PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES
Date: 1991-08-23
Institutions: European Commission
Subjects: harmonisation of standards, medical device, occupational safety, public health, radiation protection, radiobiology

COMMISSION OF THE EUROPEAN  COMMUNITIES 

C0MC91) 287 final  - SYN  353 

Brussels,  23 August  1991 

Proposal  for a 

COUNCIL  DIRECTIVE 

concerning medical  devices 

(presented  by  the Commission) 

2 -

EXPLANATORY  MEMORANDUM 

I.  GENERAL  FRAMEWORK 

This  proposal  for  a  directive  has  been  prepared  in  the 
context  of  the  White  Paper  on  completing  the  internal 
m a r k e t,  the  work  programme  of  which  provides  for 
harmonization  of  the  laws  relating  to  electro-medical 
equ i pment . 

In  this  c o n t e x t,  the  Council  adopted  a  first  directive 
relating  to  active  implantable  medical  devices 
(Directive  9 0 / 3 8 5 / E E C)  on  20  June  1990.  With  the  adoption 
of  this  d i r e c t i v e,  a  preponderant  part  of  the  field  of 
medical  devices  will  be  covered  by  harmonized  laws. 
H o w e v e r,  medical  devices  intended  for 
not  included  in  the  scope  of  this  proposal.  These  products 
will  be  dealt  w i t h,  in  view  of  their  particular  n a t u r e,  in  a 
spec ific  d i e c t i v e. 

diagnosis  are 

in  vitro 

Before  starting  on  the  preparation  of  its  p r o p o s a l,  the 
Commission  examined  the  regulations  relating  to  the  medical 
devices  sector.  The  results  of  this  examination  confirmed 
that  there  are  considerable  differences  between  the  Member 
States  as  regards  both  the  technical  design  and  production 
requirements  and  the  administrative  procedures  for  the 
e x a m i n a t i o n,  testing,  inspection  and  authorization  for 
m a r k e t i n g,  and  the  putting  into  service  and  after-sales 
surveillance  of  medical  devices. 

The  current  legislative  situation  in  the  Member  States  is 
characterized  by  a  marked  lack  of  uniformity  if  the  various 
national  laws  are  compared  with  regard  to  their  scope  and 
the  kind  of  risks  covered.  A  large  number  of  specific  laws 
cover  certain  groups  of  products  such  as  electro-medical 
e q u i p m e n t,  disposable  p r o d u c t s,  equipment  for  the  disabled, 
sterile  p r o d u c t s,  and  even  specific  p r o d u c t s.  In  several 
Member  S t a t e s,  a  range  of  medical  devices  (in  particular  in 
the  field  of  sterile  and  disposable  products)  are  covered, 
in  the  absence  of  specific  laws,  by  the  regulations  on 
medicinal  p r o d u c t s.  The  fact  that  medical  e q u i p m e n t,  which 
as  a  general  rule  acts  physically,  is  sometimes  treated  the 
same  as  medicinal  p r o d u c t s,  which  act  p h a r m a c o l o g i c a l l y,  has 
led  in  several  cases  to  technical  b a r r i e r s. 

-  3  -

W i th  t he  r e g a rd  to  the  m e a ns  of  .control  u s ed  to  e n s u re  the 
s a f e ty  a nd  h e a l th  p r o t e c t i on  of  p a t i e n ts  a nd  u s e r s,  t wo 
d i f f e r e nt  a p p r o a c h es  w e re  f o u nd  in  the  C o m m u n i t y.  A  l a r ge 
n u m b er  of  t he  M e m b er  S t a t es  a p p ly  s y s t e ms  b a s ed  on  t he 
i n s p e c t i on  of  p r o d u c ts  b e f o re  t h ey  a re  p l a c ed  on  t he  m a r k et 
by  m e a ns  of  t y p e - e x a m i n a t i o ns  or  a p p r o v al  s y s t e m s,  w h i le 
o t h e rs  a sk  c o m p a n i es  to  a p p ly  g o od  m a n u f a c t u r i ng  p r a c t i c e s. 
W h e re  t he  d e v i c es  a re  s u b j e ct  to  the  r u l es  on  m e d i c i n al 
p r o d u c t s,  b o th  p r o d u ct  c e r t i f i c a t i on  and  a u t h o r i z a t i on 
p r o c e d u r es  for  c o m p a n i es  a p p l y. 

T he  i n f o r m a t i on  o b t a i n ed  p u r s u a nt  to  D i r e c t i ve  8 3 / 1 8 9 / E EC 
l a y i ng  d o wn  an  i n f o r m a t i on  p r o c e d u re  in  the  f i e ld  of 
t e c h n i c al  r e g u l a t i o ns  c o n f i r ms  the  lack  of  u n i f o r m i ty  in  the 
l e g i s l a t i ve  a p p r o a ch  t a k en  w i th  r e g a rd  to  m e d i c al  d e v i c e s. 
B e t w e en  1 9 88  and  1 9 9 0,  s o me  25  s e ts  of  d r a ft  n a t i o n al 
r e g u l a t i o n s,  m o st  of  t h em  r e l a t i ng  to  s p e c i f ic  p r o d u c t s, 
w e re  n o t i f i ed  to  the  C o m m i s s i o n. 

L a s t l y,  it  s h o u ld  be  s a id  that  s o me  of  the  M e m b er  S t a t es  a re 
a w a re  of  t he  u n s a t i s f a c t o ry  s i t u a t i on  and  h a ve  i n d i c a t ed 
t h e ir  d e s i re  to  e s t a b l i sh  an  o v e r a ll  legal  f r a m e w o rk  for  the 
m e d i c al  d e v i c es  f i e l d. 

In  v i ew  of  t he  d i f f e r e n c es  in  a p p r o a c h,  w h i ch  by  t h e ir 
n a t u re  a re  i n c o m p a t i b le  w i th  a  s i n g le  C o m m u n i ty  m a r k et  in 
m e d i c al  d e v i c e s,  it  is  e s s e n t i al  to  set  up  a  C o m m u n i ty 
s y s t em  of  laws  b a s ed  on  A r t i c le  100a  of  the  E EC  T r e a ty  to 
a b o l i sh  a nd  p r e v e nt  t e c h n i c al  b a r r i e rs  to  t r a d e. 

T he  a im  of  t h is  d i r e c t i v e,  t h e r e f o r e,  is  to  e n s u re  t he 
s a f e ty  a nd  h e a l th  p r o t e c t i on  of  p a t i e n ts  a nd  u s e rs  by  m e a ns 
of  a  u n i f o rm  s e c t o r al  a p p r o a ch  and  to  c r e a te  an  a p p r o p r i a t e, 
s u i t a b le  f r a m e w o rk  for  the  t e c h n o l o g i c al  d e v e l o p m e nt  of  the 
p r o d u c ts  c o n c e r n e d. 

T he  m e d i c al  d e v i c es  s e c t or  is  a  large  m a r k e t:  w o r ld 
c o n s u m p t i on  of  t h e se  p r o d u c ts  in  1 9 90  h as  b e en  put  at 
ECU  5 4 .1  b i l l i o n,  i n c l u d i ng  ECU  23.1  b i l l i on  in  t he  U SA  a(1 
ECU  -  1.2  U S $)  and  ECU  1 5 .0  b i l l i on  in  the  C o m m u n i ty 
( s o u r c e:  H e a l th  I n d u s t ry  M a n u f a c t u r e rs  A s s o c i a t i on 
( H I M A ) ). 
T he  C o m m u n i ty  s h a re  of  w o r ld  p r o d u c t i on  h as  b e en  c a l c u l a t ed 
to  be  E CU  16.1  b i l l i on  ( U S A:  2 5 .7  -  J a p a n:  8 . 0 ).  B e t w e en 
1 9 86  a nd  1 9 8 9,  the  a n n u al  a v e r a ge  g r o w th  in  c o n s u m p t i on  w as 
9 . 5%  ( U S A:  9 . 9%  -  J a p a n:  8 . 6 % ).  T he  n u m b er  of  J o bs  in  t h is 
b r a n ch  of  i n d u s t ry  w i t h in  the  C o m m u n i ty  t o t a l l ed  o v er 
2 00  0 00  in  1 9 9 0. 

