Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Date: 1998-10-27
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, artificial reproduction, medical device, medical diagnosis, public health, single market

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I

(Acts  whose  publication  is  obligatory)

DIRECTIVE  98/79/EC  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL

of  27  October  1998

on  in  vitro  diagnostic  medical  devices

THE  EUROPEAN  PARLIAMENT  AND  THE  COUNCIL  OF
THE  EUROPEAN  UNION,

trade,  and  whereas 
to  establish
harmonised  rules  has  been  confirmed  by  a
comparative  survey  of  national  legislations  carried
out  on  behalf  of  the  Commission;

the  need 

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Article  100a  thereof,

Having  regard  to  the  proposal  from  the  Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting  in  accordance  with  the  procedure  laid  down  in
Article  189b  of  the  Treaty (3),

(1)  Whereas  measures  should  be  adopted  for  the
smooth  operation  of  the  internal  market;  whereas
the  internal  market  is  an  area  without  internal
frontiers  in  which  the  free  movement  of  goods,
persons,  services  and  capital  is  ensured;

(2)  Whereas  the  content  and  scope  of  the  laws,
regulations  and  administrative  provisions  in  force
in  the  Member  States  with  regard  to  the  safety,
health  protection  and  performance,  characteristics
and  authorisation  procedures 
in  vitro
diagnostic  medical  devices  are  different;  whereas
the  existence  of  such  disparities  creates  barriers  to

for 

(1)  OJ  C  172,  7.7.1995,  p.  21  and  OJ  C  87,  18.3.1997,  p.  9.
(2)  OJ  C  18,  22.1.1996,  p.  12.
(3)  Opinion  of  the  European  Parliament  of  12  March  1996  (OJ
C  96,  1.4.1996,  p.  31),  Council  common  position  of  23
March 1998 (OJ C 178, 10.6.1998, p. 7) and Decision of the
European Parliament of 18 June 1998 (OJ C 210, 6.7.1998).
Council  Decision  of  5  October  1998.

(3)  Whereas  the  harmonisation  of  national  legislation
is the only means of removing such barriers to free
trade  and  of  preventing  new  barriers  from  arising;
whereas  this  objective  cannot  be  achieved  in  a
satisfactory  manner  by  other  means  by 
the
individual  Member  States;  whereas  this  Directive
lays down only such requirements as are necessary
and  sufficient  to  ensure,  under  the  best  safety
conditions, 
in  vitro
free  movement  of 
diagnostic  medical  devices  to  which  it  applies;

the 

(4)  Whereas 

the  harmonised  provisions  must  be
distinguished 
the
from  measures  adopted  by 
Member  States  to  manage  the  funding  of  public
health  and  sickness  insurance  schemes  relating
directly  or  indirectly  to  such  devices;  whereas,
therefore,  the  harmonised  provisions  do  not  affect
the ability of the Member States to implement such
comply  with
that 
measures  provided 
Community  law;

they 

(5)  Whereas in vitro diagnostic medical devices should
provide  patients,  users  and  third  parties  with  a
high  level  of  health  protection  and  attain  the
performance levels originally attributed to them by
the  manufacturer;  whereas,  therefore,  maintenance
or  improvement  of  the  level  of  health  protection
attained  in  the  Member  States  is  one  of  the  main
objectives  of  this  Directive;

(6)  Whereas,  in  accordance  with  the  principles  set  out
in the Council resolution of 7 May 1985 on a new
and
approach 

harmonisation 

technical 

to 

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the 

rules 

regarding 

standards (1), 
design,
manufacture  and  packaging  of  relevant  products
must  be  confined  to  the  provisions  required  to
meet  the  essential  requirements;  whereas,  because
they are essential, such requirements should replace
the corresponding national provisions; whereas the
essential  requirements,  including  requirements  to
minimise  and  reduce  risks,  should  be  applied  with
discretion,  taking  into  account  the  technology  and
practice  at  the  time  of  design  and  technical  and
economic  considerations  compatible  with  a  high
level  of  protection  of  health  and  safety;

(7)  Whereas  the  major  part  of  medical  devices  are
covered  by  Council  Directive  90/385/EEC  of  20
June  1990  on  the  approximation  of  laws  relating
implantable  medical  devices (2)  and
to  active 
Council  Directive  93/42/EEC  of  14  June  1993
concerning  medical  devices (3)  with  the  exclusion
of in vitro diagnostic medical devices; whereas this
Directive  seeks  to  extend  the  harmonisation  to  in
vitro  diagnostic  medical  devices  and  whereas,  in
the  interest  of  uniform  Community  rules,  this
Directive  is  based  largely  on  the  provisions  of  the
said  two  Directives;

(8)  Whereas 

apparatus, 

instruments, 

appliances,
materials  or  other  articles,  including  software,
which  are 
intended  to  be  used  for  research
purposes,  without  any  medical  objective,  are  not
regarded  as  devices  for  performance  evaluation;

(9)  Whereas, 

although 

internationally 

certified
reference  materials  and  materials  used  for  external
quality assessment schemes are not covered by this
Directive,  calibrators  and  control  materials  needed
by  the  user  to  establish  or  verify  performances  of
devices  are  in  vitro  diagnostic  medical  devices;

(10)  Whereas,  having  regard 

the  principle  of
subsidiarity,  reagents  which  are  produced  within
in  that
health-institution 

laboratories  for  use 

to 

environment 
to
are 
commercialtransactions  are  not  covered  by  this
Directive;

subject 

and 

not 

(11)  Whereas,  however,  devices  that  are  manufactured
and  intended  to  be  used  in  a  professional  and
commercial  context 
for  purposes  of  medical
analysis without being marketed are subject to this
Directive;

(12)  Whereas  mechanical 

for 

laboratory 

falls  within 

the  scope  of 

equipment
in  vitro  diagnostic
especially  designed 
examinations 
this
Directive  and  whereas,  therefore,  in  order  to
relevant  directives,  Directive
harmonise 
98/37/EC  of  the  European  Parliament  and  of  the
Council  of  22  June  1998  on  the  approximation  of
the 
to
machinery (4),  should  be  appropriately  amended  to
bring  it  into  line  with  this  Directive;

the  Member  States  relating 

laws  of 

the 

(13)  Whereas this Directive should include requirements
regarding  the  design  and  manufacture  of  devices
emitting  ionizing  radiation;  whereas  this  Directive
does not affect the application of Council Directive
96/29/Euratom of 13 May 1996 laying down basic
safety standards for the protection of the health of
workers and the general public against the dangers
arising  from  ionising  radiation (5);

(14)  Whereas, 

since 

electromagnetic 

compatibility
aspects  form  an  integral  part  of  the  essential
requirements  of  this  Directive,  Council  Directive
89/336/EEC of 2 May 1989 on the approximation
of  the  laws  of  the  Member  States  relating  to
electromagnetic compatibility (6)  does  not  apply;

(15)  Whereas,  in  order  to  ease  the  task  of  proving
conformity  with  the  essential  requirements  and  to
enable  conformity  to  be  verified,  it  is  desirable  to
have  harmonised  standards 
in  respect  of  the
prevention  of  risks  associated  with  the  design,
manufacture  and  packaging  of  medical  devices;
whereas  such  harmonised  standards  are  drawn  up
by private-law bodies and should retain their status
as  non-mandatory  texts;  whereas,  to  this  end,  the
European  Committee  for  Standardisation  (CEN)
and  the  European  Committee  for  Electrotechnical
Standardisation  (Cenelec)  are  recognised  as  the
competent  bodies  for  the  adoption  of  harmonised

(1)  OJ  C  136,  4.6.1985,  p.  1.
(2)  OJ  L  189,  20.7.1990,  p.  17.  Directive  as  last  amended  by

Directive  93/68/EEC  (OJ  L  220,  30.8.1993,  p.  1).

(4)  OJ  L  207,  23.7.1998,  p.  1.
(5)  OJ  L  159,  29.6.1996,  p.  1.
(6)  OJ  L  139,  23.5.1989,  p.  19.  Directive  as  last  amended  by

(3)  OJ  L  169,  12.7.1993,  p.  1.

Directive  93/68/EEC  (OJ  L  220,  30.8.1993,  p.  1).

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standards in accordance with the general guidelines
on cooperation between the Commission and those
two  bodies  signed  on  13  November  1984;

date  until  which 
the  device  or  one  of 
components  can  be  used  with  complete  safety;

its

(16)  Whereas,  for  the  purpose  of  this  Directive,  a
harmonised  standard  is  a  technical  specification
(European  standard  of  harmonisation  document)
adopted,  on  a  mandate  from  the  Commission,  by
CEN  or  Cenelec  or  by  both  of  those  bodies  in
accordance  with  Directive  98/34/EC  of 
the
European  Parliament  and  of  the  Council  of  22
June  1998  laying  down  a  procedure  for  the
provision  of  information  in  the  field  of  technical
standards  and  regulations (1),  and  pursuant  to  the
abovementioned general guidelines;

(21)  Whereas,  in  Decision  93/465/EEC  of  22  July  1993
concerning  the  modules  for  the  various  phases  of
the conformity assessment procedures and the rules
for  the  affixing  and  use  of  the  CE  conformity
marking,  which  are  intended  to  be  used  in  the
technical  harmonisation  directives (2),  the  Council
laid  down  harmonised  conformity  assessment
procedures;  whereas  the  details  added  to  these
modules  are 
the
verification required for in vitro diagnostic medical
devices  and  by  the  need  for  consistency  with
Directives  90/385/EEC  and  93/42/EEC;

the  nature  of 

justified  by 

(17)  Whereas,  by  way  of  exception  to  the  general
principles,  the  drawing  up  of  common  technical
specifications takes account of a current practice in
some  Member  States  whereby  for  selected  devices
mainly  used  for  the  evaluation  of  the  safety  of
blood  supply  and  of  organ  donation,  such
specifications are adopted by the public authorities;
whereas  it  is  appropriate  that  these  particular
specifications  should  be  replaced  by  common
technical  specifications;  whereas  these  common
technical 
for
performance  evaluation  and  reevaluation;

specifications 

used 

can 

be 

(18)  Whereas  scientific  experts  from  various  interested
in  the  drafting  of
in 
the
general

parties  could  be 
common 
examination  of  other 
questions;

specifications  and 
specific  or 

technical 

involved 

(19)  Whereas  manufacturing,  as  covered  by 

this
Directive,  also 
includes  the  packaging  of  the
medical device, insofar as such packaging is related
to  the  safety  and  performance  aspects  of  this
device;

(20)  Whereas  certain  devices  have  a  limited  life  owing
to  the  decline  in  their  performance  over  time,
which  is  related,  for  example,  to  the  deterioriation
in  their  physical  or  chemical  properties,  including
the  sterility  or  integrity  of  the  packaging;  whereas
the  manufacturer  should  determine  and  indicate
the period during which the device will perform as
intended;  whereas  the  labelling  should  indicate  the

(22)  Whereas  it  is  necessary,  essentially  for  the  purpose
of  the  conformity  assessment  procedures,  to  group
in  vitro  diagnostic  medical  devices  into  two  main
product  classes;  whereas,  since  the  large  majority
of  such  devices  do  not  constitute  a  direct  risk  to
patients  and  are  used  by  competently  trained
professionals, and the results obtained can often be
confirmed  by  other  means, 
the  conformity
assessment  procedures  can  be  carried  out,  as  a
general  rule,  under  the  sole  responsibility  of  the
manufacturer;  whereas,  taking  account  of  existing
national  regulations  and  of  notifications  received
following  the  procedure  laid  down  in  Directive
98/34/EC,  the  intervention  of  notified  bodies  is
needed  only  for  defined  devices,  the  correct
is  essential  to  medical
performance  of  which 
practice  and  the  failure  of  which  can  cause  a
serious  risk  to  health;

(23)  Whereas,  among  the  in  vitro  diagnostic  medical
devices for which intervention of a notified body is
required,  the  groups  of  products  used  in  blood
transfusion and the prevention of AIDS and certain
types  of  hepatitis  require  a  conformity  assessment
guaranteeing,  with  a  view  to  their  design  and
manufacture,  an  optimum  level  of  safety  and
reliability;

(24)  Whereas  the  list  of  in  vitro  diagnostic  medical
devices  to  be  subjected  to  third-party  conformity
assessment  needs  updating,  taking  account  of
technological  progress  and  of  developments  in  the
field  of  health  protection;  whereas  such  updating
measures  must  be  taken  in  line  with  procedure

(1)  OJ  L  204,  21.7.1998,  p.  37.  Directive  as  last  amended  by

Directive  98/48/EC  (OJ  L  217,  5.8.1998,  p.  18).

(2)  OJ  L  220,  30.8.1993,  p.  23.

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laid  down 

III(a)  as 
in  Council  Decision
87/373/EEC  of  13  July  1987  laying  down  the
procedures 
implementing
powers  conferred  on  the  Commission (1);

the  exercise  of 

for 

(25)  Whereas  an  agreement  on  a  modus  vivendi
between the European Parliament, the Council and
the  Commission  concerning 
implementing
measures  for  acts  adopted  in  accordance  with  the
procedure  laid  down  in  Article  189b  of  the  Treaty
was  reached  on  20  December  1994 (2);

the 

(26)  Whereas  medical  devices  should,  as  a  general  rule,
bear  the  CE  marking  indicating  their  conformity
with the provisions of this Directive to enable them
to  move  freely  within  the  Community  and  to  be
put  into  service  in  accordance  with  their  intended
purpose;

(27)  Whereas  manufacturers  will  be  able,  when  the
intervention  of  a  notified  body  is  required,  to
choose  from  a  list  of  bodies  published  by  the
Commission;  whereas,  although  Member  States  do
not  have  an  obligation  to  designate  such  notified
bodies,  they  must  ensure  that  bodies  designated  as
notified bodies comply with the assessment criteria
laid  down  in  this  Directive;

(28)  Whereas  the  director  and  staff  of  the  notified
bodies  should  not,  themselves  or  through  an
the
intermediary, 
establishments 
and
verification  which  is  likely  to  compromise  their
independence;

in 
assessment 

have 
subject 

interest 

any 

to 

in 

established 

(29)  Whereas  the  competent  authorities  in  charge  of
market  surveillance  should  be  able,  particularly  in
emergencies,  to  contact  the  manufacturer  or  his
representative 
authorised 
the
in  order  to  take  any  protection
Community, 
measures  that  should  prove  necessary;  whereas
cooperation  and  exchange  of  information  between
Member  States  are  necessary  with  a  view  to
uniform  application  of  this  Directive,  in  particular
for  the  purpose  of  market  surveillance;  whereas  to
that  end  it  is  necessary  to  establish  and  manage  a
database  containing  data  on  manufacturers  and
their  authorised  representatives,  on  devices  placed
on  the  market,  on  certificates  issued,  suspended  or

(1)  OJ  L  197,  18.7.1987,  p.  33.
(2)  OJ  C  102,  4.4.1996,  p.  1.

