Inspection of: Clinical trials, CAB, hospitals (reporting system, reprocessing and maintenance), companies («for cause» and providing support to foreign authorities)

RISK CLASS IIIe.g. hip implants,

heart valve

AIMDe.g. artificial heart,

pacemaker

Review of safety and performance by manufacturer

Additional procedures for:· Medicinal product constituents· Material of animal origin

Additional procedures for:· Medicinal product constituents· Material of animal origin

Certification by CAB

Certification by CAB

RISK CLASS IIbe.g. intraocular

lenses, insulin pumpsCertification by CAB

Certification by CABRISK CLASS IIa

e.g. surgical gloves, ultrasonic devices

RISK CLASS Is / Ime.g. sterile plasters,

patient scales

RISK CLASS Ie.g. wheelchair

IVDe.g. pregnancy test,

HIV test

Certification by CAB

Certification / partly batch release by CAB

The manufacturer is responsible for verifying safety and performance

Evaluation of safety and performance by the manufacturer

Prod

uct /

Tech

nolo

gy

Asse

ssm

ent o

f tec

hnic

al fe

asib

ility

Med

ical

indi

catio

n (in

tend

ed u

se),

if ap

plic

. Dev

elop

men

t of a

pro

toty

pe p

lus

inst

ruct

ions

for u

se

Impl

emen

t qua

lity

man

agem

ent s

yste

m /

qual

ity a

ssur

ance

prin

cipl

es

Prec

linic

al te

sts,

acco

rdin

g to

test

sta

ndar

ds if

pos

sibl

e

Clin

ical

tria

ls if

nec

essa

ry (a

ppro

ved

by S

wis

smed

ic a

nd c

anto

nal e

thic

s co

mm

ittee

)

Eval

uate

clin

ical

dat

a, c

ompl

ete

clin

ical

eva

luat

ion

repo

rt a

nd in

stru

ctio

ns fo

r use

, ev

alua

te c

ompl

ianc

e w

ith e

ssen

tial r

equi

rem

ents

Lite

ratu

re re

view

, eva

luat

ion

of b

ioco

mpa

tibili

ty, r

isk

anal

ysis,

risk

eva

luat

ion,

risk

-ben

efit

asse

ssm

ent.

Ri

sk re

duct

ion

mea

sure

s

Decl

arat

ion

of C

onfo

rmity

Med

ical

dev

ices

acc

ordi

ng t

o gr

oups

and

ris

k cl

asse

s

Prod

uctio

n (p

rodu

ctio

n si

te a

udits

/ de

vice

test

ing)

Prov

ide

inst

ruct

ion

and

furt

her t

rain

ing

for u

sers

if a

pplic

. / tr

aini

ng (m

edic

al a

nd h

ospi

tal s

taff,

nur

sing

sta

ff)

Post

-mar

ket s

urve

illan

ce (P

MS)

and

pos

t-m

arke

t clin

ical

follo

w-u

p (P

MCF

) by

lega

l man

ufac

ture

r

· Obl

igat

ion

to re

port

inci

dent

s an

d co

rrec

tive

actio

ns to

Sw

issm

edic

· P

ublic

atio

n of

saf

ety-

rela

ted

actio

ns b

y Sw

issm

edic

Recertification by CAB

Recertification by CAB

Recertification by CAB

Recertification by CAB

CAB audits manufacturer

CAB audits manufacturer

CAB audits manufacturer

CAB audits manufacturer

Mar

ket s

urve

illan

ce b

y Sw

issm

edic

SAFETY Technical evidence. PERFORMANCE / EFFICACY Clinical evaluations

Registration according to MedDO Art. 6 Exemptions Export certificates

PHASE 2: MARKET LAUNCH

PHASE 3: POST-MARKET SURVEILLANCE (after market launch)

PHASE 1: DEVELOPMENT UP TO MARKET CONFORMITY pre-market

The tasks of Swissmedic – Lifecycle of a medical device

CLA

SS II

IA

IMD

CLA

SS II

bCL

ASS

IIa

IVD

CLA

SS I,

Is, I

m

1

43

6

7

52 2

2

2

2

2

2

2

2 2

2

2

2

2

2

2

2

2

2

2

1

Approve clinical trials

2

Designation and surveillance of the Conformity Assessment Bodies1 (CAB)

6

Market surveillance (MKM)

7

Inspections

3

· Mandatory notification for placing on the market (notifications according to MedDO Art. 6)· Exemptions

5

Materiovigilance (MV)

4

Export certificates (FSC)

/ CAB audits manufacturer

CAB audits manufacturer

Recertification by CAB

Recertification by CAB

Review of safety and performance by manufacturer

1 Notified Body (NB) in the context of the EU internal market