-  A  -

In  v i ew  of  t he  r a p id  s p e ed  of  i n n o v a t i on  in  t h is  s e c t o r, 
C o m m u n i ty  l e g i s l a t i on  w i ll  p r o v i de  an  a p p r o p r i a te  f r a m e w o rk 
w h i ch  w i ll  h e lp  to  m a i n t a in  a nd  to  p r o m o te  t h is  f a v o u r a b le 
d e ve I o p m e n t. 

T he  p r o p o s al  for  a  d i r e c t i ve  h as  b e en  d e s i g n ed  a nd 
s t r u c t u r e d,  as  r e g a r ds  t e c h n i c al  r e q u i r e m e n t s,  in  t he  light 
of  t he  C o u n c il  R e s o l u t i on  of  7  M ay  1 9 85  on  a  n ew  a p p r o a ch  to 
t e c h n i c al  h a r m o n i z a t i on  a nd  s t a n d a r d i z a t i on 
l e g i s l a t o rs  a l r e a dy  a p p l i ed  t he  p r i n c i p l es  s et  o ut  in  t he 
R e s o l u t i on  w i th  t he  a d o p t i on  of  C o u n c il 
a b o v e m e n t i o n ed 
D i r e c t i ve  9 0 / 3 8 5 / E EC  of  20  J u ne  1 9 90  r e l a t i ng  to  a c t i ve 
i m p l a n t a b le  m e d i c al  d e v i c es 
i n c l u d es  w h at  h as  b e en  a c h i e v ed  w i th  t h at  D i r e c t i ve  a nd 
t r a n s p o s es  it  to  t he  m e d i c al  d e v i c es  w h i ch  it  c o v e r s. 

T h is  p r o p o s al  t h e r e f o re 

T he 

T he  i m p l e m e n t a t i on  of  t he  c o n c e pt  of  r e f e r e n ce  to  s t a n d a r ds 
w i ll  be  f a c i l i t a t ed  by  t he  f a ct  t h at  s o me  of  t he  h a r m o n i z ed 
E u r o p e an  s t a n d a r d s,  in  p a r t i c u l ar  t h o se  of  a  h o r i z o n t al 
n a t u r e,  w i ll  a l r e a dy  be  a v a i l a b le  f r om  t he  a p p l i c a t i on  of 
t he  D i r e c t i ve  r e l a t i ng  to  a c t i ve  i m p l a n t a b le  m e d i c al 
d e v i c e s.  F u r t h e r m o r e,  i m p o r t a nt  w o rk  on  t he  e s t a b l i s h m e nt  of 
a  s e c t o r al  s y s t em  of  h a r m o n i z ed  s t a n d a r ds  h as  a l r e a dy  b e en 
s t a r t ed  by  C E N / C E N E L E C. 

T he  p a rt  of  t he  d i r e c t i ve  r e l a t i ng  to  p r o c e d u r es  for  t he 
a s s e s s m e nt  of  c o n f o r m i ty  is  b a s ed  on  t he  m o d u l ar  a p p r o a ch 
set  o ut  in  C o u n c il  D e c i s i on  9 0 / 6 8 3 / E EC  of  13  D e c e m b er  1 9 90 

T he  a p p r o a ch  f o l l o w ed  w i th  r e g a rd  to  t he  a s s e s s m e nt  of 
c o n f o r m i ty  e n a b l es  a  d i s t i n e t i on  to  be  m a de  w i th  r e g a rd  to 
v e r i f i c a t i o ns  c a r r i ed  o ut  by  a  t h i rd  p a r ty  a c c o r d i ng  to  t he 
n a t u re  of  t he  p o t e n t i al  r i sk  i n h e r e nt  in  m e d i c al  d e v i c e s. 
For  t h is  r e a s on  a nd  in  v i ew  of  the  d i v e r s i ty  of  p r o d u c ts 
c o n c e r n e d,  t he  d e v i c es  c o v e r ed  by  t he  d i r e c t i ve  h a ve  b e en 
d i v i d ed  i n to  f o ur  c l a s s es  for  the  p u r p o se  of  a s s e s s m e nt 
p r o c e d u r es . 

T he  i n t e r v e n t i on  of  t he  c e r t i f i c a t i on  b o d i es  ( n o t i f i ed 
b o d i e s)  h as  b e en  g r a d e d.  For  d e v i c es  in  C l a ss  I,  c o n f o r m i ty 
is  e s t a b l i s h ed  as  a  g e n e r al  r u le  u n d er  t he  r e s p o n s i b i l i ty 
of  t he  m a n u f a c t u r er  a l o n e.  C l a ss  Ma  d e v i c es  r e q u i r e,  in 
v i ew  of  t he  r i s ks  m o re  c l o s e ly  a s s o c i a t ed  w i th  m a n u f a c t u r e, 
t he  i n t e r v e n t i on  of  a  n o t i f i ed  b o dy  w i th  r e g a rd  to  t he 
m a n u f a c t u re  s t a g e. 
t he  o t h er  h a n d,  v e r i f i c a t i on  by  a  n o t i f i ed  b o dy  is 
n e c e s s a ry  w i th  r e g a rd  to  d e s i gn  a nd  t he  m a n u f a c t u r i ng 
s t a g e.  F u r t h e r m o r e,  C l a ss  III  d e v i c es  w h i ch  a re  c r i t i c al 
d e v i c es  s h o u l d,  as  a  g e n e r al  r u l e,  u n d e r go  a  c l i n i c al 
e v a l u a t i on  u n d er  t he  r e s p o n s i b i l i ty  of  t he  m a n u f a c t u r e r. 
T he  c o n f o r m i ty  of  t h e ir  d e s i gn  m u st  be  e x p l i c i t ly  c e r t i f i ed 
by  a  n o t i f i ed  b o dy  b e f o re  t h ey  a re  p l a c ed  on  t he  m a r k e t. 

For  d e v i c es  in  C l a s s es  Mb  a nd  I I I,  on 

OJ  No  C  1 3 6, 
OJ  He  L  1 89 , 

CD 
ic) 
(3)  OJ  No  L  3 80 

4 . 6 . 1 9 8 5,  p.  1 . 
2 C . 7. i 9 9 0,  p.  1 7. 
3 1 . 1 2. 1 9 9 0,  p 

13 

I I .  C O N T E N TS  OF  T HE  P R O P O S AL 

1 • 

A r t i c le  1  -  S c o pe 

S e v e r al  d e f i n i t i o n s,  in  p a r t i c u l ar  t h o se  of  a  " m e d i c al 
d e v i c e ",  a  " c u s t o m - m a de  d e v i c e"  a nd  a  " d e v i ce  i n t e n d ed  for 
c l i n i c al  i n v e s t i g a t i o n"  h a ve  b e en  t a k en  f r om  t he  D i r e c t i ve 
r e l a t i ng  to  a c t i ve  i m p l a n t a b le  m e d i c al  d e v i c e s.  S i n ce  t he 
s c o pe  of  t h is  p r o p o s al  is  b r o a d er  t h an  that  of  t he 
a b o v e m e n t i o n ed  D i r e c t i v e,  a  few  s l i g ht  a m e n d m e n ts  h a ve 
t h e r e f o re  b e en  m a d e. 

T he  t e rm  " m e d i c al  d e v i c e"  m e a ns  p r o d u c ts  t he  f u n c t i on  of 
w h i ch  is  s o l e ly  or  p r i n c i p a l ly  m e d i c a l.  A  s e r i es  of  p r o d u c ts 
w h o se  f u n c t i on  is  not  e s s e n t i a l ly  m e d i c al  a re  t h e r e f o re 
e x c l u d ed  f r om  t he  s c o p e,  e v en  if  t h e se  p r o d u c ts  m ay  be  u s ed 
to  p r e v e nt  d i s e a se  or  a l l e v i a te  a  h a n d i c a p,  e . g.  c o s m e t ic 
p r o d u c t s,  m u l t i p l e - u se  d a t a - p r o c e s s i ng  e q u i p m e n t. 