withdrawn,  and  on 
the  vigilance  procedure;
whereas  a  system  of  adverse  incident  reporting
(vigilance  procedure)  constitutes  a  useful  tool  for
surveillance  of 
the
the  market, 
performance  of  new  devices;  whereas  information
obtained  from  the  vigilance  procedure  as  well  as
from  external  quality  assessment  schemes  is  useful
for  decision-making  on  classification  of  devices;

including 

(30)  Whereas  it  is  essential  that  manufacturers  notify
the  competent  authorities  of  the  placing  on  the
market  of  ‘new  products’  with  regard  both  to  the
technology  used  and  the  substances  to  be  analysed
or  other  parameters;  whereas  this 
in
particular  of  high-density  DNA  probe  devices
(known  as  micro-chips)  used  in  genetic  screening;

is  true 

(31)  Whereas,  when  a  Member  State  considers  that,  as
regards a given product or group of products, it is
necessary,  in  order  to  protect  health  and  safety
and/or  ensure  compliance  with  the  imperatives  of
public health, in accordance with Article 36 of the
Treaty,  to  prohibit  or  restrict  their  availability  or
to  subject  it  to  special  conditions,  it  may  take  any
that  are  necessary  and
transitional  measures 
justified;  whereas,  in  such  cases,  the  Commission
consults  the  interested  parties  and  the  Member
States  and,  if  the  national  measures  are  justified,
adopts  the  necessary  Community  measures,  in
accordance  with  procedure  III(a)  as  laid  down  in
Decision  87/373/EEC;

(32)  Whereas  this  Directive  covers  in  vitro  diagnostic
medical devices manufactured from tissues, cells or
substances  of  human  origin;  whereas  it  does  not
refer  to  the  other  medical  devices  manufactured
using  substances  of  human  origin;  whereas,
therefore,  work  will  have  to  continue  in  this
connection 
to  produce  Community
legislation  as  soon  as  possible;

in  order 

it 

(33)  Whereas,  in  view  of  the  need  to  protect  the
integrity of the human person during the sampling,
collection  and  use  of  substances  derived  from  the
is  appropriate  to  apply  the
human  body, 
principles  laid  down  in  the  Convention  of  the
Council  of  Europe  for  the  protection  of  human
rights  and  dignity  of  the  human  being  with  regard
to  the  application  of  biology  and  medicine;
whereas,  furthermore,  national  regulations  relating
to  ethics  continue  to  apply;

(34)  Whereas,  in  the  interests  of  overall  consistency
between directives on medical devices, some of the
provisions of this Directive should be incorporated
into  Directive  93/42/EEC,  which  needs  to  be
amended accordingly;

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(35)  Whereas  it  is  necessary  to  draw  up  as  quickly  as
possible the legislation which is lacking on medical
devices  manufactured  using  substances  of  human
origin,

—  to  determine  the  safety  and  compatibility  with

potential  recipients,  or

—  to  monitor  therapeutic  measures.

HAVE  ADOPTED  THIS  DIRECTIVE:

Article  1

Scope,  definitions

1. This  Directive  shall  apply  to  in  vitro  diagnostic
medical devices and their accessories. For the purposes of
this  Directive,  accessories  shall  be  treated  as  in  vitro
diagnostic  medical  devices  in  their  own  right.  Both  in
vitro  diagnostic  medical  devices  and  accessories  shall
hereinafter  be  termed  devices.

2. For  the  purposes  of  this  Directive,  the  following
definitions  shall  apply:

(a)  ‘medical  device’  means  any  instrument,  apparatus,
appliance,  material  or  other  article,  whether  used
alone  or  in  combination,  including  the  software
necessary  for  its  proper  application,  intended  by  the
manufacturer  to  be  used  for  human  beings  for  the
purpose  of:

—  diagnosis,  prevention,  monitoring,  treatment  or

alleviation  of  disease,

—  diagnosis,  monitoring,  treatment,  alleviation  or

compensation  for  an  injury  or  handicap,

—  investigation,  replacement  or  modification  of  the

anatomy  or  of  a  physiological  process,

—  control  of  conception,

and  which  does  not  achieve  its  principal  intended
action  in  or  on  the  human  body  by  pharmacological,
immunological or metabolic means, but which may be
assisted  in  its  function  by  such  means;

kit, 

(b) ‘in vitro diagnostic medical device’ means any medical
device which is a reagent, reagent product, calibrator,
control  material, 
apparatus,
equipment,  or  system,  whether  used  alone  or  in
combination,  intended  by  the  manufacturer  to  be
used  in  vitro  for  the  examination  of  specimens,
including  blood  and  tissue  donations,  derived  from
the human body, solely or principally for the purpose
of  providing  information:

instrument, 

—  concerning  a  physiological  or  pathological  state,

or

—  concerning  a  congenital  abnormality,  or

Specimen  receptacles  are  considered  to  be  in  vitro
diagnostic  medical  devices.  ‘Specimen  receptacles’  are
those  devices,  whether  vacuum-type  or  not,
specifically  intended  by  their  manufacturers  for  the
primary  containment  and  preservation  of  specimens
derived  from  the  human  body  for  the  purpose  of  in
vitro  diagnostic examination.

Products  for  general  laboratory  use  are  not  in  vitro
diagnostic  medical  devices  unless  such  products,  in
view  of  their  characteristics,  are  specifically  intended
by  their  manufacturer  to  be  used  for 
in  vitro
diagnostic examination;

(c)  ‘accessory’  means  an  article  which,  whilst  not  being
an  in  vitro  diagnostic  medical  device,  is  intended
specifically  by  its  manufacturer  to  be  used  together
with  a  device  to  enable  that  device  to  be  used  in
accordance  with  its  intended  purpose.

For  the  purposes  of  this  definition,  invasive  sampling
devices  or  those  which  are  directly  applied  to  the
human body for the purpose of obtaining a specimen
within  the  meaning  of  Directive  93/42/EEC  shall  not
be  considered  to  be  accessories  to  in  vitro  diagnostic
medical devices;

(d) ‘device  for  self-testing’  means  any  device  intended  by
the manufacturer to be able to be used by lay persons
in  a  home  environment;

(e)  ‘device  for  performance  evaluation’  means  any  device
intended  by  the  manufacturer  to  be  subject  to  one  or
more  performance  evaluation  studies  in  laboratories
for  medical  analyses  or 
in  other  appropriate
environments  outside  his  own  premises;

(f)  ‘manufacturer’ means the natural or legal person with
responsibility  for  the  design,  manufacture,  packaging
and  labelling  of  a  device  before  it  is  placed  on  the
market  under  his  own  name,  regardless  of  whether
these  operations  are  carried  out  by  that  person
himself  or  on  his  behalf  by  a  third  party.

The  obligations  of  this  Directive  to  be  met  by
manufacturers  also  apply  to  the  natural  or  legal
person  who  assembles,  packages,  processes,  fully
refurbishes  and/or  labels  one  or  more  ready-made
products  and/or  assigns  to  them  their 
intended
purpose  as  devices  with  a  view  to  their  being  placed
on 
the  market  under  his  own  name.  This
subparagraph  does  not  apply  to  the  person  who,
while  not  a  manufacturer  within  the  meaning  of  the
first  subparagraph,  assembles  or  adapts  devices

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already  on  the  market  to  their  intended  purpose  for
an  individual  patient;

6. This  Directive  shall  not  affect  national  laws  which
provide 
the  supply  of  devices  by  a  medical
for 
prescription.

(g)  ‘authorised representative’ means any natural or legal
person  established  in  the  Community  who,  explicitly
designated  by  the  manufacturer,  acts  and  may  be
addressed  by  authorities  and  bodies 
the
Community  instead  of  the  manufacturer  with  regard
to  the  latter’s  obligations  under  this  Directive;

in 

7. This  Directive  is  a  specific  directive  within  the
meaning  of  Article  2(2)  of  Directive  89/336/EEC,  which
shall cease to apply to devices which have complied with
this  Directive.

(h) ‘intended purpose’ means the use for which the device
is  intended  according  to  the  data  supplied  by  the
manufacturer  on  the  labelling,  in  the  instructions  for
use  and/or  in  promotional  materials;

(i)  ‘placing  on  the  market’  means  the  first  making
available in return for payment or free of charge of a
device  other  than  a  device  intended  for  performance
evaluation  with  a  view  to  distribution  and/or  use  on
the  Community  market,  regardless  of  whether  it  is
new  or  fully  refurbished;

Article  2

Placing  on  the  market  and  putting  into  service

Member  States  shall  take  all  necessary  steps  to  ensure
that devices may be placed on the market and/or put into
service  only  if  they  comply  with  the  requirements  laid
down  in  this  Directive  when  duly  supplied  and  properly
installed,  maintained  and  used  in  accordance  with  their
intended  purpose.  This 
the  obligation  of
Member  States  to  monitor  the  security  and  quality  of
these  devices.  This  Article  applies  also  to  devices  made
available  for  performance  evaluation.

involves 

(j)  ‘putting  into  service’  means  the  stage  at  which  a
device  has  been  made  available  to  the  final  user  as
being ready for use on the Community market for the
first  time  for  its  intended  purpose.

Article  3

Essential  requirements

Devices  must  meet  the  essential  requirements  set  out  in
Annex  I  which  apply  to  them,  taking  account  of  the
intended  purpose  of  the  devices  concerned.

3. For  the  purposes  of  this  Directive,  calibration  and
control  materials  refer  to  any  substance,  material  or
article  intended  by  their  manufacturer  either  to  establish
measurement  relationships  or  to  verify  the  performance
characteristics  of  a  device 
in  conjunction  with  the
intended  use  of  that  device.

Article  4

Free  movement

4. For  the  purposes  of  this  Directive,  the  removal,
collection  and  use  of  tissues,  cells  and  substances  of
human  origin  shall  be  governed,  in  relation  to  ethics,  by
the principles laid down in the Convention of the Council
of Europe for the protection of human rights and dignity
of  the  human  being  with  regard  to  the  application  of
biology  and  medicine  and  by  any  Member  States
regulations  on  this  matter.

1. Member  States  shall  not  create  any  obstacle  to  the
placing  on  the  market  or  the  putting  into  service  within
their  territory  of  devices  bearing  the  CE  marking
provided for in Article 16 if these devices have undergone
conformity  assessment  in  accordance  with  Article  9.

2. Member  States  shall  not  create  any  obstacle  to
devices  intended  for  performance  evaluation  being  made
available  for  that  purpose  to  the  laboratories  or  other
institutions  listed  in  the  statement  referred  to  in  Annex
VIII if they meet the conditions laid down in Article 9(4)
and  Annex  VIII.

apply 

5. This  Directive 
to  devices
shall  not 
manufactured  and  used  only  within  the  same  health
institution  and  on  the  premises  of  their  manufacture  or
used  on  premises  in  the  immediate  vicinity  without
having been transferred to another legal entity. This does
not  affect  the  right  of  Member  State  to  subject  such
activities  to  appropriate  protection  requirements.

3. At  trade  fairs,  exhibitions,  demonstrations,  scientific
or  technical  gatherings,  etc.  Member  States  shall  not
create  any  obstacle  to  the  showing  of  devices  which  do
not conform to this Directive, provided that such devices
are  not  used  on  specimens  taken  from  the  participants
and  that  a  visible  sign  clearly  indicates  that  such  devices

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cannot  be  marketed  or  put  into  service  until  they  have
been  made  to  comply.

4. Member  States  may  require  the  information  to  be
supplied  pursuant  to  Annex  I,  part  B,  section  8  to  be  in
their  official  language(s)  when  a  device  reaches  the  final
user.

Provided  that  safe  and  correct  use  of  the  device  is
ensured,  Member  States  may  authorise  the  information
referred to in the first subparagraph to be in one or more
other  official  Community  language(s).

In  the  application  of  this  provision,  Member  States  shall
take into account the principle of proportionality and, in
particular:

(a)  whether 

the 

supplied  by
information  can  be 
harmonised  symbols  or  recognised  codes  or  other
measures;

(b) the  type  of  user  anticipated  for  the  device.

5. Where  the  devices  are  subject  to  other  directives
concerning  other  aspects  which  also  provide  for  the
affixing  of  the  CE  marking,  the  latter  shall  indicate  that
the  devices  also  fulfil  the  provisions  of  the  other
directives.

However,  should  one  or  more  of  these  directives  allow
the manufacturer,  during  a  transitional period, to choose
which  arrangements  to  apply,  the  CE  marking  shall
indicate that the devices fulfil the provisions only of those
directives  applied  by  the  manufacturer.  In  this  case,  the
particulars of these directives, as published in the Official
Journal  of  the  European  Communities,  must  be  given  in
the  documents,  notices  or  instructions  required  by  the
directives  and  accompanying  such  devices.

3. Member  States  shall  presume  compliance  with  the
essential  requirements  referred  to  in  Article  3  in  respect
of devices designed and manufactured in conformity with
common technical specifications drawn up for the devices
in List A of Annex II and, where necessary, the devices in
List  B  of  Annex  II.  These  specifications  shall  establish
appropriate  performance  evaluation  and  re-evaluation
criteria,  batch  release  criteria,  reference  methods  and
reference materials.

The  common  technical  specifications  shall  be  adopted  in
accordance  with  the  procedure  mentioned  in  Article  7(2)
and be published in the Official Journal of the European
Communities.

Manufacturers  shall  as  a  general  rule  be  required  to
comply  with  the  common  technical  specifications;  if  for
duly  justified  reasons  manufacturers  do  not  comply  with
those  specifications  they  must  adopt  solutions  of  a  level
at  least  equivalent  thereto.

Where, in this Directive, reference is made to harmonised
standards,  this  is  also  meant  to  refer  to  the  common
technical specifications.

Article  6

Committee  on  Standards  and  Technical  Regulations

1. The  Commission  shall  be  assisted  by  the  committee
set  up  by  Article  5  of  Directive  98/34/EC.

2. The representative of the Commission shall submit to
the  committee  a  draft  of  the  measures  to  be  taken.  The
committee  shall  deliver  its  opinion  on  the  draft  within  a
time  limit  which  the  chairman  may  lay  down  according
to  the  urgency  of  the  matter,  if  necessary  by  taking  a
vote.

Article  5

Reference  to  standards

The opinion shall be recorded in the minutes; in addition,
each Member State shall have the right to ask to have its
position  recorded  in  the  minutes.

1. Member  States  shall  presume  compliance  with  the
essential  requirements  referred  to  in  Article  3  in  respect
of  devices  which  are  in  conformity  with  the  relevant
national  standards  transposing  the  harmonised  standards
the  reference  numbers  of  which  have  been  published  in
the  Official  Journal  of  the  European  Communities;
Member  States  shall  publish  the  reference  numbers  of
such  national  standards.

2.
If  a  Member  State  or  the  Commission  considers  that
the  harmonised  standards  do  not  entirely  meet  the
in  Article  3,  the
essential  requirements  referred  to 
measures  to  be  taken  by  the  Member  States  with  regard
to  these  standards  and  the  publication  referred  to  in
paragraph  1  of  this  Article  shall  be  adopted  by  the
procedure  defined  in  Article  6(2).

The  Commission  shall  take  the  utmost  account  of  the
opinion  delivered  by  the  committee.  It  shall  inform  the
committee  of  the  manner  in  which  its  opinion  has  been
taken  into  account.

