint

Handling

Procedure Review

of

post

market

adverse

events

according

to

Post

Market

EventReporting

Procedure Literature

review

according

to

TDI

Foot/Ankle

Array

8ch

Evaluation

ofClinical

Data

to

Support

CE

Marking

Work

Instruction

..

Review

of

product

complaints,

post

market

adverse

events

and

the

literature

reviewshall

be

completed

at

the

intervals

specified

in

Table

5-1. The

timing

outlinedprovides

the

minimum

requirements. The

Product

Regulatory

AffairsRepresentative

and/or

the

Research

Manager

or

designee

can

determine

thatclinical

data

shall

be

reviewed

more

often.Table

5-1:

Timing

for

Review

of

Clinical

Data

based

on

Medical

Device

ClassDevice

ClassificationClass

Class

IIa,

IIbClass

Timing

for

review

of

clinical

data

(minimum)AnnuallyAt

a

minimum

annually,

should

consider

more

oftenSemi-annually

(i.e.

twice

a

year),

should

considermore

often.

At

the

interval

outlined

in

Table

5-1,

the

Research

Manager

or

designee

shallcomplete

a

literature

review

and

analysis

of

post-market

experiences

(plaints

and

adverse

events)

and

re-evaluate

if

a

PMCFS

needs

to

be

conductedbased

on

this

data. The

Post

Market

Literature

Evaluation

and

Market

AnalysisConclusion

form

(Appendix

D)

shall

be

completed

and

maintained

as

part

of

thedevice’s

design

history/technical

file. The

Product

Regulatory

AffairsRepresentative

and

Medical

Affairs

Representative

shall

review

and

approve

thisdocument. 5.4. Post

Market

Clinical

Follow-Up

Study

Required5.4.1. If

it

was

determined

that

a

PMCFS

is

required,

in

addition

to

the

requirements

listedunder

5.3.3,

studies

such

as

extended

follow-up

of

patients

enrolled

in

thepre-market

trials,

prospective

study

of

a

representative

subset

of

patients

after

thedevice

is

placed

on

the

market,

or

an

open

registry

may

be

performed.5.4.2. The

PMCFS

shall

be

carried

out

in

accordance

with

TDI

Foot/Ankle

Array

Research

Involving

Human

Subjects

Procedure5.4.3. The

Research

Manager

or

designee

in

consultation

with

the

Regulatory

AffairsRepresentative

and

the

Design

Engineering

and/or

Engineering

Representative

willdetermine

the

type

of

PMCFS

that

will

be

implemented.5.4.4. The

study

should

take

into

account

the

following: Results

of

the

clinical

investigation

including

adverse

events

identified Average

life

expectancy

of

the

device The

claims

made

by

the

manufacturer

for

the

device Performances

for

which

equivalence

is

claimed New

information

becoming

available.

At

the

interval

outlined

in

Table

5-1,

the

Research

Manager

or

designee

shallcomplete

a

literature

review

and

analysis

of

post-market

experiences (plaints

and

adverse

events)

and

review

the

ongoing

results/data

of

the

PMCFS.The

Post

Market

Literature

Evaluation

and

Market

Analysis

Conclusion

form(Appendix

D)

shall

be

maintained

as

part

of

the

device’s

design

history/technical

file.The

Product

Regulatory

Affairs

Representative

and

Medical

Affairs

Representativeshall

review

and

approve

this

document. 5.5. Elements

of

a

post-market

clinical

follow-up

study5.5.1. Post-market

clinical

follow-up

studies

are

performed

on

a

device

within

its

intendeduse/purpose(s)

according

to

the

instructions

for

use.5.5.2. A

PMCFS

shall

include

the

elements

defined

in

the

Writing

Clinical

InvestigationalPlans

and

Protocols

Work

Instruction.5.5.3. The

objective(s)

of

a

PMCFS

should

be

stated

clearly

and

should

address

the

residualrisk(s)

identified. It

should

be

formulated

to

address

one

or

more

specificquestions

relating

to

the

clinical

safety

or

performance

of

the

device.5.5.4. Post-market

clinical

follow-up

studies

should

be

designed

to

address

the

objective(s)of

the

study. The

design

may

vary

based

on

the

objective(s)

and

should

bescientifically

sound

to

allow

for

valid

conclusions

to

be

drawn.5.5.5. The

study

design

can

take

several

forms,

for

example:

the

extended

follow-up

of

patients

enrolled

in

pre-market

investigations;

a

new

clinical

investigation;

a

review

of

data

derived

from

a

device

registry;

a

review

of

relevant

retrospective

data

from

patients

previously

exposed

tothe

device.

the

analysis

plan

including

any

interim

reporting;

and

procedures

for

early

study

termination.5.5.6. The

data

and

conclusions

derived

from

the

PMCFS

are

used

to

provide

clinicalevidence

to

support

the

post-market

surveillance

program. This

process

may

resultin

the

need

to

reassess

whether

the

device

continues

to

comply

with

the

EssentialPrinciples. Such

assessments

may

result

in

corrective

or

preventive

actions.6. APPENDIX6.1. Appendix

A:

Post-Market

Clinical

Follow-Up

Study

DeterminationXXXXXXX

<Name

XXXXXXX

need

be

1:

must

be

meet

XXXXXXX

XXXXXXX