T he  m e d i c al  f u n c t i on  of  a  m e d i c al  d e v i ce  m ay  be  f u l f i l l ed 
e i t h er  by  m e a ns  of  a  p r o d u ct  u s ed  on  its  o wn  or  as  t he 
r e s u lt  of  t he  c o m b i n a t i on  of  s e v e r al  p r o d u c t s,  e . g. 
d i s p o s a b le  t u b i n gs  c o m b i n ed  w i th  an  i n f u s i on  p u m p. 

T he  c r i t e r i on  for  t he  d i s t i n c t i on  b e t w e en  a  m e d i c al  d e v i ce 
a nd  a  m e d i c i n al  p r o d u ct  is  the  p r i n c i p al  a c t i on  p r o d u c e d.  A 
p r o d u ct  w h i ch  a c h i e v es  its  p r i n c i p al  a c t i on  by 
p h a r m a c o l o g i c a l,  i m m u n o l o g i c al  or  m e t a b o l ic  m e a ns  is  not 
c o n s i d e r ed  to  be  a  m e d i c al  d e v i c e.  H o w e v e r,  a  m e d i c al  d e v i ce 
m ay  i n c l u de  a  m e d i c i n al  s u b s t a n ce  as  an  i n t e g r al  p a rt  in 
o r d er  to  i n c r e a se  its  e f f e c t i v e n e s s,  e . g.  a  h e p a r i n - c o a t ed 
c a t h e t er . 

W h e re  t he  a c t i on  p r o d u c ed  by  the  p r e s e n ce  of  t he  m e d i c i n al 
s u b s t a n ce  is  s e c o n d a ry  to  the  p r i n c i p al  a c t i on  of  t he 
d e v i c e,  t he  c o n f o r m i ty  a s s e s s m e nt  p r o c e d u re  for  a u t h o r i z i ng 
t he  p l a c i ng  of  t he  p r o d u ct  c o n c e r n ed  on  t he  m a r k et  is 
c o v e r ed  by  t h is  p r o p o s al  for  a  d i r e c t i v e.  As  far  as  s a f e ty 
a s p e c ts  c o n c e r n i ng  the  p r e s e n ce  of  the  s u b s t a n ce  a re 
c o n c e r n e d,  t he  v e r i f i c a t i o ns  r e q u i r ed  a re  c a r r i ed  o u t,  w h e re 
a p p r o p r i a t e,  by  a n a l o gy  to  the  m e t h o ds  c o n t a i n ed  in 
D i rect i ve  7 5 / 3 1 8 / E E C. 

-  6  -

On  t he  o t h er  h a n d,  w h e re  a  d e v i ce  is  i n t e n d ed  to  a d m i n i s t er 
a  m e d i c i n al  p r o d u ct  a nd  t h e r e f o re  c o n s t i t u t es  a  c o n t a i n er 
for  t h at  p r o d u c t,  e . g.  a  p r e - f i l l ed  s y r i n g e,  t he  a s p e c ts 
r e l a t i ng  to  t he  s a f e ty  of  t he  d e v i ce  a re  c o v e r ed  by  t h is 
p r o p o s a l,  w h i le  t he  p l a c i ng  of  the  m e d i c i n al  p r o d u ct  on  t he 
m a r k et  is  s u b j e ct  to  t he  C o m m u n i ty  l e g i s l a t i on  r e l a t i ng  to 
m e d i c i n al  p r o d u c ts  ( s ee  A r t i c le  1,  p a r a.  3 ). 

T he  k ey  legal  d e f i n i t i o ns  i n c l u de  d e f i n i t i o ns  of  " p l a c i ng  on 
t he  m a r k e t"  a nd  t he  " m a n u f a c t u r e r ".  T he  " p l a c i ng  on  t he 
m a r k e t"  m e a ns  t he  p h y s i c al  t r a n s f er  of  a  m e d i c al  d e v i ce  f r om 
t he  m a n u f a c t u r er  or  a  p e r s on  a u t h o r i z ed  by  h im  to  t he 
d i s t r i b u t or  or  u s e r.  P l a c i ng  on  the  m a r k et  m u st  not  be 
c o n f u s ed  w i th  t he  r i g h t,  u n d er  the  d i r e c t i v e,  to  m a r k et 
m e d i c al  d e v i c es  in  the  E u r o p e an  C o m m u n i t y.  T he  d e f i n i t i on  of 
t he  m a n u f a c t u r er  is  u s e f ul  in  o r d er  to  be  a b le  to  d e t e r m i ne 
t he  n a t u r al  or  legal  p e r s o ns  s u b j e ct  in  p a r t i c u l ar  to  t he 
c o n f o r m i ty  a s s e s s m e nt  p r o c e d u r es  ( A r t i c le  1 0 ). 

T he  s c o pe  of  t h is  p r o p o s al  i n c l u d es  m e d i c al  d e v i c es  w h i ch 
e m it  i o n i z i ng  r a d i a t i o n.  It  t h e r e f o re  s p e c i f i es  t he 
r e q u i r e m e n ts  r e l a t i ng  to  the  d e s i gn  and  m a n u f a c t u re  of  t he 
e q u i p m e nt  c o n c e r n ed  a nd  t he  c o n f o r m i ty  a s s e s s m e nt 
p r o c e d u r e s.  T he  d i r e c t i ve  d o es  n o t,  h o w e v e r,  a f f e ct  t he 
a u t h o r i z a t i on  r e q u i r ed  u n d er  D i r e c t i ve  8 0 / 8 3 6 / E u r a t om  for 
t he  p u t t i ng  into  s e r v i ce  a nd  u se  of  s u ch  e q u i p m e n t. 

A r t i c l es  2  a nd  3 

T h e se  a re  c o n v e n t i o n al  A r t i c l es  b a s ed  on  t he  n ew  a p p r o a ch 
r e l a t i ng  to  p l a c i ng  on  the  m a r k e t,  p u t t i ng  into  s e r v i ce  and 
e s s e n t i al  r e q u i r e m e n t s. 

A r t i c le  4  -  F r ee  m o v e m e n t,  d e v i c es  i n t e n d ed  for  s p e c i al 
p u r p o s es 

In  a d d i t i on  to  t he  c o n v e n t i o n al  c l a u se  c o n c e r n i ng  f r ee 
m o v e m e n t,  t h is  A r t i c le  r e f e rs  to  d e v i c es  i n t e n d ed  for 
s p e c i al  p u r p o s e s,  i.e.  d e v i c es  i n t e n d ed  for  c l i n i c al 
i n v e s t i g a t i on  a nd  c u s t o m - m a de  d e v i c e s. 

D e v i c es  i n t e n d ed  for  c l i n i c al  i n v e s t i g a t i on  a re  m a de 
a v a i l a b le  to  m e d i c al  p r a c t i t i o n e rs  w h en  t o t al  c o m p l i a n ce 
w i th  t he  e s s e n t i al  r e q u i r e m e n ts  s t i ll  h as  to  be  e s t a b l i s h ed 
so  t h at  t he  d e v i ce  c an  u n d e r go  an  a s s e s s m e nt  of  c o n f o r m i ty 
p r o c e d u r e.  T he  c a r r y i ng  o ut  of  c l i n i c al 
s p e c i f i c a l ly  m a k es  it  p o s s i b le  to  c o n f i rm  c o n f o r m i ty  w i th 
t he  r e l e v a nt  e s s e n t i al  r e q u i r e m e n t s. 
do  not  b e ar  t he  CE  m a r k. 

i n v e s t i g a t i o ns 

S u ch  d e v i c es  t h e r e f o re 

-  7  -

C u s t o m - m a de  d e v i c es  a re  m a de  in  a c c o r d a n ce  w i th  t he 
p r e s c r i p t i on  of  a  m e d i c al  s p e c i a l i st  or  a ny  o t h er  a u t h o r i z ed 
p e r s on  g i v i ng  t he  s p e c i f ic  d e s i gn  c h a r a c t e r i s t i cs  of  t he 
d e v i ce  c o n c e r n e d.  C o m p l i a n ce  w i th  the  r e q u i r e m e n ts  of  t he 
d i r e c t i ve  is  t h e r e f o re  e s t a b l i s h ed  u n d er  t he  J o i nt 
r e s p o n s i b i l i ty  of  t he  m a n u f a c t u r er  a nd  t he  p e r s on  i s s u i ng 
t he  p r e s c r i p t i on  a nd  t h is  is  w hy  s u ch  d e v i c es  do  not  h a ve  to 
b e ar  t he  CE  m a r k. 