Article  7

Committee  on  Medical  Devices

1. The  Commission  shall  be  assisted  by  the  committee
set  up  by  Article  6(2)  of  Directive  90/385/EEC.

2. The representative of the Commission shall submit to
the  committee  a  draft  of  the  measures  to  be  taken.  The

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committee  shall  deliver  its  opinion  on  the  draft  within  a
time  limit  which  the  chairman  may  lay  down  according
to  the  urgency  of  the  matter.  The  opinion  shall  be
delivered  by  the  majority  laid  down  in  Article  148(2)  of
the  Treaty  in  the  case  of  decisions  which  the  Council  is
required  to  adopt  on  a  proposal  from  the  Commission.
The  votes  of  the  representatives  of  the  Member  States
within the committee shall be weighted in the manner set
out  in  that  Article.  The  chairman  shall  not  vote.

The  Commission  shall  adopt  the  measures  envisaged  if
they  are 
the
committee.

in  accordance  with 

the  opinion  of 

If  the  measures  envisaged  are  not  in  accordance  with  the
opinion  of  the  committee,  or  if  no  opinion  is  delivered,
the  Commission  shall,  without  delay,  submit  to  the
Council  a  proposal  relating  to  the  measures  to  be  taken.
The  Council  shall  act  by  a  qualified  majority.

If,  on  the  expiry  of  a  period  of  three  months  from  the
date of referral to the Council, the Council has not acted,
the  proposed  measures  shall  be  adopted  by 
the
Commission.

3. The  committee  referred  to  in  paragraph  1  may
examine any question connected with the implementation
of  this  Directive.

Article  8

Safeguard clause

1. Where  a  Member  State  ascertains  that  the  devices
referred  to  in  Article  4(1),  when  correctly  installed,
maintained  and  used  for  their  intended  purpose  may
compromise the health and/or safety of patients, users or,
where  applicable,  other  persons,  or  the  safety  of
property, it shall take all appropriate interim measures to
withdraw  such  devices  from  the  market  or  prohibit  or
restrict  their  being  placed  on  the  market  or  put  into
service.  The  Member  State  shall  immediately  inform  the
Commission of any such measures, indicating the reasons
for 
in  particular,  whether  non-
compliance  with  this  Directive  is  due  to:

its  decision  and, 

(a)  failure  to  meet  the  essential  requirements  referred  to

in  Article  3;

(b) incorrect  application  of  the  standards  referred  to  in
Article  5,  insofar  as  it  is  claimed  that  the  standards
have  been  applied;

(c)  shortcomings  in  the  standards  themselves.

2. The  Commission  shall  enter  into  consultation  with
the  parties  concerned  as  soon  as  possible.  Where,  after
such  consultation,  the  Commission  finds  that:

to 

is  attributed 

in  paragraph  1 

—  the  measures  are  justified,  it  shall  immediately  so
inform  the  Member  State  which  took  the  initiative
and  the  other  Member  States;  where  the  decision
referred 
to
shortcomings  in  the  standards,  the  Commission  shall,
after  consulting  the  parties  concerned,  bring  the
matter  before  the  committee  referred  to  in  Article
6(1)  within  two  months  if  the  Member  State  which
has taken the decision intends to maintain it and shall
initiate  the  procedures  referred  to  in  Article  6;  where
the measure referred to in paragraph 1 is attributed to
problems related to the contents or to the application
of 
the
technical 
the 
Commission 
the  parties
shall,  after  consulting 
concerned,  bring  the  matter  before  the  Committee
referred  to  in  Article  7(1)  within  two  months,

specifications, 

common 

—  the  measures  are  unjustified,  it  shall  immediately  so
inform  the  Member  State  which  took  the  initiative
authorised
and 
representative.

the  manufacturer 

his 

or 

3. Where a non-complying device bears the CE marking,
the  competent  Member  State  shall  take  appropriate
action against whomsoever affixed the marking and shall
inform  the  Commission  and  the  other  Member  States
thereof.

4. The Commission shall ensure that the Member States
are  kept  informed  of  the  progress  and  outcome  of  this
procedure.

Article  9

Conformity  assessment  procedures

1. For  all  devices  other  than  those  covered  by  Annex  II
and devices for performance evaluation, the manufacturer
shall,  in  order  to  affix  the  CE  marking,  follow  the
procedure  referred  to  in  Annex  III  and  draw  up  the  EC
declaration  of  conformity  required  before  placing  the
devices  on  the  market.

For all devices for self-testing other than those covered by
Annex  II  and  devices  for  performance  evaluation,  the
manufacturer  shall,  prior  to  the  drawing  up  of  the
aforementioned  declaration  of  conformity,  fulfil  the
supplementary requirements set out in Annex III, point 6.
Instead of applying this procedure, the manufacturer may
follow  the  procedure  referred  to  in  paragraphs  2  or  3.

2. For all devices referred to in List A in Annex II other
than  those  intended  for  performance  evaluation,  the
manufacturer  shall,  in  order  to  affix  the  CE  marking
either:

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(a)  follow the procedure relating to the EC declaration of
(full  quality

in  Annex 

IV 

conformity  set  out 
assurance),  or

(b) follow the procedure relating to EC type-examination
set  out  in  Annex  V  coupled  with  the  procedure
relating to the EC declaration of conformity set out in
Annex  VII  (production  quality  assurance).

3. For all devices referred to in List B in Annex II other
than  those  intended  for  performance  evaluation,  the
manufacturer  shall  for  the  purposes  of  affixing  the  CE
marking,  follow  either:

(a)  the  procedure  relating  to  the  EC  declaration  of
(full  quality

in  Annex 

IV 

conformity  set  out 
assurance)  or

(b) the procedure relating to EC type-examination set out

in  Annex  V  couplet  with:

(i)  the procedure relating to EC verification set out in

Annex  VI,  or

(ii) the  procedure  relating  to  the  EC  declaration  of
conformity  set  out  in  Annex  VII  (production
quality assurance).

4.
In the case of devices for performance evaluation, the
manufacturer  shall  follow  the  procedure  referred  to  in
Annex  VIII  and  draw  up  the  statement  set  out  in  that
Annex  before  such  devices  are  made  available.

This  provision  does  not  affect  national  regulations
relating to the ethical aspects of carrying out performance
evaluation  studies  using  tissues  or  substances  of  human
origin.

5. During  the  conformity  assessment  procedure  for  a
device,  the  manufacturer  and,  if  involved,  the  notified
body  shall  take  account  of  the  results  of  any  assessment
and  verification  operations  which,  where  appropriate,
have been carried out in accordance with this Directive at
an  intermediate  state  of  manufacture.

6. The  manufacturer  may 
instruct  his  authorised
representative  to  initiate  the  procedures  provided  for  in
Annexes  III,  V,  VI  and  VIII.

7. The  manufacturer  must  keep  the  declaration  of
conformity,  the  technical  documentation  referred  to  in
Annexes  III  to  VIII,  as  well  as  the  decisions,  reports  and
certificates,  established  by  notified  bodies,  and  make  it
available  to  the  national  authorities  for 
inspection
purposes  for  a  period  ending  five  years  after  the  last
product has been manufactured. Where the manufacturer
is  not  established  in  the  Community,  the  obligation  to
make  the  aforementioned  documentation  available  on
request  applies  to  his  authorised  representative.

8. Where  the  conformity  assessment  procedure  involves
intervention  of  a  notified  body,  the  manufacturer,  or
authorised  representative,  may  apply  to  a  body  of  his
choice within the framework of tasks for which the body
has  been  notified.

information  or  data,  which 

9. The  notified  body  may  require,  where  duly  justified,
for
any 
establishing and maintaining the attestation of conformity
in  view  of  the  chosen  procedure.

is  necessary 

10. Decisions taken by the notified bodies in accordance
with  Annexes  III,  IV,  and  V  shall  be  valid  for  a
maximum  of  five  years  and  may  be  extended  on
application, made at a time agreed in the contract signed
by  both  parties,  for  further  periods  of  up  to  five  years.

11. The  records  and  correspondence  relating  to  the
procedures referred to in paragraphs 1 to 4 shall be in an
official  language  of  the  Member  State  in  which  the
procedures are carried out and/or in another Community
language  acceptable  to  the  notified  body.

12. By  way  of  derogation  from  paragraphs  1  to  4,  the
competent  authorities  may  authorise,  on  duly  justified
request,  the  placing  on  the  market  and  putting  into
service,  within  the  territory  of  the  Member  State
concerned, of individual devices for which the procedures
referred  to  in  paragraphs  1  to  4  have  not  been  carried
out  and  the  use  of  which  is  in  the  interest  of  protection
of  health.

13. The provisions of this Article shall apply accordingly
to any natural or legal person who manufacturers devices
covered  by  this  Directive  and,  without  placing  them  on
the  market,  puts  them  into  service  and  uses  them  in  the
context  of  his  professional  activity.

Article  10

Registration  of  manufacturers  and  devices

1. Any  manufacturer  who  places  devices  on  the  market
under  his  own  name  shall  notify 
the  competent
authorities  of  the  Member  State  in  which  he  has  his
registered  place  of  business:

—  of  the  address  of  the  registered  place  of  business,

—  of 

information  relating  to  the  reagents,  reagent
products  and  calibration  and  control  materials  in
terms  of  common  technological  characteristics  and/or
analytes  and  of  any  significant  change  thereto
including  discontinuation  of  placing  on  the  market;
for  other  devices,  the  appropriate  indications,

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—  in  the  case  of  devices  covered  by  Annex  II  and  of
devices  for  self-testing,  of  all  data  allowing  for
identification  of  such  devices,  the  analytical  and,
where  appropriate,  diagnostic  parameters  as  referred
to  in  Annex  I,  part  A,  section  3,  the  outcome  of
performance  evaluation  pursuant  to  Annex  VIII,
certificates  and  any  significant  change 
thereto,
including  discontinuation  of  placing  on  the  market.

2. For  devices  covered  by  Annex  II  and  for  devices  for
self-testing, Member States may request to be informed of
the  data  allowing  identification  together  with  the  label
and the instructions for use when such devices are placed
on  the  market  and/or  put  into  service  within  their
territory.

These  measures  cannot  constitute  a  precondition  for  the
placing  on  the  market  and/or  putting  into  service  of
devices  which  are  in  conformity  with  this  Directive.

3. Where  a  manufacturer  who  places  devices  on  the
market  under  his  own  name  does  not  have  a  registered
place of business in a Member State, he shall designate an
authorised  representative.  The  authorised  representative
shall  notify  the  competent  authorities  of  the  Member
State  in  which  he  has  his  registered  place  of  business  of
all  particulars  as  referred  to  in  paragraph  1.

4. The  notification  referred  to  in  paragraph  1  shall  also
include any new device. In addition, where, in the context
of  such  notification,  a  device  notified,  bearing  the  CE
marking,  is  a  ‘new  product’,  the  manufacturer  shall
indicate  this  fact  on  his  notification.

For  the  purposes  of  this  Article,  a  device  is  ‘new’  if:

(a)  there  has  been  no  such  device  continuously  available
on  the  Community  market  during  the  previous  three
years  for  the  relevant  analyte  or  other  parameter;

(b) the  procedure 

involves  analytical  technology  not
continuously  used  in  connection  with  a  given  analyte
or other parameter on the Community market during
the  previous  three  years.

5. Member  States  shall  take  all  necessary  measures  to
ensure  that  the  notifications  referred  to  in  paragraphs  1
and  3  are  registered 
in  the  databank
described in Article 12. The procedures for implementing
this  Article  and  in  particular  those  referring  to  the
notification and the concept of significant change shall be
adopted  in  accordance  with  the  procedure  referred  to  in
Article  7.

immediately 

the  establishment  of  a
6. Transitionally,  pending 
European  databank  accessible 
competent
the 
authorities of the Member States and containing the data

to 

relating  to  all  devices  available  on  the  territory  of  the
Community, the manufacturer shall give such notification
to  the  competent  authorities  of  each  Member  State
concerned  by  the  placing  on  the  market.

Article  11

Vigilance  procedure

1. Member  States  shall  take  the  necessary  steps  to
ensure  that  any  information  brought  to  their  knowledge,
in  accordance  with  the  provisions  of  this  Directive,
regarding 
involving
devices bearing the CE marking is recorded and evaluated
centrally:

incidents  mentioned  below 

the 

(a)  any  malfunction,  failure  or  deterioration 

in  the
characteristics and/or performance of a device, as well
as  any  inadequacy  in  the  labelling  or  the  instructions
for  use  which,  directly  or  indirectly,  might  lead  to  or
might have led to the death of a patient, or user or of
other  persons  or  to  a  serious  deterioration  in  their
state  of  health;

(b) any  technical  or  medical  reason  in  relation  to  the
characteristics  or  performance  of  a  device  for  the
reasons  referred  to  in  subparagraph  (a),  leading  to
systematic  recall  of  devices  of  the  same  type  by  the
manufacturer.

2. Where a Member State requires medical practitioners,
the  medical  institutions  or  the  organisers  of  external
quality  assessment  schemes  to  inform  the  competent
authorities of any incidents referred to in paragraph 1, it
shall  take  the  necessary  steps  to  ensure  that  the
manufacturer  of  the  device  concerned,  or  his  authorised
representative,  is  also  informed  of  the  incident.

to  Article  8, 

3. After  carrying  out  an  assessment,  if  possible  together
with  the  manufacturer,  Member  States  shall,  without
prejudice 
the
Commission  and  the  other  Member  States  of  the
for  which
incidents 
appropriate  measures,  including  possible  withdrawal,
have  been  taken  or  are  contemplated.

in  paragraph  1 

immediately 

referred 

inform 

to 

4. Where,  in  the  context  of  notification  referred  to  in
Article 10, a device notified, bearing the CE marking, is a
‘new’  product,  the  manufacturer  shall  indicate  this  fact
on  his  notification.  The  competent  authority  so  notified
may  at  any  time  within  the  following  two  years  and  on
justified  grounds,  require  the  manufacturer  to  submit  a
report  relating  to  the  experience  gained  with  the  device
subsequent  to  its  being  placed  on  the  market.

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5. The  Member  States  shall  on  request  inform  the  other
Member  States  of  the  details  referred  to  in  paragraphs  1
to  4.  The  procedures  implementing  this  Article  shall  be
adopted  in  accordance  with  the  procedure  referred  to  in
Article  7(2).

Article  12

European  databank

1. Regulatory  data  in  accordance  with  this  Directive
shall  be  stored  in  a  European  databank  accessible  to  the
competent  authorities  to  enable  them  to  carry  out  their
tasks  relating  to  this  Directive  on  a  well-informed  basis.

The  databank  shall  contain  the  following:

(a)  data  relating  to  registration  of  manufacturers  and

devices  in  accordance  with  Article  10;

(b) data 

to 

relating 

issued,  modified,
certificates 
supplemented,  suspended,  withdrawn  or  refused
according  to  the  procedure  as  laid  down  in  Annexes
III  to  VII;

(c)  data  obtained 

in  accordance  with  the  vigilance

procedure  as  defined  in  Article  11.

2. Data  shall  be  forwarded  in  a  standardised  format.

3. The  procedures  implementing  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down  in
Article  7(2).

(a)  the  list  of  devices  in  Annex  II  should  be  amended  or

extended,  or

(b) the  conformity  of  a  device  or  category  of  devices
should be established, by way of derogation from the
provisions of Article 9, by applying one or more given
procedures  taken  from  amongst  those  referred  to  in
Article  9,

it  shall  submit  a  duly  substantiated  request  to  the
Commission  and  ask  it  to  take  the  necessary  measures.
The  measures  shall  be  adopted  in  accordance  with  the
procedure  laid  down  in  Article  7(2).