A r t i c le  5  -  R e f e r e n ce  to  s t a n d a r ds 

T he  r e f e r e n ce  to  h a r m o n i z ed  s t a n d a r ds  c l a u se  is  b a s ed  on  t he 
C o u n c il  R e s o l u t i on  of  7  M ay  1 9 8 5. 

By  m e a ns  of  t he  r e f e r e n ce  to  c e r t a in  m o n o g r a p hs  of  t he 
E u r o p e an  P h a r m a c o p o e ia  in  p a r a g r a ph  2,  t he  C o m m u n i ty  is 
d i s c h a r g i ng  t he  o b l i g a t i o ns  i n c u m b e nt  on  t he  M e m b er  S t a t es 
p u r s u a nt  to  t he  C o n v e n t i on  of  22  J u ly  1 9 64  on  t he 
p r e p a r a t i on  of  a  E u r o p e an  P h a r m a c o p o e i a. 

In  t he  f i e ld  of  t he  m e d i c al  d e v i c es  c o v e r ed  by  t h is 
p r o p o s a l,  t he  E u r o p e an  P h a r m a c o p o e ia  h as  p r e p a r ed  s e v e r al 
m o n o g r a p hs  r e l a t i ng  in  p a r t i c u l ar  to  s u t u r es  a nd  t he 
i n t e r a c t i on  b e t w e en  c e r t a in  m a t e r i a ls  u s ed  for  d e v i c es  a nd 
m e d i c i n al  p r o d u c t s.  S u b j e ct  to  A r t i c le  5,  p a r a g r a ph  2,  t h e se 
m o n o g r a p hs  w i ll  h a ve  t he  s a me  s t a t u s,  u n d er  t h is  p r o p o s a l, 
as  h a r m o n i z ed  s t a n d a r d s.  T he  a p p l i c a t i on  of  t he  m o n o g r a p hs 
w i ll  t h e r e f o re  r e m a in  v o l u n t a r y. 

T he  C o m m i s s i on  h as  p r o p o s ed  to  the  C EN  a nd  t he  E u r o p e an 
P h a r m a c o p o e ia  t he  c o n c l u s i on  of  a  m e m o r a n d um  of 
u n d e r s t a n d i ng  to  d e t e r m i ne  the  r e s p e c t i ve  f i e l ds  of  a c t i v i ty 
and  to  e s t a b l i sh  c o l l a b o r a t i on  in  a r e as  of  c o m m on  i n t e r e s t. 

A r t i c l es  6  a nd  7. -  C o mm i t t e es 

R e g a r d l e ss  of  t he  c o n v e n t i o n al  r o le  of  t he  C o m m i t t ee  set  up 
u n d er  D i r e c t i ve  8 3 / 1 8 9 / E EC  ( c f.  A r t i c le  5 ( 3 ) ),  t he  f i e ld  of 
a c t i v i ty  of  t he  A d v i s o ry  C o m m i t t ee  set  up  u n d er  D i r e c t i ve 
9 0 / 3 8 5 / E EC  h as  b e en  e x t e n d ed  to  the  s e c t or  c o v e r ed  by  t he 
p r o p o s a l.  A ny  m a t t er  r e l a t i ng  to  the  i m p l e m e n t a t i on  a nd 
p r a c t i c al  a p p l i c a t i on  of  t he  D i r e c t i ve  m ay  be  b r o u g ht  b e f o re 
t h is  C o mm i 1 1 e e. 

-  8  -

W i th  r e g a rd  to  t he  c l a s s i f i c a t i on  of  m e d i c al  d e v i c es  into 
f o ur  c l a s s es  of  p r o d u c ts  ( s ee  A r t i c l es  8  a nd  1 2 ),  r e g u l a t o ry 
m e a s u r es  h a ve  to  be  laid  d o wn  at  C o m m u n i ty  level  for  t he 
p r o d u c ts  c o n c e r n e d.  In  v i ew  of  the  n a t u re  of  t h e se  m e a s u r es 
a nd  t he  c o n s e q u e n c es  as  r e g a r ds  the  level  of  i n t e r v e n t i on  of 
t h i rd  p a r t i e s,  t he  m e a s u r es  s h o u ld  be  a d o p t ed  in  a c c o r d a n ce 
w i th  t he  " R e g u l a t o ry  C o m m i t t e e"  p r o c e d u re  ( v a r i a nt  Ilia  of 
C o u n c il  D e c i s i on  8 7 / 3 7 3 / E EC  of  13  J u ly  1 9 87  l a y i ng  d o wn  the 
p r o c e d u r es  for  t he  e x e r c i se  of  i m p l e m e n t i ng  p o w e rs  c o n f e r r ed 
on  t he  C o m m i s s i o n ). 

A r t i c le  8-  S a f e g u a rd  c l a u se 

T h is  A r t i c le  is  b a s ed  on  the  C o u n c il  R e so 
7  M ay  1 9 85  c o n c e r n i ng  the  n ew  a p p r o a c h. 

ut i on  of 

A r t i c l es  9  a nd  13  -  C l a s s i f i c a t i on 

M e d i c al  d e v . c es  a re  d i v i d ed  into  f o ur  p r o d u ct  c l a s s es  in 
o r d er  to  be  a b le  to  d e c i de  on  the  a p p r o p r i a te  level  of 
i n t e r v e n t i on  by  t he  n o t i f i ed  b o d i e s.  T he  c l a s s i f i c a t i on 
r u l es  set  o ut  in  A n n ex  9  e n a b le  m a n u f a c t u r e rs  to  c l a s s i fy 
t h e ir  p r o d u c ts  a c c o r d i ng  to  the  r e l e v a nt  c l a s s.  W h e re  t h e re 
is  d o u b t,  m a n u f a c t u r e rs  m ay  c o n t a ct  the  c o m p e t e nt 
a u t h o r i t i es  w h i c h,  for  t h e ir  p a r t,  m a y,  if  n e c e s s a r y, 
i n i t i a te  t he  C o m m u n i ty  d e c i s i o n - m a k i ng  p r o c e s s. 

D e c i s i o ns  m ay  h a ve  to  be  t a k en  w i th  r e g a rd  to  t he 
c l a s s i f i c a t i on  of  m e d i c al  d e v i c es  in  p a r t i c u l ar  w h e r e: 

t he  c l a s s i f i c a t i on  r u l es  and  the  C o m m i s s i on  g u i d e l i n es  do 
not  e n a b le  a  s t r a i g h t f o r w a rd  c l a s s i f i c a t i on  to  be  made-, 

t he  e x p e r i e n ce  o b t a i n ed  w i th  s p e c i f ic  f a m i l i es  of 
p r o d u c ts  j u s t i f i es  a  r e c l a s s i f i c a t i on  by  w ay  of 
d e r o g a t i on  f r om  the  c l a s s i f i c a t i on  r u l e s; 

t he  c l a s s i f i c a t i on  r u l es  n e ed  to  be  a d j u s t ed  in  t he  light 
of  t e c h n i c al  d e v e l o p m e nt  a n d / or  e x p e r i e n ce  w i th  g i v en 
d ev i c es . 

-  9  -

A r t i c le  10  -  I n f o r m a t i on  on  i n c i d e n ts  o c c u r r i ng  f o l l o w i ng 
p l a c i ng  of  d e v i c es  on  t he  m a r k et 

T h is  A r t i c le  s e ts  up  a  C o m m u n i ty  w a r n i ng  s y s t em  r e g a r d i ng 
i n c i d e n ts  o c c u r r i ng  w i th  d e v i c es  a l r e a dy  p l a c ed  on  t he 
m a r k e t.  T h is  s y s t em  w i ll  e n a b le  t he  M e m b er  S t a t es  to  t a ke 
a p p r o p r i a te  m e a s u r es  e a r ly  on  w h e re  an  i n c i d e nt  s u g g e s ts 
t h a t,  b e c a u se  of  a  d e s i gn  or  m a n u f a c t u r i ng  f a u l t,  a  d e v i ce 
m ay  s e r i o u s ly  d a m a ge  t he  h e a l th  of  p a t i e n ts  or  u s e r s. 

T he  o b l i g a t i o ns  on  m a n u f a c t u r e rs  to  n o t i fy  c e r t a in  i n c i d e n ts 
a re  set  o ut  in  A n n ex  2,  p o i nt  3 . 1,  A n n ex  4,  p o i nt  3,  A n n ex 
5,  p o i nt  3 . 1,  a nd  A n n ex  6,  p o i nt  3 . 1.  E a ch  M e m b er  S t a te  m u st 
set  up  a  c e n t r al  u n it  to  r e c o rd  and  e v a l u a te  t he  r e p o r ts 
o b t a i n e d.  W h e re  m e a s u r es  h a ve  to  be  t a k en  by  t he  n a t i o n al 
a u t h o r i t i e s,  t he  M e m b er  S t a te  c o n c e r n ed  m u st  i n f o rm  t he 
o t h er  M e m b er  S t a t es  a nd  the  C o m m i s s i o n. 

A r t i c le  1 1r  A n n e x es  2  to  7  -  C o n f o r m i ty  a s s e s s m e nt 
p r o c e d u r es 

S u i t a b le  c o n f o r m i ty  a s s e s s m e nt  p r o c e d u r es  h a ve  b e en  s e l e c t ed 
f r om  a m o ng  t h o se  a d o p t ed  in  C o u n c il  D e c i s i on  9 0 / 6 8 3 / E EC  of 
13  D e c e m b er  1 9 90  a nd  s u p p l e m e n t ed  a c c o r d i ng  to  s e c t o r al 
r e q u i r e m e n t s. 
to  t he  d o c u m e n t a t i on  r e q u i r e d,  the  s a f e ty  of  c o m b i n ed 
d e v i c e s,  s t e r i l i z a t i on  p r o c e d u r es  and  c l i n i c al  d a t a.  T he 
f o l l o w i ng  p r o c e d u r es  a p p ly  to  the  four  c l a s s es  of  d e v i c e s: 

T he  m i n or  a d d i t i o ns  m a de  r e f er  in  p a r t i c u l ar 

C I a ss  I 

t he  m a n u f a c t u r er  a l o ne  is  r e s p o n s i b le  for  the 
a s s e s s m e nt  of  c o n f o r m i ty  ( m o d u le  A  of  C o u n c il 
D e c i s i on  9 0 / 6 8 3 / E E C) 

C I a ss  I I a  t he  m a n u f a c t u r er  h i m s e lf  is  r e s p o n s i b le  for 

a s s e s s i ng  the  p r o d u ct  d e s i g n.  T he 
i n t e r v e n t i on  of  a  n o t i f i ed  b o dy  is  r e q u i r ed 
at  t he  p r o d u c t i on  s t a ge  ( m o d u le  A  c o m b i n ed 
w i th  e i t h er  m o d u l es  D,  E  or  F ).  F u r t h e r m o r e, 
t he  m a n u f a c t u r er  m ay  opt  for  full  q u a l i ty 
a s s u r a n ce  ( m o d u le  H ),  a l t h o u gh  t he  p r o c e d u re 
s p e c i f i ed  in  that  m o d u le  is  m o re  r e s t r i c t i ve 
t h an  t h o se  m e n t i o n ed  a b o v e. 

-  10  -

C I a ss  I I b 

- 

C l a ss  I I I 

t he  d e s i gn  and  m a n u f a c t u re  of  t he  p r o d u ct 
m u st  be  r e f e r r ed  to  a  n o t i f i ed  b o d y.  T he 
m a n u f a c t u r er  m ay  f o l l ow  e i t h er  t he  full 
q u a l i ty  a s s u r a n ce  p r o c e d u re  ( m o d u le  H)  or 
s u b m it  a  p r o t o t y pe  for  t y p e - e x a m i n a t i on 
( m o d u le  B ).  In  the  c a se  of  t he  l a t t e r,  t he 
m a n u f a c t u r er  m u st  a l so  a p p ly  o ne  of  t he 
p r o c e d u r es  r e f e r r ed  to  in  m o d u l es  D,  E  or  F 

t he  p r o c e d u r es  a re  b r o a d ly  t he  s a me  as  t h o se 
set  out  for  C l a ss  M b.  H o w e v e r,  if  full 
q u a l i ty  a s s u r a n ce  is  a p p l i ed  ( m o d u le  H)  t he 
f i le  r e l a t i ng  to  the  p r o d u ct  d e s i gn  m u st  be 
e x a m i n e d.  F u r t h e r m o r e,  r e g a r d l e ss  of  t he 
p r o c e d u re  f o l l o w ed  the  d e s i gn  f i le  m u st  as  a 
g e n e r al  r u le  i n c l u de  an  a s s e s s m e nt  of 
c o n f o r m i ty  b a s ed  on  c l i n i c al  d a ta  ( s ee 
A n n ex  1 0,  po i nt  1 . 1 ). 

T he  m a n u f a c t u r e r s'  c h o i ce  of  s e v e r al  p r o c e d u r es  w i ll  m a ke  it 
p o s s i b le  to  s e l e ct  the  m o st  a p p r o p r i a te  p r o c e d u re  t a k i ng 
a c c o u nt  in  p a r t i c u l ar  of  the  p r e - e x i s t i ng  r e g u l a t o ry  s y s t em 
a nd  t he  n a t u re  and  s i ze  of  the  c o m p a n y. 

10 

A r t i c le  12  -  A s s e m b ly  and  s t e r i l i z a t i on 

T h is  A r t i c le  r e f e rs  to  a s s e m b ly  and  s t e r i l i z a t i on  a c t i v i t i es 
c a r r i ed  o ut  c o m m e r c i a l l y.  It  a p p l i es  to  d e v i c es  a l r e a dy 
b e a r i ng  t he  CE  m a r k.  T he  p e r s on  w ho  c a r r i es  o ut  t he 
a c t i v i t i es  c o n c e r n ed  is  not  c o n s i d e r ed  to  be  the 
m a n u f a c t u r er  as  l e g a l ly  d e f i n ed  w h e re  t he  a c t i v i t i es  a re 
c a r r i ed  o ut  in  a c c o r d a n ce  w i th  the  m a n u f a c t u r e r 's 
i nst r u ct  i o n s. 

If,  h o w e v e r,  a s s e m b ly  and  s t e r i l i z a t i on  go  b e y o nd  the  l i m i ts 
laid  d o wn  by  t he  m a n u f a c t u r er  of  the  d e v i c e s,  t h ey  a re 
s p e c i f ic  m a n u f a c t u r i ng  a c t i v i t i es  w h i ch  a re  t h en  s u b j e ct  to 
t he  p r o c e d u r es  set  out  in  A r t i c le  1 0. 

T he  p r o c e d u r es  r e f e r r ed  to  in  A r t i c le  11  a p p ly  r e g a r d l e ss  of 
t he  c l a s s i f i c a t i on  of  the  d e v i c e. 

-  11  -

1 1• 

A r t i c le  14  -  R e g i s t r a t i on  of  p e r s o ns  r e s p o n s i b le  for  p l a c i ng 
d e v i c es  on  t he  m a r k et 

T h is  A r t i c le  a p p l i es  to  d e v i c es  w h i ch  a re  not  s u b j e ct  to 
i n s p e c t i on  by  a  n o t i f i ed  b o dy  b e f o re  b e i ng  p l a c ed  on  t he 
m a r k e t.  T h e se  a re  the  C l a ss  I  d e v i c es  and  c u s t o m - m a de 
d e v i c e s.  For  t h e se  d e v i c e s,  the  m a n u f a c t u r er  or  p e r s o n ( s) 
r e s p o n s i b le  for  p l a c i ng  t h em  on  the  m a r k et  m u st  I n f o rm  the 
c o m p e t e nt  a u t h o r i t i es  of  t he  a d d r e ss  of  t h e ir  r e g i s t e r ed 
p l a ce  of  b u s i n e ss  and  the  c a t e g o ry  of  d e v i c es  c o n c e r n e d. 
T h is  n o t i f i c a t i on  e n a b l es  the  M e m b er  S t a t es  to  h a ve  b e t t er 
c o n t r ol  of  t he  d e v i c es  in  q u e s t i on  w h i ch  a re  m a r k e t ed  in 
t h e ir  t e r r i t o ry  a n d,  if  n e c e s s a r y,  to  t a ke  a p p r o p r i a te 
m e a s u r es . 