2. When  a  measure  is  to  be  taken  in  accordance  with
paragraph  1,  due  consideration  shall  be  given  to:

(a)  any  relevant  information  available  from  the  vigilance
procedures  and  from  external  quality  assessment
schemes  as  referred  to  in  Article  11;

(b) the  following  criteria:

(i)  whether  total  reliance  has  to  be  placed  on  the
result  obtained  with  a  given  device,  this  result
having  a  direct  impact  on  subsequent  medical
action,  and

(ii)  whether action taken on the basis of an incorrect
result  obtained  using  a  given  device  could  prove
to  be  hazardous  to  the  patient,  to  a  third  party
or  to  the  public,  in  particular  as  a  consequence
of  false  positive  or  false  negative  results,  and

(iii)  whether  the  involvement  of  a  notified  body
the

establishing 

to 

would  be 
conducive 
conformity  of  the  device.

Article  13

Particular  health  monitoring  measures

3. The  Commission  shall  inform  the  Member  States  of
the measures taken and, where appropriate, publish these
measures 
in  the  Official  Journal  of  the  European
Communities.

Where  a  Member  State  considers,  in  relation  to  a  given
product  or  group  of  products,  that,  in  order  to  ensure
protection  of  health  and  safety  and/or  to  ensure  that
public  health  requirements  are  observed  pursuant  to
Article 36 of the Treaty, the availability of such products
should  be  prohibited,  restricted  or  made  subject  to
particular  requirements,  it  may  take  any  necessary  and
justified  transitional  measures.  It  shall  then  inform  the
Commission  and  all  the  other  Member  States,  giving  the
reasons  for  its  decision.  The  Commission  shall  consult
the  interested  parties  and  the  Member  States  and,  where
the  national  measures  are  justified,  adopt  necessary
Community  measures  in  accordance  with  the  procedure
referred  to  in  Article  7(2).

Article  15

Notified  bodies

1. Member States shall notify the Commission and other
Member  States  of  the  bodies  which  they  have  designated
for  carrying  out  the  tasks  pertaining  to  the  procedures
referred  to  in  Article  9  and  the  specific  tasks  for  which
the  bodies  have  been  designated.  The  Commission  shall
assign  identification  numbers  to  these  bodies,  hereinafter
referred  to  as  ‘notified  bodies’.

Article  14

Amendments  to  Annex  II,  and  derogation  clause

1. Where  a  Member  State  considers  that:

The  Commission  shall  publish  a  list  of  the  notified
bodies,  together  with  the  identification  numbers  it  has
allocated to them and the tasks for which they have been
notified, 
in  the  Official  Journal  of  the  European
Communities.  It  shall  ensure  that  the  list  is  kept  up  to
date.

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Member  States  shall  not  be  obliged  to  designate  a
notified  body.

2. Member  States  shall  apply  the  criteria  set  out  in
Annex IX for the designation of bodies. Bodies that meet
the  criteria  laid  down  in  the  national  standards  which
transpose  the  relevant  harmonised  standards  shall  be
presumed  to  meet  the  relevant  criteria.

2. The  CE  marking  of  conformity,  as  shown  in  Annex
X, must appear in a visible, legible and indelible form on
the device, where practicable and appropriate, and on the
instructions for use. The CE marking of conformity must
also appear on the sales packaging. The CE marking shall
be  accompanied  by  the  identification  number  of  the
notified  body  responsible  for  implementation  of  the
procedures  set  out  in  Annexes  III,  IV,  VI  and  VII.

3. Member  States  shall  apply  continual  surveillance  of
notified  bodies  to  ensure  ongoing  compliance  with  the
criteria  set  out  in  Annex  IX.  A  Member  State  that  has
that
notified  a  body 
notification  if  it  finds  that  the  body  no  longer  meets  the
criteria  referred  to  in  Annex  IX.  It  shall  immediately
inform  the  other  Member  States  and  the  Commission  of
any  withdrawal  of  notification  or  any  restriction  placed
on  it.

shall  withdraw  or 

restrict 

3.
It  is  prohibited  to  affix  marks  or  inscriptions  which
are  likely  to  mislead  third  parties  with  regard  to  the
meaning  or  the  graphics  of  the  CE  marking.  Any  other
mark may be affixed to the device, to the packaging or to
the  instruction  leaflet  accompanying  the  device  provided
that  the  visibility  and  legibility  of  the  CE  marking  is  not
thereby  reduced.

4. The  notified  body  and  the  manufacturer,  or  his
authorised  representative  established  in  the  Community,
shall  lay  down,  by  common  accord,  the  time  limits  for
completion  of  the  assessment  and  verification  operations
referred  to  in  Annexes  III  to  VII.

Article  17

Wrongly  affixed  CE  marking

1. Without  prejudice  to  Article  8:

5. The  notified  body  shall  inform  the  other  notified
bodies  and  the  competent  authority  about  all  certificates
suspended  or  withdrawn  and,  on  request,  about
certificates issued or refused. It shall also make available,
on  request,  all  additional  relevant  information.

(a)  where  a  Member  State  establishes  that  the  CE
marking  has  been  wrongly  affixed,  the  manufacturer
or  his  authorised  representative  shall  be  obliged  to
end the infringement under conditions imposed by the
Member  State;

finds 

6. Where  a  notified  body 
that  pertinent
requirements  of  this  Directive  have  not  been  met  or  are
no longer met by the manufacturer or where a certificate
should  not  have  been  issued,  it  shall,  taking  account  of
the principle of proportionality, suspend or withdraw the
certificate  issued  or  place  any  restrictions  on  it  unless
compliance  with  such  requirements  is  ensured  by  the
implementation of appropriate corrective measures by the
manufacturer. In the case of suspension or withdrawal of
the certificate or of any restriction placed on it or in cases
where  an  intervention  of  the  competent  authority  may
become  necessary,  the  notified  body  shall  inform  its
competent  authority  thereof.  The  Member  State  shall
inform  the  other  Member  States  and  the  Commission.

7. The  notified  body  shall,  on  request,  supply  all
relevant information and documents, including budgetary
documents, required to enable the Member State to verify
compliance  with  Annex  IX  requirements.

Article  16

CE  marking

(b) where  non-compliance  continues,  the  Member  State
must  take  all  appropriate  measures  to  restrict  or
prohibit  the  placing  on  the  market  of  the  product  in
question  or  to  ensure  that  it  is  withdrawn  from  the
market,  in  accordance  with  the  procedure  in  Article
8.

2. The  provisions  stated  in  paragraph  1  shall  also  apply
where  the  CE  marking  has  been  affixed  in  accordance
with the procedures in this Directive, but inappropriately,
on  products  that  are  not  covered  by  this  Directive.

Article  18

Decisions  in  respect  of  refusal  or  restriction

1. Any  decision  taken  pursuant  to  this  Directive:

(a)  to  refuse  or  restrict  the  placing  on  the  market  or  any
making  available  or  putting  into  service  of  a  device,
or

than  devices 

1. Devices,  other 
for  performance
evaluation,  considered  to  meet  the  essential  requirements
referred  to  in  Article  3  must  bear  the  CE  marking  of
conformity  when  they  are  placed  on  the  market.

(b) to  withdraw  devices  from  the  market,

shall  state  the  exact  grounds  on  which  it  is  based.  Such
decisions  shall  be  notified  without  delay  to  the  party

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concerned, who shall at the same time be informed of the
remedies available to him under the national law in force
in the Member State in question and of the time limits to
which  such  remedies  are  subject.

2.
In  the  event  of  a  decision  as  referred  to  in  paragraph
1, the manufacturer or his authorised representative shall
have  an  opportunity  to  put  forward  his  point  of  view  in
advance,  unless  such  consultation  is  not  possible  because
of  the  urgency  of  the  measure  to  be  taken  as  justified  in
particular  by  public  health  requirements.

Article  19

Confidentiality

to  observe  confidentiality  with 

Without  prejudice  to  national  law  and  practice  on
medical  secrecy,  Member  States  shall  ensure  that  all  the
parties  involved  in  the  application  of  this  Directive  are
bound 
to
information  obtained  in  carrying  out  their  tasks.  This
does  not  affect  the  obligations  of  Member  States  and
notified  bodies  with  regard  to  mutual  information  and
the  dissemination  of  warnings,  nor  the  obligations  of  the
persons concerned to provide information under criminal
law.

regard 

Article  20

Cooperation  between  Member  States

competent 

Member States shall take appropriate measures to ensure
that 
the
implementation  of  this  Directive  cooperate  with  each
other and convey to each other the information necessary
to  ensure  application  in  compliance  with  this  Directive.

charged  with 

authorities 

derived  from  the  human  body,  solely  or
principally  for  the  purpose  of  providing
information:

—  concerning a physiological or pathological

state,  or

—  concerning  a  congenital  abnormality,  or

—  to  determine  the  safety  and  compatibility

with  potential  recipients,  or

—  to  monitor  therapeutic  measures.

Specimen  receptacles  are  considered  to  be  in
vitro  diagnostic  medical  devices.  “Specimen
receptacles”  are 
those  devices,  whether
vacuum-type  or  not,  specifically  intended  by
their  manufacturers 
primary
containment  and  preservation  of  specimens
derived  from  the  human  body  for  the
purpose  of  in  vitro  diagnostic examination.

the 

for 

Products for general laboratory use are not in
vitro  diagnostic  medical  devices  unless  such
products,  in  view  of  their  characteristics,  are
specifically intended by their manufacturer to
be  used  for  in  vitro  diagnostic examination;’

—  point  (i)  shall  be  replaced  by  the  following:

‘(i)  “putting  into  service”  means  the  stage  at
which  a  device  has  been  made  available  to
the  final  user  as  being  ready  for  use  on  the
Community  market  for  the  first  time  for  its
intended  purpose;’

Article  21

Amendment  of  directives

—  the  following  point  shall  be  added:

1.
In Directive 89/392/EEC, the second indent of Article
1(3),  ‘machinery  for  medical  use,  used  in  direct  contact
with  patients’  shall  be  replaced  by  the  following:

‘— medical devices,’.

2. Directive  93/42/EEC  is  hereby  amended  as  follows:

(a)  in  Article  1(2):

‘(j)  “authorised 

representative”  means 

any
natural  or  legal  person  established  in  the
Community who, explicitly designated by the
manufacturer,  acts  and  may  be  addressed  by
authorities  and  bodies  in  the  Community
instead  of  the  manufacturer  with  regard  to
the  latter’s  obligations  under  this  Directive;’

—  point  (c)  shall  be  replaced  by  the  following:

(b) Article  2  shall  be  replaced  by  the  following:

‘(c)  “in  vitro  diagnostic  medical  device”  means
any  medical  device  which 
is  a  reagent,
reagent  product,  calibrator,  control  material,
instrument,  apparatus,  equipment  or
kit, 
in
used 
system,  whether 
combination,  intended  by  the  manufacturer
to  be  used  in  vitro  for  the  examination  of
specimens, 
tissue
donations,

including  blood  and 

alone 

or 

‘Article  2

Placing  on  the  market  and  putting  into  service

Member States shall take all necessary steps to ensure
that  devices  may  be  placed  on  the  market  and/or  put
into service only if they comply with the requirements
laid  down  in  this  Directive  when  duly  supplied  and

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properly installed, maintained and used in accordance
with  their  intended  purpose.’

(c)  the  following  paragraph  shall  be  added  to  Article

14(1):

‘For all medical devices of classes IIb and III, Member
States may request to be informed of all data allowing
for  identification  of  such  devices  together  with  the
label  and  the  instructions  for  use  when  such  devices
are  put  into  service  within  their  territory.’

(d) the  following  Articles  shall  be  inserted:

‘Article  14a

European  databank

1. Regulatory  data  in  accordance  with  this  Directive
shall  be  stored  in  a  European  database  accessible  to
the competent authorities to enable them to carry out
their 
this  Directive  on  a
to 
tasks 
well-informed  basis.

relating 

The  databank  shall  contain  the  following:

(a)  data  relating  to  registration  of  manufacturers  and

devices  in  accordance  with  Article  14;

(b) data  relating  to  certificates 

issued,  modified,
supplemented,  suspended,  withdrawn  or  refused
according  to  the  procedures,  as  laid  down  in
Annexes  II  to  VII;

(c)  data  obtained  in  accordance  with  the  vigilance

procedure  as  defined  in  Article  10;

Commission  shall,  whenever  possible,  consult  the
interested  parties  and  the  Member  States  and,  where
the  national  measures  are  justified,  adopt  necessary
Community  measures 
the
procedure  referred  to  in  Article  7(2).’

in  accordance  with 

(e)  the  following  paragraphs  shall  be  added  to  Article

16:

‘5. The  notified  body  shall  inform  the  other  notified
bodies  and 
the  competent  authority  about  all
certificates  suspended  or  withdrawn  and,  on  request,
about certificates issued or refused. It shall also make
available,  on 
relevant
information.

request,  all  additional 

6. Where  a  notified  body  finds  that  pertinent
requirements  of  this  Directive  have  not  been  met  or
are  no  longer  met  by  the  manufacturer  or  where  a
certificate should not have been issued, it shall, taking
account  of  the  principle  of  proportionality,  suspend
or  withdraw  the  certificate  issued  or  place  any
restrictions  on 
it  unless  compliance  with  such
requirements  is  ensured  by  the  implementation  of
appropriate  corrective  measures  by  the  manufacturer.
In  the  case  of  suspension  or  withdrawal  of  the
certificate or of any restriction placed on it or in cases
where an intervention of the competent authority may
become  necessary,  the  notified  body  shall  inform  its
competent  authority  thereof.  The  Member  State  shall
the
inform 
Commission.

the  other  Member 

States 

and 

7. The  notified  body  shall,  on  request,  supply  all
including
information  and  documents 
relevant 
budgetary documents, required to enable the Member
State 
compliance  with  Annex  XI
requirements.’

to  verify 

2. Data  shall  be 
format.

forwarded 

in  a  standardised

(f)  the  following  paragraph  shall  be  added  to  Article

18:

3. The  procedures  implementing  this  Article  shall  be
adopted  in  accordance  with  the  procedure  laid  down
in  Article  7(2).’

Article  14b

Particular  health  monitoring  measures

Where  a  Member  State  considers,  in  relation  to  a
given  product  or  group  of  products,  that,  in  order  to
ensure  protection  of  health  and  safety  and/or  to
ensure  that  public  health  requirements  are  observed
pursuant  to  Article  36  of  the  Treaty,  the  availability
of  such  products  should  be  prohibited,  restricted  or
subjected  to  particular  requirements,  it  may  take  any
necessary  and  justified  transitional  measures.  It  shall
then 
inform  the  Commission  and  all  the  other
Member States giving the reasons for its decision. The

‘Those  provisions  shall  also  apply  where  the  CE
marking  has  been  affixed  in  accordance  with  the
procedures  in  this  Directive,  but  inappropriately,  on
products  that  are  not  covered  by  this  Directive.’