12 

A r t i c le  15  -  C l i n i c al  i n v e s t i g a t i on 

C l i n i c al  i n v e s t i g a t i o ns  m ay  be  n e c e s s a ry  in  o r d er  to  c o n f i rm 
that  a  d e v i ce  f u l ly  c o m p l i es  w i th  the  e s s e n t i al 
r e q u i r e m e n t s.  T he  c o m p e t e nt  a u t h o r i t i es  of  e a ch  M e m b er  S t a te 
in  w h i ch  t he  i n v e s t i g a t i o ns  a re  c a r r i ed  o ut  m u st  be  a b le  to 
i n t e r v e n e,  if  n e c e s s a r y,  to  p r o t e ct  the  h e a l th  of  p a t i e n ts 
and  p u b l ic  o r d e r.  A r t i c le  1 4,  p a r a g r a ph  2,  lays  d o wn  a  t a c it 
a p p r o v al  p r o c e d u re  for  i m p l a n t a b le  and  o t h er  d e v i c es  in 
C l a ss  I I I. 

T he  r i g ht  of  i n t e r v e n t i on  of  the  c o m p e t e nt  a u t h o r i t i es  is 
c e n t r ed  on  c o n s i d e r a t i o ns  of  p u b l ic  h e a l th  a nd  p u b l ic  o r d e r. 
For  t h is  r e a s o n,  i n t e r v e n t i on  by  the  a u t h o r i t i es  d o es  not 
i n c l u de  a  p r e l i m i n a ry  e v a l u a t i on  of  o t h er  a s p e c ts  w h i ch  a re 
t he  s u b j e ct  of  the  c o n f o r m i ty  a s s e s s m e nt  p r o c e d u r e s.  T he 
r o le  of  an  e t h i cs  c o m m i t t ee  in  t h is  c o n t e xt  is  to  e v a l u a te 
t he  a c c e p t a b i l i ty  of  the  p l an  of  i n v e s t i g a t i o ns  f r om  t he 
v i e w p o i nt  of  p a t i e nt  h e a l th  and  e t h i c al  c o n s i d e r a t i o n s. 

T he  c o m p e t e nt  a u t h o r i t i es  a re  not  b o u nd  by  t he  o p i n i on 
e x p r e s s ed  by  an  e t h i cs  c o m m i t t e e.  H o w e v e r,  s u ch  an  o p i n i on 
m ay  m a ke  it  e a s i er  for  t h em  to  e x a m i ne  the  f i l e. 

1 3. 

A r t i c l es  16  to  19  -  N o t i f i ed  bodies,,  EC  m a rk 

T h e se  a re  A r t i c l es  t y p i c al  of  t he  new  a p p r o a ch  d i r e c t i v es 

-  12  -

1 4. 

A r t i c le  20  -  C o n f i d e n t i a l i ty 

T he  o b s e r v a n ce  of  c o n f i d e n t i a l i ty  is  e s s e n t i al  for  t he 
p r o t e c t i on  of  s p e c i f ic  d a ta  and  b e c a u se  of  t he  e c o n o m ic 
impact  of  t he  p r o c e d u r es  for  the  p a r t i es  c o n c e r n e d. 

1 5. 

A r t i c le  21  -  G u i d e l i n es 

T he  d o c u m e n ts  r e f e r r ed  to  in  the  g u i d e l i n es  a re  b a s ed  on  the 
p r a c t i ce  f o l l o w ed  w i th  r e g a rd  to  m e d i c i n al  p r o d u c ts  as  set 
o ut  in  D i r e c t i ve  8 9 / 3 4 1 / E E C. 
T he  g u i d e l i n es  m ay  p r o v i de 
u s e f ul  i n f o r m a t i on  for  the  a p p l i c a t i on  of  the  d i r e c t i v e, 
a l t h o u gh  t h ey  do  not  t h e m s e l v es  h a ve  a ny  legal  f o r c e.  T h ey 
w i ll  c o v er  a s p e c ts  that  a re  not  d e a lt  w i th  in  h a r m o n i z ed 
s t a n d a r d s. 

16 

A r t i c le  22  -  R e p e al  and  a m e n d m e nt  of  D i r e c t i v es 

D i r e c t i ve  7 6 / 7 6 4 / E EC  c o v e rs  mer cur y - i n - gI a ss  t h e r m o m e t e r s. 
It  is  an  o p t i o n al  D i r e c t i v e.  T he  p r o d u c ts  and  f e a t u r es 
c o n c e r n ed  a re  c o v e r ed  by  the  s c o pe  of  t h is  d i r e c t i v e. 

T he  a m e n d m e nt  of  D i r e c t i ve  8 4 / 5 3 9 / E EC  r e s t r i c ts  its  s c o pe  to 
e l e c t r o - m e d i c al  e q u i p m e nt  u s ed  in  v e t e r i n a ry  m e d i c i n e. 
E q u i p m e nt  u s ed  in  h u m an  m e d i c i ne  is  c o v e r ed  by  t h is 
p r o p o sa  I. 

T he  p u r p o se  of  a m e n d i ng  D i r e c t i ve  9 0 / 3 8 5 / E EC  is  to  a dd  to 
that  D i r e c t i ve  t he  g e n e r al  p r o v i s i o ns  in  t h is  p r o p o s al  so  as 
to  a p p ly  t h em  to  all  m e d i c al  d e v i c e s.  T he  e x i s t i ng 
p r o v i s i o ns  of  D i r e c t i ve  9 0 / 3 8 5 / E EC  a re  not  a f f e c t e d.  T he 
a m e n d m e n ts  w i ll  t h e r e f o re  not  h a ve  any  e f f e ct  on  t he 
t r a n s p o s i t i on  of  the  a b o v e m e n t i o n ed  D i r e c t i v e. 

1 7. 

A r t i c le  23  -  I m p l e m e n t a t i o n,  t r a n s i t i o n al  p r o v i s i o ns 

A r t i c le  2 3,  p a r a g r a ph  4,  p r o v i d es  for  the  o p t i o n al 
a p p l i c a t i on  of  t he  d i r e c t i ve  up  to  J u ne  1 9 97  to  m e d i c al 
d e v i c es  w h i ch  m u st  u n d e r go  c e r t i f i c a t i on  by  a  t h i rd  p a r t y. 
T h is  p e r i od  is  n e c e s s a ry  in  o r d er  to  a v o id  t he  a d d i t i o n al 
c e r t i f i c a t i on  w o r k l o ad  w h i ch  w o u ld  a r i se  w i th  a  s h o r t er 
t r a n s i t i o n al  p e r i o d.  To  a v o id  the  u n n e c e s s a ry  r e p e t i t i on  of 
t e s ts  a nd  v e r i f i c a t i o n s,  A r t i c le  2 3,  p a r a g r a ph  3,  s t a t es 
t h at  t he  n o t i f i ed  b o d i es  m u st  t a ke  a c c o u nt  of  t he  r e s u l ts  of 
t e s ts  a nd  v e r i f i c a t i o ns  a l r e a dy  c a r r i ed  out  u n d er  p r e 
e x i s t i ng  n a t i o n al  r e g u l a t i o n s. 

-  13  -

1 8. 

A n n ex  1  -  E s s e n t i al  r e q u i r e m e n ts 

T h is  A n n ex  is  l a r g e ly  b a s ed  on  D i r e c t i ve  9 0 / 3 8 5 / E E C. 

1 9. 

A n n ex  8  -  P r o c e d u r es  for  d e v i c es  for  s p e c i al  p u r p o s es 

T he  p r o c e d u r es  and  s t a t e m e n ts  r e f e r r ed  to  in  t h is  A n n ex 
a p p ly  to  c u s t o m - m a de  d e v i c es  and  d e v i c es  i n t e n d ed  for 
c l i n i c al  i n v e s t i g a t i o n s. 
a d o p t ed  in  the  C o u n c il  D i r e c t i ve  r e l a t i ng  to  a c t i ve 
i m p l a n t a b le  m e d i c al  d e v i c e s. 