(g)  in  Article  22(4),  the  first  subparagraph  shall  be

replaced  by  the  following:

‘4. Member  States  shall  accept:

—  devices  which  conform  to  the  rules  in  force  in
their territory on 31 December 1994 being placed
on  the  market  during  a  period  of  five  years
following  the  adoption  of  this  Directive,  and

—  the  aforementioned  devices  being  put  into  service

until  30  June  2001  at  the  latest.’

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(h) Annex  II,  section  6.2,  Annex  III,  section  7.1,  Annex
V,  section  5.2  and  Annex  VI,  section  5.2  shall  be
deleted;

this Directive. The Member States may take the measures
referred  to  in  Article  15  as  from  the  entry  force  of  this
Directive.

(i)  in Annex XI, section 3 the following sentence shall be

inserted  after  the  second  sentence:

the  availability  of 

‘This  presupposes 
sufficient
scientific  staff  within  the  organisation  who  possess
experience  and  knowledge  sufficient  to  assess  the
medical  functionality  and  performance  of  devices  for
which  it  has  been  notified,  having  regard  to  the
requirements of this Directive and, in particular, those
set  out  in  Annex  I.’

Article  22

Implementation,  transitional  provisions

1. Member  States  shall  adopt  and  publish  the  laws,
regulations  and  administrative  provisions  necessary  to
comply  with  this  Directive  not  later  than  7  December
1999.  They  shall  immediately  inform  the  Commission
thereof.

Member  States  shall  apply  these  provisions  with  effect
from  7  June  2000.

When  Member  States  adopt  these  provisions,  they  shall
contain  a  reference  to  this  Directive  or  shall  be
accompanied by such a reference on the occasion of their
official  publication.  The  methods  of  making  such  a
reference  shall  be  laid  down  by  the  Member  States.

2. Member States shall communicate to the Commission
the  texts  of  the  main  provisions  of  domestic  law  which
they  adopt  in  the  field  governed  by  this  Directive.

in  Article  7  may
3. The  Committee  referred 
undertake  its  tasks  from  the  date  of  entry  into  force  of

to 

4. Member  States  shall  take  the  necessary  action  to
ensure  that  the  notified  bodies  which  are  responsible
pursuant  to  Article  9  for  conformity  assessment  take
account  of  any  relevant 
information  regarding  the
characteristics and performance of such devices, including
in  particular  the  results  of  any  relevant  test  and
verification  already  carried  out  under  pre-existing
national  law,  regulations  or  administrative  provisions  in
respect  of  such  devices.

5. During a period of five years following the entry into
force  of  this  Directive,  Member  States  shall  accept  the
placing  on  the  market  of  devices  which  conform  to  the
rules  in  force  in  their  territory  on  the  date  on  which  this
Directive  enters  into  force.  For  an  additional  period  of
two  years,  the  said  devices  may  be  put  into  service.

Article  23

This  Directive  shall  enter  into  force  on  the  day  of  its
publication  in  the  Official  Journal  of  the  European
Communities.

Article  24

This  Directive  is  addressed  to  the  Member  States.

Done  at  Luxembourg,  27  October  1998.

For  the  European  Parliament

For  the  Council

The  President

The  President

J. M.  GIL-ROBLES

E. HOSTASCH

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ANNEX  I

ESSENTIAL  REQUIREMENTS

A.  GENERAL  REQUIREMENTS

1. 

The  devices  must  be  designed  and  manufactured  in  such  a  way  that,  when  used  under  the
conditions  and  for  the  purposes  intended,  they  will  not  compromise,  directly  or  indirectly,  the
clinical condition or the safety of the patients, the safety or health of users or, where applicable,
other  persons,  or  the  safety  of  property.  Any  risks  which  may  be  associated  with  their  use  must
be  acceptable  when  weighed  against  the  benefits  to  the  patient  and  be  compatible  with  a  high
level  of  protection  of  health  and  safety.

2. 

The  solutions  adopted  by  the  manufacturer  for  the  design  and  construction  of  the  devices  must
conform  to  safety  principles,  taking  account  of  the  generally  acknowledged  state  of  the  art.

In selecting the most appropriate solutions, the manufacturer must apply the following principles
in  the  following  order:

—  eliminate  or  reduce  risks  as  far  as  possible  (inherently  safe  design  and  construction),

—  where  appropriate  take  adequate  protection  measures  in  relation  to  risks  that  cannot  be

eliminated,

—  inform  users  of  the  residual  risks  due  to  any  shortcomings  of  the  protection  measures

adopted.

3. 

4. 

5. 

The  devices  must  be  designed  and  manufactured  in  such  a  way  that  they  are  suitable  for  the
purposes  referred  to  in  Article  1(2)(b),  as  specified  by  the  manufacturer,  taking  account  of  the
generally  acknowledged  state  of  the  art.  They  must  achieve  the  performances,  in  particular,
where  appropriate,  in  terms  of  analytical  sensitivity,  diagnostic  sensitivity,  analytical  specificity,
diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant
interference,  and  limits  of  detection,  stated  by  the  manufacturer.

The  traceability  of  values  assigned  to  calibrators  and/or  control  materials  must  be  assured
through  available  reference  measurement  procedures  and/or  available  reference  materials  of  a
higher  order.

The  characteristics  and  performances  referred  to  in  sections  1  and  3  must  not  be  adversely
affected  to  such  a  degree  that  the  health  or  the  safety  of  the  patient  or  the  user  and,  where
applicable,  of  other  persons,  are  compromised  during  the  lifetime  of  the  device  as  indicated  by
the  manufacturer,  when  the  device  is  subjected  to  the  stresses  which  can  occur  during  normal
conditions  of  use.  When  no  lifetime  is  stated,  the  same  applies  for  the  lifetime  reasonably  to  be
expected of a device of that kind, having regard to the intended purpose and the anticipated use
of  the  device.

The devices must be designed, manufactured and packed in such a way that their characteristics
and  performances  during  their  intended  use  will  not  be  adversely  affected  under  storage  and
transport  conditions  (temperature,  humidity,  etc.)  taking  account  of  the  instructions  and
information  provided  by  the  manufacturer.

B.  DESIGN  AND  MANUFACTURING  REQUIREMENTS

1. 

Chemical  and  physical  properties

1.1.  The  devices  must  be  designed  and  manufactured  in  such  a  way  as  to  achieve  the  characteristics
and  performances  referred  to  in  section  A  on  the  ‘General  requirements’.  Particular  attention
must  be  paid  to  the  possibility  of  impairment  of  analytical  performance  due  to  incompatibility

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between  the  materials  used  and  the  specimens  (such  as  biological  tissues,  cells,  body  fluids  and
micro-organisms)  intended  to  be  used  with  the  device,  taking  account  of  its  intended  purpose.

1.2.  The  devices  must  be  designed,  manufactured  and  packed  in  such  a  way  as  to  reduce  as  far  as
possible the risk posed by product leakage, contaminants and residues to the persons involved in
the  transport,  storage  and  use  of  the  devices,  taking  account  of  the  intended  purpose  of  the
products.

2. 

Infection  and  microbial  contamination

2.1.  The devices and their manufacturing processes must be designed in such a way as to eliminate or
reduce as far as possible the risk of infection to the user or other persons. The design must allow
easy  handling  and,  where  necessary,  reduce  as  far  as  possible  contamination  of,  and  leakage
from, the device during use and, in the case of specimen receptacles, the risk of contamination of
the  specimen.  The  manufacturing  processes  must  be  appropriate  for  these  purposes.

2.2.  Where  a  device  incorporates  biological  substances,  the  risks  of  infection  must  be  reduced  as  far
as possible by selecting appropriate donors and appropriate substances and by using appropriate,
validated  inactivation,  conservation,  test  and  control  procedures.

2.3.  Devices  labelled  either  as  ‘STERILE’  or  as  having  a  special  microbiological  state  must  be
designed, manufactured and packed in an appropriate pack, according to procedures suitable for
ensuring  that  they  remain  in  the  appropriate  microbiological  state  indicated  on  the  label  when
placed on the market, under the storage and transport conditions specified by the manufacturer,
until  the  protective  packaging  is  damaged  or  opened.

2.4.  Devices labelled either as ‘STERILE’ or as having a special microbiological state must have been

processed  by  an  appropriate,  validated  method.

2.5. 

Packaging  systems  for  devices  other  than  those  referred  to  in  section  2.3  must  keep  the  product
without deterioration at the level of cleanliness indicated by the manufacturer and, if the devices
are  to  be  sterilised  prior  to  use,  reduce  as  far  as  possible  the  risk  of  microbial  contamination.

Steps  must  be  taken  to  reduce  as  far  as  possible  microbial  contamination  during  selection  and
handling  of  raw  materials,  manufacture,  storage  and  distribution  where  the  performance  of  the
device  can  be  adversely  affected  by  such  contamination.

2.6.  Devices  intended  to  be  sterilised  must  be  manufactured  in  appropriately  controlled  (e.g.

environmental)  conditions.

2.7. 

Packaging systems for non-sterile devices must keep the product without deterioration at the level
of  cleanliness  stipulated  and,  if  the  devices  are  to  be  sterilised  prior  to  use,  minimise  the  risk  of
microbial contamination; the packaging system must be suitable taking account of the method of
sterilisation  indicated  by  the  manufacturer.

3. 

Manufacturing  and  environmental  properties

3.1. 

If  the  device  is  intended  for  use  in  combination  with  other  devices  or  equipment,  the  whole
combination,  including  the  connection  system,  must  be  safe  and  must  not  impair  the  specified
performances of the devices. Any restrictions on use must be indicated on the label and/or in the
instructions  for  use.

3.2.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  reduce  as  far  as  possible  the
risks linked to their use in conjunction with materials, substances and gases with which they may
come  into  contact  during  normal  conditions  of  use.

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3.3.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  remove  or  reduce  as  far  as

possible:

—  the risk of injury linked to their physical features (in particular aspects of volume x pressure,

dimension  and,  where  appropriate,  ergonomic  features),

—  risks  linked  to  reasonably  foreseeable  external  influences,  such  as  magnetic  fields,  external
electrical  effects,  electrostatic  discharge,  pressure,  humidity,  temperature  or  variations  in
pressure  or  acceleration  or  accidental  penetration  of  substances  into  the  device.

Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  provide  an  adequate  level  of
intrinsic  immunity  of  electromagnetic  disturbance  to  enable  them  to  operate  as  intended.

3.4.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  reduce  as  far  as  possible  the
risks  of  fire  or  explosion  during  normal  use  and  in  single  fault  condition.  Particular  attention
must  be  paid  to  devices  whose  intended  use  includes  exposure  to  or  use  in  association  with
flammable  substances  or  substances  which  could  cause  combustion.

3.5.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  facilitate  the  management  of

safe  waste  disposal.

3.6.  The measuring, monitoring or display scale (including colour change and other visual indicators)
must  be  designed  and  manufactured  in  line  with  ergonomic  principles,  taking  account  of  the
intended  purpose  of  the  device.

4. 

Devices  which  are  instruments  or  apparatus  with  a  measuring  function

4.1.  Devices which are instruments or apparatus having a primary analytical measuring function must
be  designed  and  manufactured  in  such  a  way  as  to  provide  adequate  stability  and  accuracy  of
measurement within appropriate accuracy limits, taking into account the intended purpose of the
device  and  of  available  and  appropriate  reference  measurement  procedures  and  materials.  The
accuracy  limits  have  to  be  specified  by  the  manufacturer.

4.2.  When  values  are  expressed  numerically,  they  must  be  given  in  legal  units  conforming  to  the
provisions  of  Council  Directive  80/181/EEC  of  20  December  1979  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  units  of  measurement (1).

5. 

Protection  against  radiation

5.1.  Devices shall be designed, manufactured and packaged in such a way that exposure of users and

other  persons  to  the  emitted  radiation  is  minimised.

5.2.  When  devices  are  intended  to  emit  potentially  hazardous,  visible  and/or  invisible  radiation,  they

must  as  far  as  possible  be:

—  designed  and  manufactured  in  such  a  way  as  to  ensure  that  the  characteristics  and  the

quantity  of  radiation  emitted  can  be  controlled  and/or  adjusted,

—  fitted  with  visual  displays  and/or  audible  warnings  of  such  emissions.

5.3.  The operating instructions for devices emitting radiation must give detailed information as to the
nature  of  the  emitted  radiation,  means  of  protecting  the  user,  and  on  ways  of  avoiding  misuse
and  of  eliminating  the  risks  inherent  in  installation.

6. 

Requirements  for  medical  devices  connected  to  or  equipped  with  an  energy  source

6.1.  Devices incorporating electronic programmable systems, including software, must be designed to
ensure  the  repeatability,  reliability  and  performance  of  these  systems  according  to  the  intended
use.

(1)  OJ  L  39,  15.2.1980,  p.  40.  Directive  as  last  amended  by  Directive  89/617/EEC  (OJ  L  357,  7.12.1989,  p.  28).

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6.2.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  minimise  the  risks  of  creating
electromagnetic perturbation which could impair the operation of other devices or equipment in
the  usual  environment.

6.3.  Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk
of accidental electric shocks during normal use and in single fault condition, provided the devices
are  installed  and  maintained  correctly.

6.4.  Protection  against  mechanical  and  thermal  risks

6.4.1.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  protect  the  user  against
mechanical  risks.  Devices  must  be  sufficiently  stable  under  the  foreseen  operating  conditions.
They must be suitable to withstand stresses inherent in the foreseen working environment, and to
retain  this  resistance  during  the  expected  life  of  the  devices,  subject  to  any  inspection  and
maintenance  requirements  as  indicated  by  the  manufacturer.

Where there are risks due to the presence of moving parts, risks due to break-up or detachment,
or  leakage  of  substances,  then  appropriate  protection  means  must  be  incorporated.

Any  guards  or  other  means  included  with  the  device  to  provide  protection,  in  particular  against
moving parts, must be secure and must not interfere with access for the normal operation of the
device,  or  restrict  routine  maintenance  of  the  device  as  intended  by  the  manufacturer.

6.4.2.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  reduce  to  the  lowest  possible
level  the  risks  arising  from  vibration  generated  by  the  devices,  taking  account  of  technical
progress  and  of  the  means  available  for  limiting  vibrations,  particularly  at  source,  unless  the
vibrations  are  part  of  the  specified  performance.

6.4.3.  Devices  must  be  designed  and  manufactured  in  such  a  way  as  to  reduce  as  far  as  possible  the
risks  arising  from  the  noise  emitted,  taking  account  of  technical  progress  and  of  the  means
available  to  reduce  noise,  particularly  at  source,  unless  the  noise  emitted  is  part  of  the  specified
performance.

6.4.4.  Terminals  and  connectors  to  electricity,  gas  or  hydraulic  and  pneumatic  energy  supplies  which
the  user  has  to  handle  must  be  designed  and  manufactured  in  such  a  way  as  to  minimise  all
possible  risks.

6.4.5.  Accessible  parts  of  the  devices  (excluding  the  parts  of  areas  intended  to  supply  heat  or  reach
given  temperatures)  and  their  surroundings  must  not  attain  potentially  dangerous  temperatures
under  normal  use.

7. 

Requirements  for  devices  for  self-testing

Devices  for  self-testing  must  be  designed  and  manufactured  in  such  a  way  that  they  perform
appropriately for their intended purpose taking into account the skills and the means available to
users  and  the  influence  resulting  from  variation  that  can  reasonably  be  anticipated  in  users’
technique  and  environment.  The  information  and  instructions  provided  by  the  manufacturer
should  be  easily  understood  and  applied  by  the  user.

7.1.  Devices  for  self-testing  must  be  designed  and  manufactured  in  such  a  way  as  to:

—  ensure  that  the  device  is  easy  to  use  by  the  intended  lay  user  at  all  stages  of  the  procedure,

and

—  reduce  as  far  as  practicable  the  risk  of  user  error  in  the  handling  of  the  device  and  in  the

interpretation  of  the  results.

7.2.  Devices for self-testing must, where reasonably possible, include user control, i.e. a procedure by
which  the  user  can  verify  that,  at  the  time  of  use,  the  product  will  perform  as  intended.

8. 

Information  supplied  by  the  manufacturer

8.1.  Each device must be accompanied by the information needed to use it safely and properly, taking
account  of  the  training  and  knowledge  of  the  potential  users,  and  to  identify  the  manufacturer.

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This  information  comprises  the  data  on  the  label  and  in  the  instructions  for  use.

As  far  as  practicable  and  appropriate,  the  information  needed  to  use  the  device  safely  and
properly must be set out on the device itself and/or, where appropriate, on the sales packaging. If
individual  full  labelling  of  each  unit  is  not  practicable,  the  information  must  be  set  out  on  the
packaging  and/or  in  the  instructions  for  use  supplied  with  one  or  more  devices.

Instructions  for  use  must  accompany  or  be  included  in  the  packaging  of  one  or  more  devices.

In  duly  justified  and  exceptional  cases  no  such  instructions  for  use  are  needed  for  a  device  if  it
can  be  used  properly  and  safely  without  them.

8.2.  Where appropriate, the information to be supplied should take the form of symbols. Any symbol
and identification colour used must conform to the harmonised standards. In areas for which no
standards  exist,  the  symbols  and  colour  used  must  be  described  in  the  documentation  supplied
with  the  device.

8.3. 

In the case of devices containing or a preparation which may be considered as being dangerous,
taking account of the nature and quantity of its constituents and the form under which they are
present,  relevant  danger  symbols  and  labelling  requirements  of  Directive  67/548/EEC (1)  and
Directive 88/379/EEC (2) shall apply. Where there is insufficient space to put all the information
on the device itself or on its label, the relevant danger symbols shall be put on the label and the
other  information  required  by  those  Directives  shall  be  given  in  the  instructions  for  use.

The  provisions  of  the  aforementioned  Directives  on  the  safety  data  sheet  shall  apply,  unless  all
relevant  information  as  appropriate  is  already  made  available  by  the  instructions  for  use.

8.4.  The  label  must  bear  the  following  particulars  which  may  take  the  form  of  symbols  as

appropriate:

(a)  the  name  or  trade  name  and  address  of  the  manufacturer.  For  devices  imported  into  the
Community  with  a  view  to  their  distribution  in  the  Community,  the  label,  the  outer
packaging,  or  the  instructions  for  use  shall  contain  in  addition  the  name  and  address  of  the
authorised  representative  of  the  manufacturer;

(b) the  details  strictly  necessary  for  the  user  to  uniquely  identify  the  device  and  the  contents  of

the packaging;

(c)  where appropriate, the word ‘STERILE’ or a statement indicating any special microbiological

state  or  state  of  cleanliness;

(d) the  batch  code,  preceded  by  the  word  ‘LOT’,  or  the  serial  number;

(e)  if  necessary,  an  indication  of  the  date  by  which  the  device  or  part  of  it  should  be  used,  in
safety,  without  degradation  of  performance,  expressed  as  the  year,  the  month  and,  where
relevant,  the  day,  in  that  order;

(f)  in  case  of  devices  for  performance  evaluation,  the  words  ‘for  performance  evaluation  only’;

(g)  where  appropriate,  a  statement  indicating  the  in  vitro  use  of  the  device;

(h) any  particular  storage  and/or  handling  conditions;

(i)  where  applicable,  any  particular  operating  instructions;

(1)  Council  Directive  67/548/EEC  of  27  June  1967  on  the  approximation  of  laws,  regulations  and  administrative
provisions  relating  to  the  classification,  packaging  and  labelling  of  dangerous  substances  (OJ  196,  16.8.1967,  p.  1).
Directive  as  last  amended  by  Commission  Directive  97/69/EC  (OJ  L  343,  13.12.1997,  p.  19).

(2)  Council  Directive  88/379/EEC  of  7  June  1988  on  the  approximation  of  the  laws,  regulations  and  administrative
provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L
187,  16.7.1988,  p.  14).  Directive  as  last  amended  by  Commission  Directive  96/65/EC  (OJ  L  265,  18.10.1996,  p.
15).

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(j)  appropriate  warnings  and/or  precautions  to  take;

(k) if  the  device  is  intended  for  self-testing,  that  fact  must  be  clearly  stated.

8.5. 

If  the  intended  purpose  of  the  device  is  not  obvious  to  the  user,  the  manufacturer  must  clearly
state  the  intended  purpose  in  the  instructions  for  use  and,  if  appropriate,  on  the  label.

8.6.  Wherever  reasonable  and  practicable,  the  devices  and  separate  components  must  be  identified,
where appropriate in terms of batches, to allow all appropriate action to detect any potential risk
posed  by  the  devices  and  detachable  components.

8.7.  Where  appropriate,  the  instructions  for  use  must  contain  the  following  particulars:

(a)  the  details  referred  to  in  section  8.4  with  the  exception  of  points  (d)  and  (e);

(b) composition  of  the  reagent  product  by  nature  and  amount  or  concentration  of  the  active
ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device
contains  other  ingredients  which  might  influence  the  measurement;

(c)  the  storage  conditions  and  shelf  life  following  the  first  opening  of  the  primary  container,

together  with  the  storage  conditions  and  stability  of  working  reagents;

(d) the  performances  referred  to  in  section  3  of  part  A;

(e)  an  indication  of  any  special  equipment  required  including  information  necessary  for  the

identification  of  that  special  equipment  for  proper  use;

(f)  the  type  of  specimen  to  be  used,  any  special  conditions  of  collection,  pre-treatment  and,  if

necessary,  storage  conditions  and  instructions  for  the  preparation  of  the  patient;

(g)  a  detailed  description  of  the  procedure  to  be  followed  in  using  the  device;

(h) the  measurement  procedure  to  be  followed  with  the  device  including  as  appropriate:

—  the  principle  of  the  method,

—  the  specific  analytical  performance  characteristics  (e.g.  sensitivity,  specificity,  accuracy,
repeatability,  reproducibility,  limits  of  detection  and  measurement  range,  including
information  needed  for  the  control  of  known  relevant  interferences),  limitations  of  the
method and information about the use of available reference measurement procedures and
materials  by  the  user,

—  the details of any further procedure or handling needed before the device can be used (for

example,  reconstitution,  incubation,  dilution,  instrument  checks,  etc.),

—  the  indication  whether  any  particular  training  is  required;

(i)  the  mathematical  approach  upon  which  the  calculation  of  the  analytical  result  is  made;

(j)  measures  to  be  taken  in  the  event  of  changes  in  the  analytical  performance  of  the  device;

(k) information  appropriate  to  users  on:

—  internal  quality  control  including  specific  validation  procedures,

—  the  traceability  of  the  calibration  of  the  device;

(l)  the  reference  intervals  for  the  quantities  being  determined,  including  a  description  of  the

appropriate  reference  population;

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(m) if  the  device  must  be  used  in  combination  with  or  installed  with  or  connected  to  other
medical  devices  or  equipment  in  order  to  operate  as  required  for  its  intended  purpose,
sufficient  details  of  its  characteristics  to  identify  the  correct  devices  or  equipment  to  use  in
order  to  obtain  a  safe  and  proper  combination;

(n) all  the  information  needed  to  verify  whether  the  device  is  properly  installed  and  can  operate
correctly  and  safely,  plus  details  of  the  nature  and  frequency  of  the  maintenance  and
calibration  needed  to  ensure  that  the  device  operates  properly  and  safely;  information  about
safe  waste  disposal;

(o) details  of  any  further  treatment  or  handling  needed  before  the  device  can  be  used  (for

example,  sterilisation,  final  assembly,  etc.);

(p) the  necessary  instructions  in  the  event  of  damage  to  the  protective  packaging  and  details  of

appropriate  methods  of  resterilisation  or  decontamination;

(q) if  the  device  is  reusable,  information  on  the  appropriate  processes  to  allow  reuse,  including
cleaning,  disinfection,  packaging  and  resterilisation  or  decontamination,  and  any  restriction
on  the  number  of  reuses;

(r)  precautions  to  be  taken  as  regards  exposure,  in  reasonably  foreseeable  environmental
conditions,  to  magnetic  fields,  external  electrical  influences,  electrostatic  discharge,  pressure
or  variations  in  pressure,  acceleration,  thermal  ignition  sources,  etc.;

(s)  precautions to be taken against any special, unusual risks related to the use or disposal of the
device  including  special  protective  measures;  where  the  device  includes  substances  of  human
or  animal  origin,  attention  must  be  drawn  to  their  potential  infectious  nature;

(t)  specifications  for  devices  for  self-testing:

—  the results need to be expressed and presented in a way that is readily understood by a lay
person; information needs to be provided with advice to the user on action to be taken (in
case of positive, negative or indeterminate result) and on the possibility of false positive or
false  negative  result,

—  specific  particulars  may  be  omitted  provided  that  the  other  information  supplied  by  the
manufacturer  is  sufficient  to  enable  the  user  to  use  the  device  and  to  understand  the
result(s)  produced  by  the  device,

—  the  information  provided  must  include  a  statement  clearly  directing  that  the  user  should
not  take  any  decision  of  medical  relevance  without  first  consulting  his  or  her  medical
practitioner,

—  the  information  must  also  specify  that  when  the  device  for  self-testing  is  used  for  the
monitoring  of  an  existing  disease,  the  patient  should  only  adapt  the  treatment  if  he  has
received  the  appropriate  training  to  do  so;

(u) date  of  issue  or  latest  revision  of  the  instructions  for  use.

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ANNEX  II

LIST  OF  DEVICES  REFERRED  TO  IN  ARTICLE  9(2)  AND  (3)

List  A

—  Reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  determining  the

following  blood  groups:  ABO  system,  rhesus  (C,  c,  D,  E,  e)  anti-Kell,

—  reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  the  detection,
confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV
I  and  II,  and  hepatitis  B,  C  and  D.

List  B

—  Reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  determining  the

following  blood  groups:  anti-Duffy  and  anti-Kidd,

—  reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  determining

irregular anti-erythrocytic  antibodies,

—  reagents and reagent products, including related calibrators and control materials, for the detection and

quantification  in  human  samples  of  the  following  congenital  infections:  rubella,  toxoplasmosis,

—  reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  diagnosing  the

following  hereditary  disease:  phenylketonuria,

—  reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  determining  the

following  human  infections:  cytomegalovirus,  chlamydia,

—  reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  determining  the

following  HLA  tissue  groups:  DR,  A,  B,

—  reagents  and  reagent  products,  including  related  calibrators  and  control  materials,  for  determining  the

following  tumoral  marker:  PSA,

—  reagents  and  reagent  products,  including  related  calibrators,  control  materials  and  software,  designed

specifically  for  evaluating  the  risk  of  trisomy  21,

—  the following device for self-diagnosis, including its related calibrators and control materials: device for

the  measurement  of  blood  sugar.

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ANNEX  III

EC  DECLARATION  OF  CONFORMITY

1. 

2. 

3. 

The  EC  declaration  of  conformity  is  the  procedure  whereby  the  manufacturer  or  his  authorised
representative  who  fulfils  the  obligations  imposed  by  section  2  to  5  and  additionally,  in  the  case  of
devices  for  self-testing,  the  obligations  imposed  by  section  6,  ensures  and  declares  that  the  products
concerned meet the provisions of this Directive which apply to them. The manufacturer must affix the
CE  marking  in  accordance  with  Article  16.

The  manufacturer  must  prepare  the  technical  documentation  described  in  section  3  and  ensure  that
the  manufacturing  process  follows  the  principles  of  quality  assurance  as  set  out  in  section  4.

The  technical  documentation  must  allow  assessment  of  the  conformity  of  the  product  with  the
requirements  of  the  Directive.  It  must  include  in  particular:

—  a  general  description  of  the  product,  including  any  variants  planned,

—  the  documentation  of  the  quality  system,

—  design  information,  including  the  determination  of  the  characteristics  of  the  basic  materials,
characteristics  and  limitation  of  the  performance  of  the  devices,  methods  of  manufacture  and,  in
the  case  of  instruments,  design  drawings,  diagrams  of  components,  sub-assemblies,  circuits,  etc.,

—  in  the  case  of  devices  containing  tissues  of  human  origin  or  substances  derived  from  such  tissue,
information  on  the  origin  of  such  material  and  on  the  conditions  in  which  it  was  collected,

—  the  descriptions  and  explanations  necessary  to  understand  the  abovementioned  characteristics,

drawings  and  diagrams  and  the  operation  of  the  product,

—  the results of the risk analysis and, where appropriate, a list of the standards referred to in Article
5,  applied  in  full  or  in  part,  and  descriptions  of  the  solutions  adopted  to  meet  the  essential
requirements  of  the  Directive  if  the  standards  referred  to  in  Article  5  have  not  been  applied  in
full,

—  in  the  case  of  sterile  products  or  products  with  a  special  microbiological  state  or  state  of

cleanliness,  a  description  of  the  procedures  used,

—  the  results  of  the  design  calculations  and  of  the  inspections  carried  out,  etc.,

—  if the device is to be combined with other device(s) in order to operate as intended, proof must be
provided  that  it  conforms  to  the  essential  requirements  when  combined  with  any  such  device(s)
having  the  characteristics  specified  by  the  manufacturer,

—  the  test  reports,

—  adequate performance evaluation data showing the performances claimed by the manufacturer and
supported by a reference measurement system (when available), with information on the reference
methods, the reference materials, the known reference values, the accuracy and measurement units
used;  such  data  should  originate  from  studies  in  a  clinical  or  other  appropriate  environment  or
result  from  relevant  biographical  references,

—  the  labels  and  instructions  for  use,

—  the  results  of  stability  studies.

4. 

The manufacturer shall take necessary measures to ensure that the manufacturing process follows the
principles  of  quality  assurance  as  appropriate  for  the  products  manufactured.

The  system  shall  address:

—  the  organisational  structure  and  responsibilities,

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—  the  manufacturing  processes  and  systematic  quality  control  of  production,

—  the  means  to  monitor  the  performance  of  the  quality  system.

5. 

The  manufacturer  shall  institute  and  keep  up  to  date  a  systematic  procedure  to  review  experience
gained  from  devices  in  the  post-production  phase  and  to  implement  appropriate  means  to  apply  any
necessary corrective actions, taking account of the nature and risks in relation to the product. He shall
notify  the  competent  authorities  of  the  following  incidents  immediately  on  learning  of  them:

(i)  any  malfunction,  failure  or  deterioration  in  the  characteristics  and/or  performance  of  a  device,  as
well  as  any  inadequacy  in  the  labelling  or  the  instructions  for  use  which,  directly  or  indirectly,
might lead to, or might have led to, the death of a patient or user or other persons or to a serious
deterioration  in  his  or  their  state  of  health;

(ii) any technical or medical reason connected with the characteristics or the performance of a device
for  the  reasons  referred  to  in  subparagraph  (i)  leading  to  systematic  recall  of  devices  of  the  same
type  by  the  manufacturer.