T h ey  are  b a s ed  on  t he  s o l u t i on 

2 0. 

A n n ex  9  -  C l a s s i f i c a t i on  r u l es 

T h is  A n n ex  lays  d o wn  the  r u l es  for  the  c l a s s i f i c a t i on  of 
m e d i c al  d e v i c es  for  the  a p p l i c a t i on  of  the  c o n f o r m i ty 
a s s e s s m e nt  p r o c e d u r e s.  T he  c o n c e pt  of  c l a s s i f i c a t i on  is 
e s s e n t i a l ly  b a s ed  on  the  v u l n e r a b i l i ty  of  the  h u m an  b o dy 
f o l l o w i ng  the  u se  of  a  m e d i c al  d e v i c e. 
a c c o u nt  of  the  c o n s e q u e n c es  of  f u n c t i o n al  d e f e c ts  in  m e d i c al 
d e v i c e s. 
a re  as  f o i l o w s: 

T he  b a s ic  c r i t e r ia  for  the  c l a s s i f i c a t i on  r u l es 

It  a l so  t a k es 

c o n t a ct  or  i n t e r a c t i on  of  a  d e v i ce  w i th  the  h u m an  b o d y; 
c o n t a ct  w i th  i n j u r ed  skin-, 
the  i n v a s i ve  n a t u re  of  a  d e v i ce  w i th  r e g a rd  to  t he 
o r i f i c es  of  the  h u m an  b o dy  or  of  a  s u r g i c al  d e v i c e; 
i m p l a n t a t i on  of  a  d e v i ce  in  the  b o d y; 
c o n t a ct  w i th  v i t al  o r g a ns  ( h e a r t,  c e n t r al  n e r v o us 
s y s t e m) ; 
the  d e l i v e ry  of  e n e r gy  or  s u b s t a n c es  into  or  o n to  the 
b o dy . 

On  the  a b o ve  b a s i s,  d e v i c es  w h i ch  do  not  e n t er  into  c o n t a ct 
or  i n t e r a ct  w i th  the  b o dy  a re  g e n e r a l ly  c l a s s i f i ed  in  C l a ss 
I . 

D e v i c es  w h i ch  a re  i n v a s i ve  or  i m p l a n t a b le  or  w h i ch  i n t e r a ct 
w i th  the  b o dy  a re  l a r g e ly  ( a p a rt  from  c e r t a in  p a r t i c u l ar 
a s p e c t s)  in  C l a ss  Ma  or 

M b. 

-  14  -

A  s m a ll  n u m b er  of  d e v i c es  c o n c e r n i ng  in  p a r t i c u l ar  the 
f u n c t i o ns  of  v i t al  o r g a ns  a re  in  C l a ss  I I I.  D e v i c es  w h i ch 
a re  a c t i v a t ed  by  an  e n e r gy  s o u r ce  and  w h i ch  in  p r i n c i p le 
s h o u ld  be  in  C l a ss  III  a re  a l r e a dy  c o v e r ed  by  the  D i r e c t i ve 
r e l a t i ng  to  a c t i ve  i m p l a n t a b le  m e d i c al  d e v i c e s.  T he 
p r o v i s i o ns  of  that  D i r e c t i ve  c o r r e s p o nd  to  t h o se  laid  d o wn 
for  CI a ss  I I I  d ev i c e s. 

21 

A n n ex  10  -  C l i n i c al  e v a l u a t i on 

A n n ex  10  h as  b e en  a d o p t ed  f r om  the  D i r e c t i ve  r e l a t i ng  to 
a c t i ve  i m p l a n t a b le  m e d i c al  d e v i c e s.  It  s p e c i f i es  the  s u b j e ct 
of  t he  c l i n i c al  d a ta  and  the  p r o c e d u r es  to  be  f o l l o w ed  for 
o b t a i n i ng  the  d a t a.  C l i n i c al  e v a l u a t i on  is  c a r r i ed  out  u n d er 
t he  m a n u f a c t u r e r 's  r e s p o n s i b i l i t y.  It  m ay  be  a  f e a t u re 
r e q u i r ed  in  the  t e c h n i c al  d o c u m e n t a t i on  r e f e r r ed  to  in  the 
c o n f o r m i ty  a s s e s s m e nt  p r o c e d u r e s. 
c o n t a i n ed  in  t h is  A n n ex  w i ll  a v o id  r e p e t i t i on  of  the  s a me 
c l i n i c al  i n v e s t i g a t i o ns  in  m o re  t h an  o ne  M e m b er  S t a t e. 

T he  h a r m o n i z ed  p r o v i s i o ns 

2 2. 

A n n e x es  11  a nd  12  -  M i n i m um  c r i t e r ia  for  the  n o t i f i ed 
bod i es .  EC  m a rk 

T h e se  a re  A n n e x es  t y p i c al  of  the  n ew  a p p r o a ch  d i r e c t i v e s. 

-  15  -

Proposal  for a 

COUNCIL DIRECTIVE 

concerning medical  devices 

THE COUNCIL OF THE EUROPEAN  COMMUNITIES 

Having  regard  to  the  Treaty  establishing  the  European  Economic  Community, 

and  in particular Article 100a  thereof, 

Having  regard  to the proposal  from  the  Commission^), 

In cooperation with  the European Par Iiament^2), 

Having  regard  to the opinion of  the Economic and Social  Committee^3), 

Whereas measures should  be adopted  for  the progressive establishment  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; 

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  of  medical  devices  are 

different;  whereas  the  certification  and  inspection  procedures  for  such 

devices  differ  from  one Member  State  to another;  whereas  such  disparities 

constitute barriers  to trade within  the Community-, 

Whereas  the  national  provisions  for  the  safety  and  health  protection  of 

patients, users  and,  where  appropriate,  other  persons, with  regard  to  the 

use of medical  devices  should  be harmonized  in order  to guarantee  the  free 

movement  of such devices within  the  internal  market; 

(1)  OJ No C 
(2)  OJ No C 
(3)  OJ No C 

-  16  -

Whereas  the  harmonized  provisions  must  be  distinguished  from  the  measures 

adopted  by  the  Member  States  to  manage  the  funding  of  public  health  and 

sickness  insurance schemes  relating directly or  Indirectly  to such devices; 

whereas,  therefore,  these  provisions  do  not  affect  the  ability  of  the 

Member  States  to  implement  the  abovementioned  measures  provided  Community 

law  is complied with; 

Whereas  medical  devices  should  provide  patients,  users  and  third  parties 

with  a  high  level  of  protection  and  attain  the  performance  levels 

attributed  to  them  by  the  manufacturer;  whereas,  therefore,  the 

maintenance  or  improvement  of  the  level  of  protection  attained  in  the 

Member  States  is one of  the essential objectives of  this Directive; 

Whereas  certain  medical  devices  are  intended  to  administer  medicinal 

products 

within 

the  meaning 

of 

Council 

Directive 65/65/EEC  of 

26 January  1965  on  the  approximation  of  provisions  laid  down  by  law, 

regulation  or  administrative  action  relating  to  proprietary  medicinal 

products^4),  as  last  amended  by  Directive 89/381/EEC^5^;  whereas,  in 

such  cases  the  placing  of  the medicinal  product  on  the market  is governed 

by  Directive 65/65/EEC;  whereas  a  distinction  must  be  drawn  between  the 

abovementioned  devices  and  medical  devices  incorporating, 

inter 

alia, 

substances  which,  if used  separately,  may  be  considered  to be  a medicinal 

substance  within  the  meaning  of  Directive 65/65/EEC;  whereas,  in  such 

cases,  if  the  substances  are  incorporated  in  the  medical  devices  to  help 

them operate,  the placing  of  the devices on  the market  is governed  by  this 

Directive;  whereas,  in  this  context,  in  the  event  of  the  bioavailability 

of  such  substances,  the  safety,  quality  and  usefulness  of  the  substances 

must  be  verified  by  analogy  with  the  appropriate  methods  specified  in 

Council  Directive 75/318/EEC  of  20 May  1975  on  the  approximation  of  the 

laws  of  the  Member  States  relating  to  analytical,  pharmaco-toxicological 

and  clinical  standards  and  protocols  in  respect  of  the  testing  of 

proprietary  medicinal 

products*6^,  as  last  amended  by  Directive 

89/341/EEC<7), 

(4)  OJ No L 22, 9.2.1965,  p. 369/65. 
(5)  OJ No L 181, 28.6.1989, p. 44. 
(6)  OJ No L 147, 9.6.1975,  p. 1. 
(7)  OJ No L 142, 25.5.1989, p. 11. 