6. 

For devices for self-testing the manufacturer shall lodge an application for examination of the design
with  a  notified  body.

6.1.  The  application  shall  enable  the  design  of  the  device  to  be  understood  and  shall  enable  conformity

with  the  design-related  requirements  of  the  directive  to  be  assessed.

It  shall  include:

—  test  reports  including,  where  appropriate,  results  of  studies  carried  out  with  lay  persons,

—  data  showing  the  handling  suitability  of  the  device  in  view  of  its  intended  purpose  for

self-testing,

—  the  information  to  be  provided  with  the  device  on  its  label  and  its  instructions  for  use.

6.2.  The notified body shall examine the application and, if the design conforms to the relevant provisions
of this Directive shall issue the applicant with an EC design-examination certificate. The notified body
may  require  the  application  to  be  completed  by  further  tests  or  proof  to  allow  assessment  of
conformity  with  the  design-related  requirements  of  the  Directive.  The  certificate  shall  contain  the
conclusions  of  the  examination,  the  conditions  of  validity,  the  data  needed  for  identification  of  the
approved  design  and,  where  appropriate,  a  description  of  the  intended  purpose  of  the  product.

6.3.  The  applicant  shall  inform  the  notified  body  which  issued  the  EC  design-examination  certificate  of
any  significant  change  made  to  the  approved  design.  Changes  to  the  approved  design  must  receive
further approval from the notified body which issued the EC design-examination certificate wherever
the  changes  could  affect  conformity  with  the  essential  requirements  of  the  Directive  or  with  the
conditions  prescribed  for  use  of  the  product.  This  additional  approval  shall  take  the  form  of  a
supplement  to  the  EC  design-examination  certificate.

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ANNEX  IV

EC  DECLARATION  OF  CONFORMITY

(FULL  QUALITY  ASSURANCE  SYSTEM)

1. 

The manufacturer must ensure application of the quality system approved for the design, manufacture
and final inspection of the devices concerned, as specified in section 3, and is subject to audit as laid
down  in  section  3.3  and  to  the  surveillance  as  specified  in  section  5.  In  addition,  the  manufacturer
must  follow,  for  devices  covered  by  Annex  II,  List  A,  the  procedures  laid  down  in  sections  4  and
6.

2. 

The  declaration  of  conformity  is  the  procedure  whereby  the  manufacturer  who  fulfils  the  obligations
imposed  by  section  1  ensures  and  declares  that  the  devices  concerned  meet  the  provisions  of  this
Directive  which  apply  to  them.

The  manufacturer  shall  affix  the  CE  marking  in  accordance  with  Article  16  and  shall  draw  up  a
declaration  of  conformity  covering  the  devices  concerned.

3.  Quality system

3.1.  The  manufacturer  must  lodge  an  application  for  assessment  of  his  quality  system  with  a  notified

body.

The  application  must  include:

—  the  name  and  address  of  the  manufacturer  and  any  additional  manufacturing  site  covered  by  the

quality system,

—  adequate  information  on  the  device  or  device  category  covered  by  the  procedure,

—  a  written  declaration  that  no  such  application  has  been  lodged  with  any  other  notified  body  for

the  same  device-related  quality  system,

—  the  documentation  on  the  quality  system,

—  an  undertaking  by  the  manufacturer  to  fulfil  the  obligations  imposed  by  the  quality  system

approved,

—  an  undertaking  by  the  manufacturer  to  keep  the  approved  quality  system  adequate  and

efficacious,

—  an  undertaking  by  the  manufacturer  to  institute  and  keep  up  to  date  a  systematic  procedure  to
review experience gained from devices in the post-production phase and to implement appropriate
means to apply any necessary corrective action and notification as referred to in Annex III, section
5.

3.2.  Application  of  the  quality  system  must  ensure  that  the  devices  conform  to  the  provisions  of  this
Directive  which  apply  to  them  at  every  stage,  from  design  to  final  inspection.  All  the  elements,
requirements and provisions adopted by the manufacturer for his quality system must be documented
in  a  systematic  and  orderly  manner  in  the  form  of  written  policies  and  procedures,  such  as  quality
programmes,  quality  plans,  quality  manuals  and  quality  records.

It  shall  include  in  particular  an  adequate  description  of:

(a)  the  manufacturer’s  quality  objectives;

(b) the  organisation  of  the  business  and  in  particular:

—  the  organisational  structures,  the  responsibilities  of  the  managerial  staff  and  their
is
organisational  authority  where  quality  of  design  and  manufacture  of  the  devices 
concerned,

—  the  methods  of  monitoring  the  efficient  operation  of  the  quality  system  and  in  particular  its
ability  to  achieve  the  desired  quality  of  design  and  of  product,  including  control  of  devices
which  fail  to  conform;

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(c)  the  procedures  for  monitoring  and  verifying  the  design  of  the  devices  and  in  particular:

—  a  general  description  of  the  device,  including  any  variants  planned,

—  all  documentation  referred  to  in  Annex  III,  section  3,  indents  3  to  13,

—  in  the  case  of  devices  for  self-testing,  the  information  referred  to  in  Annex  III,  section  6.1,

—  the techniques used to control and verify the design and the processes and systematic measures

which  will  be  used  when  the  devices  are  being  designed;

(d) the  inspection  and  quality  assurance  techniques  at  the  manufacturing  stage  and  in  particular:

—  the  processes  and  procedures  which  will  be  used,  particularly  as  regards  sterilisation,

—  the  procedures  in  relation  to  purchasing,

—  the  product  identification  procedures  drawn  up  and  kept  up  to  date  from  drawings,

specifications  or  other  relevant  documents  at  every  stage  of  manufacture;

(e)  the appropriate tests and trials which will be carried out before, during and after manufacture, the
frequency  with  which  they  will  take  place,  and  the  test  equipment  used;  it  must  be  possible  to
trace  back  the  calibration.

The  manufacturer  shall  carry  out  the  required  controls  and  tests  according  to  the  latest  state  of  the
art. The controls and tests shall cover the manufacturing process including the characterisation of the
raw  material  and  the  individual  devices  or  each  batch  of  devices  manufactured.

In testing the devices covered by Annex II, List A, the manufacturer shall take into account the most
recent  available  information,  in  particular  as  regards  the  biological  complexity  and  variability  of  the
specimens  to  be  tested  with  the  in  vitro  device concerned.

3.3.  The  notified  body  must  audit  the  quality  system  to  determine  whether  it  meets  the  requirements
referred  to  in  section  3.2.  It  must  presume  that  quality  systems  which  implement  the  relevant
harmonised  standards  conform  to  the  requirements.

The  assessment  team  must  have  experience  of  assessments  of  the  technology  concerned.  The
assessment  procedure  must  include  an  inspection  on  the  manufacturer’s  premises  and,  in  duly
substantiated  cases,  on  the  premises  of  the  manufacturer’s  suppliers  and/or  subcontractors  to  inspect
the  manufacturing  processes.

The  decision  shall  be  notified  to  the  manufacturer.  It  must  contain  the  conclusions  of  the  inspection
and  a  reasoned  assessment.

3.4.  The  manufacturer  must  inform  the  notified  body  which  approved  the  quality  system  of  any  plan  for

substantial  changes  to  the  quality  system  or  the  product-range  covered.

The notified body must assess the changes proposed and verify whether after these changes the quality
system  still  meets  the  requirements  referred  to  in  section  3.2.  It  must  notify  the  manufacturer  of  its
decision.  This  decision  must  contain  the  conclusions  of  the  inspection  and  a  reasoned  assessment.

4. 

Examination  of  the  design  of  the  product

4.1.  For  devices  covered  by  Annex  II,  List  A,  in  addition  to  the  obligations  imposed  by  section  3,  the
manufacturer must lodge with the notified body an application for examination of the design dossier
relating  to  the  device  which  he  plans  to  manufacture  and  which  falls  into  the  category  referred  to  in
section  3.1.

4.2.  The application must describe the design, manufacture and performances of the device in question. It
must include the documents needed to assess whether the device conforms to the requirements of this
Directive,  as  referred  to  in  section  3.2(c).

4.3.  The notified body must examine the application and, if the device conforms to the relevant provisions
of  the  Directive,  issue  the  application  with  an  EC  design-examination  certificate.  The  notified  body
may  require  the  application  to  be  completed  by  further  tests  or  proof  to  allow  assessment  of
conformity with the requirements of the Directive. The certificate must contain the conclusions of the
examination, the conditions of validity, the data needed for the identification of the approved design
and,  where  appropriate,  a  description  of  the  intended  purpose  of  the  device.

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4.4.  Changes  to  the  approved  design  must  receive  further  approval  from  the  notified  body  which  issued
the EC design-examination certificate wherever the changes could affect conformity with the essential
requirements  of  the  Directive  or  with  the  conditions  prescribed  for  use  of  the  device.  The  applicant
shall inform the notified body which issued the EC design-examination certificate of any such changes
made to the approved design. The additional approval must take the form of a supplement to the EC
design-examination certificate.

4.5.  The  manufacturer  shall  inform  the  notified  body  without  delay  if  it  has  obtained  information  about
changes  to  the  pathogen  and  markers  of  infections  to  be  tested,  in  particular  as  a  consequence  of
biological  complexity  and  variability.  In  this  connection,  the  manufacturer  shall  inform  the  notified
body  whether  any  such  change  is  likely  to  affect  the  performance  of  the  in  vitro  diagnostic  medical
device concerned.

5. 

Surveillance

5.1.  The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the

approved  quality  system.

5.2.  The  manufacturer  must  authorise  the  notified  body  to  carry  out  all  the  necessary  inspections  and

supply  it  with  all  relevant  information,  in  particular:

—  the  documentation  on  the  quality  system,

—  the  data  stipulated  in  the  part  of  the  quality  system  relating  to  design,  such  as  the  results  of

analyses,  calculation,  tests,  etc.,

—  the  data  stipulated  in  the  part  of  the  quality  system  relating  to  manufacture,  such  as  inspection
reports  and  test  data,  calibration  data,  qualification  reports  of  the  personnel  concerned,  etc.

5.3.  The  notified  body  must  periodically  carry  out  appropriate  inspections  and  assessments  to  make  sure
that the manufacturer applies the approved quality system and must supply the manufacturer with an
assessment  report.

5.4. 

In  addition,  the  notified  body  may  pay  unannounced  visits  to  the  manufacturer.  At  the  time  of  such
visits,  the  notified  body  may,  where  necessary,  carry  out  or  ask  for  tests  in  order  to  check  that  the
quality system is working properly. It must provide the manufacturer with an inspection report and, if
a  test  has  been  carried  out,  with  a  test  report.

6. 

Verification  of  manufactured  products  covered  by  Annex  II,  List  A

6.1. 

In  the  case  of  devices  covered  by  Annex  II,  List  A,  the  manufacturer  shall  forward  to  the  notified
body  without  delay  after  the  conclusion  of  the  controls  and  tests  the  relevant  reports  on  the  tests
carried out on the manufactured devices or each batch of devices. Furthermore, the manufacturer shall
make  the  samples  of  manufactured  devices  or  batches  of  devices  available  to  the  notified  body  in
accordance  with  pre-agreed  conditions  and  modalities.

6.2.  The manufacturer may place the devices on the market, unless the notified body communicates to the
manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples,
any  other  decision,  including  in  particular  any  condition  of  validity  of  delivered  certificates.

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ANNEX  V

EC  TYPE-EXAMINATION

1. 

2. 

EC type-examination is the part of the procedure whereby a notified body ascertains and certifies that
a  representative  sample  of  the  production  envisaged  fulfils  the  relevant  provisions  of  this  Directive.

The  application  for  EC  type-examination  shall  be  lodged  by  the  manufacturer  or  by  his  authorised
representative  with  a  notified  body.

The  application  shall  include:

—  the  name  and  the  address  of  the  manufacturer  and  the  name  and  address  of  the  authorised

representative  if  the  application  is  lodged  by  the  representative,

—  the  documentation  described  in  section  3  needed  to  assess  the  conformity  of  the  representative
sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of
this Directive. The applicant shall make a ‘type’ available to the notified body. The notified body
may  request  other  samples  as  necessary,

—  a  written  declaration  that  no  application  has  been  lodged  with  any  other  notified  body  for  the

same  type.

3. 

The  documentation  must  allow  an  understanding  of  the  design,  the  manufacture  and  the
performances  of  the  device.  The  documentation  shall  contain  the  following  items  in  particular:

—  a  general  description  of  the  type,  including  any  variants  planned,

—  all  documentation  referred  to  in  Annex  III,  section  3,  indents  3  to  13,

—  in  the  case  of  devices  for  self  testing,  the  information  referred  to  in  Annex  III,  section  6.1.

4. 

The  notified  body  shall:

4.1.  examine and assess the documentation and verify that the type has been manufactured in conformity
with  that  documentation;  it  shall  also  record  the  items  designed  in  conformity  with  the  applicable
provisions  of  the  standards  referred  to  in  Article  5,  as  well  as  the  items  not  designed  on  the  basis  of
the  relevant  provisions  of  the  abovementioned  standards;

4.2.  perform  or  have  performed  appropriate  examinations  and  the  tests  necessary  to  verify  whether  the
solutions  adopted  by  the  manufacturer  meet  the  essential  requirements  of  this  Directive  if  the
standards  referred  to  in  Article  5  have  not  been  applied;  if  the  device  is  to  be  combined  with  other
device(s)  in  order  to  operate  as  intended,  proof  must  be  provided  that  it  conforms  to  the  essential
requirements  when  combined  with  any  such  device(s)  having  the  characteristics  specified  by  the
manufacturer;

4.3.  carry  out  or  ask  for  the  appropriate  examinations  and  the  tests  necessary  to  verify  whether,  if  the

manufacturer  has  chosen  to  apply  the  relevant  standards,  these  have  actually  been  applied;

4.4.  agree  with  the  applicant  on  the  place  where  the  necessary  examinations  and  tests  will  be  carried

out.

5. 

6. 

If the type conforms to the provisions of this Directive, the notified body shall issue the applicant with
an  EC  type-examination  certificate.  The  certificate  shall  contain  the  name  and  address  of  the
manufacturer,  the  conclusions  of  the  examination,  the  conditions  of  validity  and  the  data  needed  for
identification  of  the  type  approved.  The  relevant  parts  of  the  documentation  shall  be  annexed  to  the
certificate  and  a  copy  shall  be  kept  by  the  notified  body.

The  manufacturer  shall  inform  the  notified  body  without  delay  if  it  has  obtained  information  about
changes  to  the  pathogen  and  markers  of  infections  to  be  tested,  in  particular  as  a  consequence  of
biological  complexity  and  variability.  In  this  connection,  the  manufacturer  shall  inform  the  notified
body  whether  any  such  change  is  likely  to  affect  the  performance  of  the  in  vitro  device concerned.

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6.1.  Changes to the approved device must receive further approval from the notified body which issued the
EC  type-examination  certificate  wherever  the  changes  may  affect  conformity  with  the  essential
requirements  of  the  Directive  or  with  the  conditions  prescribed  for  use  of  the  device.  The  applicant
shall  inform  the  notified  body  which  issued  the  EC  type-examination  certificate  of  any  such  change
made to the approved device. This new approval shall take the form of a supplement to the initial EC
type-examination certificate.

7. 

Administrative provisions

Other  notified  bodies  may  obtain  a  copy  of  the  EC  type-examination  certificates  and/or  the
supplements thereto. The annexes to the certificates must be available to the other notified bodies on
reasoned  application,  after  the  manufacturer  has  been  informed.

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ANNEX  VI

EC  VERIFICATION

1. 

EC  verification  is  the  procedure  whereby  the  manufacturer  or  his  authorised  representative  ensures
and declares that the products which have been subject to the procedure set out in section 4 conform
to  the  type  described  in  the  EC  type-examination  certificate  and  meet  the  requirements  of  this
Directive  which  apply  to  them.

2.1.  The  manufacturer  must  take  all  the  measures  necessary  to  ensure  that  the  manufacturing  process
produces products which conform to the type described in the EC type-examination certificate and the
requirements of the Directive which apply to them. Before the start of manufacture, the manufacturer
must prepare documents defining the manufacturing process, in particular as regards sterilisation and
the  suitability  of  starting  materials,  where  necessary,  and  define  the  necessary  testing  procedures
according  to  the  state  of  the  art.  All  the  routine,  pre-established  provisions  must  be  implemented  to
ensure  homogeneous  production  and  conformity  of  the  products  with  the  type  described  in  the  EC
type-examination  certificate  and  with  the  requirements  of  this  Directive  which  apply  to  them.

2.2.  To  the  extent  that  for  certain  aspects  the  final  testing  according  to  section  6.3  is  not  appropriate,
adequate  process  testing,  monitoring  and  control  methods  shall  be  established  by  the  manufacturer
with the approval of the notified body. The provisions of Annex IV, section 5, shall apply accordingly
in  relation  to  the  abovementioned  approved  procedures.

3. 

4. 

The  manufacturer  must  undertake  to  institute  and  keep  up  to  date  a  systematic  procedure  to  review
experience gained from devices in the post-production phase and to implement appropriate means to
apply  any  necessary  corrective  and  notification  action  as  referred  to  in  Annex  III,  section  5.

The notified body must carry out the appropriate examinations and tests taking account of section 2.2
in  order  to  verify  the  conformity  of  the  product  with  the  requirements  of  the  Directive  either  by
examining and testing every product as specified in section 5 or by examining and testing products on
a  statistical  basis  as  specified  in  section  6,  as  the  manufacturer  decides.  When  carrying  out  statistical
verification  according  to  section  6,  the  notified  body  has  to  decide  when  statistical  procedures  for
lot-by-lot  inspection  or  isolated  lot  inspection  have  to  be  applied.  Such  decision  must  be  taken  in
consultation  with  the  manufacturer.

In  as  far  as  the  conduct  of  examinations  and  tests  on  a  statistical  basis  is  not  appropriate,
examinations  and  tests  may  be  carried  out  on  a  random  basis  provided  that  such  procedure  in
conjunction  with  the  measures  taken  in  accordance  with  section  2.2  ensures  an  equivalent  level  of
conformity.

5. 

Verification  by  examination  and  testing  of  every  product

5.1.  Every  product  is  examined  individually  and  the  appropriate  tests  defined  in  the  relevant  standard(s)
referred to in Article 5 or equivalent tests must be carried out in order to verify the conformity of the
products with the EC type described in the type-examination certificate and with the requirements of
the  Directive  which  apply  to  them.

5.2.  The notified body must affix, or have affixed, its identification number to each approved product and

must  draw  up  a  written  certificate  of  conformity  relating  to  the  tests  carried  out.

6. 

Statistical verification

6.1.  The  manufacturer  must  present  the  manufactured  products  in  the  form  of  homogeneous  batches.

6.2.  One or more random samples, as necessary, are taken from each batch. The products which make up
the  sample  are  examined  and  the  appropriate  tests  defined  in  the  relevant  standard(s)  referred  to  in
Article  5  or  equivalent  tests  must  be  carried  out  to  verify,  where  appropriate,  the  conformity  of  the
products with the type described in the EC type-examination certificate and with the requirements of
the  Directive  which  apply  to  them  in  order  to  determine  whether  to  accept  or  reject  the  batch.

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6.3.  Statistical control of products will be based on attributes and/or variables, entailing sampling schemes
with operational characteristics which ensure a high level of safety and performance according to the
state  of  the  art.  The  sampling  scheme  will  be  established  by  the  harmonised  standards  referred  to  in
Article  5,  taking  account  of  the  specific  nature  of  the  product  categories  in  question.

6.4. 

If  the  batch  is  accepted,  the  notified  body  affixes,  or  has  affixed  its  identification  number  to  each
product and draws up a written certificate of conformity relating to the tests carried out. All products
in  the  batch  may  be  put  on  the  market  except  any  in  the  sample  which  failed  to  conform  .

If  the  batch  is  rejected  the  competent  notified  body  must  take  appropriate  measures  to  prevent  the
batch from being placed on the market. In the event of frequent rejection of batches, the notified body
may  suspend  the  statistical  verification.

The  manufacturer  may,  on  the  responsibility  of  the  notified  body,  affix  the  notified  body’s
identification  number  during  the  manufacturing  process.

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ANNEX  VII

EC  DECLARATION  OF  CONFORMITY

(PRODUCTION  QUALITY  ASSURANCE)

1. 

2. 

The manufacturer must ensure application of the quality system approved for the manufacture of the
devices  concerned  and  carry  out  the  final  inspection,  as  specified  in  section  3,  and  is  subject  to  the
surveillance  referred  to  in  section  4.

The  declaration  of  conformity  is  the  part  of  the  procedure  whereby  the  manufacturer  who  fulfils  the
obligations  imposed  by  section  1  ensures  and  declares  that  the  products  concerned  conform  to  the
type described in the EC type-examination certificate and meet the provisions of this Directive which
apply  to  them.

The  manufacturer  must  affix  the  CE  marking  in  accordance  with  Article  16  and  draw  up  a
declaration  of  conformity  covering  the  devices  concerned.

3.  Quality system

3.1.  The  manufacturer  must  lodge  an  application  for  assessment  of  his  quality  system  with  a  notified

body.

The  application  must  include:

—  all  documentation  and  undertakings  referred  to  in  Annex  IV,  section  3.1,  and

—  the  technical  documentation  on  the  types  approved  and  a  copy  of  the  EC  type-examination

certificates.

3.2.  Application  of  the  quality  system  must  ensure  that  the  devices  conform  to  the  type  described  in  the

EC  type-examination  certificate.

All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  for  his  quality  system
must be documented in a systematic and orderly manner in the form of written policy statements and
procedures.  This  quality  system  documentation  must  permit  uniform  interpretation  of  the  quality
policy  and  procedures  such  as  quality  programmes,  plans,  manuals  and  records.

It  must  include  in  particular  an  adequate  description  of:

(a)  the  manufacturer’s  quality  objectives;

(b) the  organisation  of  the  business  and  in  particular:

—  the  organisational  structures,  the  responsibilities  of  the  managerial  staff  and  their

organisational  authority  where  quality  of  manufacture  of  the  devices  is  concerned,

—  the  methods  of  monitoring  the  efficient  operation  of  the  quality  system  and  in  particular  its
ability  to  achieve  the  desired  quality  of  product,  including  control  of  devices  which  fail  to
conform;

(c)  the  inspection  and  quality  assurance  techniques  at  the  manufacturing  stage  and  in  particular:

—  the  processes  and  procedures  which  will  be  used,  particularly  as  regards  sterilisation,

—  the  procedures  in  relation  to  purchasing,

—  the  product  identification  procedures  drawn  up  and  kept  up  to  date  from  drawings,

specifications  or  other  relevant  documents  at  every  stage  of  manufacture;

(d) the  appropriate  tests  and  trials  to  be  carried  out  before,  during  and  after  manufacture,  the
frequency  with  which  they  will  take  place,  and  the  test  equipment  used;  it  must  be  possible  to
trace  back  the  calibration.

3.3.  The  notified  body  must  audit  the  quality  system  to  determine  whether  it  meets  the  requirements
referred  to  in  section  3.2.  It  must  presume  that  quality  systems  which  implement  the  relevant
harmonised  standards  conform  to  these  requirements.

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The  assessment  team  must  have  past  experience  of  assessments  of  the  technology  concerned.  The
assessment  procedure  must  include  an  inspection  on  the  manufacturer’s  premises  and,  in  duly
substantiated  cases,  on  the  premises  of  the  manufacturer’s  suppliers  and/or  subcontractors  to  inspect
the  manufacturing  processes.

The  decision  must  be  notified  to  the  manufacturer.  It  must  contain  the  conclusions  of  the  inspection
and  a  reasoned  assessment.

3.4.  The  manufacturer  shall  inform  the  notified  body  which  approved  the  quality  system  of  any  plan  for

substantial  changes  to  the  quality  system.

The notified body must assess the changes proposed and verify whether after these changes the quality
system  still  meets  the  requirements  referred  to  in  section  3.2.  It  must  notify  the  manufacturer  of  its
decision.  This  decision  must  contain  the  conclusions  of  the  inspection  and  a  reasoned  assessment.

4. 

Surveillance

The  provision  of  Annex  IV,  section  5,  shall  apply.

5. 

Verification  of  manufactured  products  covered  by  Annex  II,  List  A

5.1. 

In  the  case  of  devices  covered  by  Annex  II,  List  A,  the  manufacturer  shall  forward  to  the  notified
body  without  delay  after  the  conclusion  of  the  controls  and  tests  the  relevant  reports  on  the  tests
carried out on the manufactured devices or each batch of devices. Furthermore, the manufacturer shall
make  the  samples  of  manufactured  devices  or  batches  of  devices  available  to  the  notified  body  in
accordance  with  pre-agreed  conditions  and  modalities.

5.2.  The manufacturer may place the devices on the market, unless the notified body communicates to the
manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples,
any  other  decision,  including  in  particular  any  condition  of  validity  of  delivered  certificates.

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ANNEX  VIII

STATEMENT  AND  PROCEDURES  CONCERNING  DEVICES  FOR  PERFORMANCE  EVALUATION

1.  For devices for performance evaluation the manufacturer or his authorised representative shall draw up
the statement containing the information stipulated in section 2 and ensure that the relevant provisions
of  this  Directive  are  met.

2.  The  statement  shall  contain  the  following  information:

—  data  allowing  identification  of  the  device  in  question,

—  an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of

the  evaluation  and  number  of  devices  concerned,

—  the  list  of  laboratories  or  other  institutions  taking  part  in  the  evaluation  study,

—  the  starting  date  and  scheduled  duration  for  the  evaluations  and,  in  the  case  of  devices  for

self-testing,  the  location  and  number  of  lay  persons  involved,

—  a statement that the device in question conforms to the requirements of the Directive, apart from the
aspects  covered  by  the  evaluation  and  apart  from  those  specifically  itemised  in  the  statement,  and
that  every  precaution  has  been  taken  to  protect  the  health  and  safety  of  the  patient,  user  and  other
persons.

3.  The  manufacturer  shall  also  undertake  to  keep  available  for  the  competent  national  authorities  the
documentation allowing an understanding of the design, manufacture and performances of the product,
including  the  expected  performances,  so  as  to  allow  assessment  of  conformity  with  the  requirements  of
this  Directive.  This  documentation  must  be  kept  for  a  period  ending  at  least  five  years  after  the  end  of
the  performance  evaluation.

The manufacturer shall take all the measures necessary for the manufacturing process to ensure that the
products  manufactured  conform  to  the  documentation  mentioned  in  the  first  paragraph.

4.  The  provisions  of  Article  10(1),  (3)  and  (5)  shall  apply  to  devices  intended  for  performance

evaluation.

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ANNEX  IX

CRITERIA  FOR  THE  DESIGNATION  OF  NOTIFIED  BODIES

1.  The  notified  body,  its  director  and  the  assessment  and  verification  staff  shall  not  be  the  designer,
manufacturer,  supplier,  installer  or  user  of  the  devices  which  they  inspect,  nor  the  authorised
representative  of  any  of  these  persons.  They  may  not  be  directly  involved  in  the  design,  construction,
marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no
way  precludes  the  possibility  of  exchanges  of  technical  information  between  the  manufacturer  and  the
body.

2.  The  notified  body  and  its  staff  must  carry  out  the  assessment  and  verification  operations  with  the
highest degree of professional integrity and the requisite competence in the field of medical devices and
must  be  free  from  all  pressures  and  inducements,  particularly  financial,  which  might  influence  their
judgment  or  the  results  of  the  inspection,  especially  from  persons  or  groups  of  persons  with  an  interest
in  the  results  of  the  verifications.

Should the notified body subcontract specific tasks connected with the establishment and verification of
the  facts,  it  must  first  ensure  that  the  subcontractor  meets  the  provisions  of  the  Directive.  The  notified
body  shall  keep  at  the  disposal  of  the  national  authorities  the  relevant  documents  assessing  the
subcontractor’s  qualifications  and  the  work  carried  out  by  the  subcontractor  under  this  Directive.

3.  The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes III
to VII and for which it has been notified, whether these tasks are carried out by the body itself or on its
responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform
properly the technical and administrative tasks entailed in assessment and verification. This includes the
availability  of  sufficient  scientific  staff  within  the  organisation  who  possess  adequate  experience  and
knowledge  necessary  to  assess  the  biological  and  medical  functionality  and  performance  of  devices  for
which  it  has  been  notified,  in  relation  to  the  requirements  of  this  Directive  and,  in  particular,  with
Annex  I  requirements.  The  notified  body  must  also  have  access  to  the  equipment  necessary  for  the
verifications required.

4.  The  inspection  staff  must  have:

—  sound vocational training covering all the assessment and verification operations for which the body

has  been  designated,

—  satisfactory knowledge of the rules on the inspections which they carry out and adequate experience

of  such  inspections,

—  the  ability  required  to  draw  up  the  certificates,  records  and  reports  to  demonstrate  that  the

inspections  have  been  carried  out.

5.  The impartiality of the inspection staff must be guaranteed. Their remuneration must not depend on the

number  of  inspections  carried  out,  nor  on  the  results  of  the  inspections.

6.  The  body  must  take  out  civil  liability  insurance,  unless  liability  is  assumed  by  the  State  under  domestic

legislation  or  the  Member  State  itself  carries  out  the  inspections  directly.

7.  The staff of the inspection body are bound to observe professional secrecy with regard to all information
gained in the course of their duties (except vis-à-vis the competent administrative authorities of the State
in which their activities are carried out) under this Directive or any provision of national law putting it
into  effect.

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ANNEX  X

CE  MARKING  OF  CONFORMITY

The  CE  conformity  marking  shall  consist  of  the  initials  ‘CE’  taking  the  following  form:

—  If  the  marking  is  reduced  or  enlarged  the  proportions  given  in  the  above  graduated  drawing  must  be

respected,

—  the  various  components  of  the  CE  marking  must  have  substantially  the  same  vertical  dimension,  which

may  not  be  less  than  5 mm.  This  minimum  dimension  may  be  waived  for  small-scale  devices.