-  17  -

Whereas,  in  accordance  with  the  principles  set  out  in  the  Council 

Resolution  of  7 May  1985  concerning  a  new  approach  to  technical 

harmonization  and  standardization<8),  rules  regarding  the  design  and 

manufacture  of medical  devices 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 should  be applied with discrimination to 

take account  of  the  technological  level  existing  at  the  time of  design  and 

of  technical  and economic considerations; 

Whereas  Council  Directive 90/385/EEC  of  20 June 1990  on  the  approximation 

of  the  laws  of  the  Member  States  relating  to  active  implantable  medical 

devices^9)  is  the  first  case  of  application  of  the  new  approach  to  the 

field  of  medical  devices;  whereas  in  the  interest  of  uniform  Community 

rules applicable  to all  medical  devices, this Directive  is based  largely on 

the  provisions  of  Directive 90/385/EEC;  whereas,  for  the  same  reasons, 

Directive 90/385/EEC  must  be  amended  to  insert  the general  provisions  laid 

down  in this D i rect i ve; 

Whereas  the electromagnetic  compatibility  aspects  form  an  integral  part  of 

the  safety  of  medical  devices;  whereas  this  Directive  should  contain 

specific  rules on  this subject  with  regard  to  Council  Directive  89/336/EEC 

of  3 May  1989  on  the  approximation  of  the  laws  of  the  Member  States 

relating  to  electromagmetic  compatibiIity(1°),  as  amended  by  Directive 

91/263/EEC<1D 

Whereas  this Directive  should  include requirements  regarding  the design and 

manufacture of devices emitting  ionizing  radiation-,  whereas  this Directive 

does 

not 

affect 

the 

authorization 

required 

by 

Council 

Directive 80/836/Euratom  of  15 July  1980  amending  the  Directives  laying 

down  the  basic  safety  standards  for  the  health  protection  of  the  general 

public  and  workers  against  the  dangers  of  ionizing  radiâtion^12),  as 

amended  by  Directive 84/467/Euratom(13),  nor  application  of  Council 

Directive 84/446/Euratom  of  3 September  1984  laying down basic measures for 

(8)  OJ No C 136, 4.6.1985, p. 1. 
(9)  OJ No L 189, 20.7.1990, p. 17. 
(10) OJ No L 139, 23.5.1989, p. 19. 
(11) OJ  No L 128, 23.5.1991, p. 1. 
(12) OJ No L 246, 17.9.1980, p. 1. 
(13) 0J No L 265, 5.10.1984, p. 4. 

-  18  -

the  radiation  protection  of  persons  undergoing  medical  examination  or 

treatmentC14). whereas  Council  Directive 89/391/EEC of  12 June  1989 on  the 

introduction of measures  to encourage  improvements  in the safety  and  health 

of  workers  at  work^15)  and  the  specific  directives  on  the  same  subject 

should  continue to apply; 

Whereas  this  Directive  does  not  affect  Council  Directive 76/768/EEC  of 

27 July  1976 on  the approximation of  the  laws of  the Member  States  relating 

to  cosmetic  products(16),  as  last  amended  by  Direct ive 91/184/EEC(17) -, 

whereas  the  assessment  whether  a product  is subject  to  the  abovementioned 

Directive  or  to  this  Directive  must  take  account,  in  particular,  of  the 

intended  purpose  of  the  product  in  question  and  of  the  place  of 

applicat ion; 

Whereas,  in  order  to  demonstrate  conformity  with  these  essential 

requirements  and  to  enable  conformity  to  be  verified,  it  is desirable  to 

have  harmonized  European  standards  to protect  against  the  risks  associated 

with  the  design,  manufacture  and  packaging  of  medical  devices-,  whereas 

such  harmonized  European  standards  are  drawn  up  by  private-1 aw  bodies  and 

should  retain  their  status  as  non-mandatory  texts-,  whereas,  to  this  end, 

the European Committee  for Standardization  (CEN) and  the European  Committee 

for  Electrotechnical  Standardization  (CENELEC)  are  recognized  as  the 

competent  bodies  for  the  adoption  of  harmonized  standards  in  accordance 

with  the general  guidelines on cooperation  between  the Commission  and  these 

two bodies signed on  13 November  1984; 

Whereas,  for  the  purpose  of  this  Directive,  a  harmonized  standard  is a 

technical  specification  (European  standard  or  harmonization  document) 

adopted,  on  a  mandate  from  the  Commission,  by  either  or  both  of  these 

bodies  in  accordance  with  Council  Directive 83/189/EEC  of  28 March  1983 

laying  down  a  procedure  for  the  provision  of  information  in  the  field  of 

technical  standards  and  régulâtions^18),  as  last  amended  by  Commission 

Decision  90/230/EEC^19),  and  pursuant  to  the  abovementioned  general 

guidelines;  whereas  with  regard  to  possible  amendment  of  the  harmonized 

standards,  the Commission  should  be assisted  by  the Committee  set  up under 

(14) OJ  No L 265, 5.10.1984, p. 1. 
(15) OJ No L 183, 29.6.1989, p. 1. 
(16) OJ No L 262, 27.9.1976, p. 169 
(17) OJ  No L 91, 12.4.1991, p. 59. 
(18) OJ No L 109, 26.4.1983, p. 8. 
(19) OJ No L 128, 18.5.1990, p. 15. 

(4) 

-  19  -

Directive  83/189/EEC-,  whereas  the  measures  to  be  taken  must  be  defined  in 

line  with  procedure  I,  as  laid  down  in  Council  Decision  87/373/EEC^2 0); 

whereas,  for  specific  fields,  what  already  exists  in  the  form  of  European 

Pharmacopoeia  monographs  should  be  incorporated  within  the  framework  of 

this  Directive;  whereas, 

therefore,  several 

European 

Pharmacopoeia 

monographs  may  be  considered  equal  to  the  abovementioned  harmonized 

standards; 

Whereas,  in  Decision  90/683/EEC  of  13 December  1990  concerning  the  modules 

for  the  various  phases  of  the  conformity  assessment  procedures  which  are 
intended  to  be  used  in  the  technical  harmonization  d i r e c t i v e s ^2Dt  the 

Council  has 

laid  down  harmonized  conformity  assessment 

procedures; 

whereas  the  application  of  these  modules  to  medical  devices  enables  the 

responsibility  of  manufacturers  and  certification  bodies  to  be  determined 

during  conformity  assessment  procedures  on  the  basis  of  the  type  of  devices 

concerned;  whereas  the  details  added  to  these  modules  are  justified  by  the 

nature  of  the  verification  required  for  medical  devices-, 

Whereas  it  is  necessary,  essentially  for  the  purpose  of  the  conformity 

assessment  procedures,  to  group  the  devices  into  four  product  classes; 

whereas  the  classification  rules  are  based  on  the  vulnerability  of  the 

human  body  taking  account  of  the  potential  risks  associated  with  the 

technical  design  and  manufacture  of  the  devices;  whereas  the  conformity 

assessment  procedures  for  Class  I devices  can  be  carried  out,  as  a  general 

rule,  under  the  sole  responsibility  of  the manufacturers  in view  of  the  low 

level  of  vulnerability  associated  with  these  products;  whereas,  for 

Class  lia devices,  the  intervention  of  a certification  body  (notified  body) 

should  be  compulsory  at  the  production  stage;  whereas,  for  devices  falling 

within  Classes  lib  and  III  which,  in case  of  malfunction,  constitute  a  high 

risk  potential,  inspection  by  a  notified  body  is  required  with  regard  to 

the  design  and  manufacture  of  the  devices;  whereas  Class  III  is  set  aside 

for  the  most  critical  devices  for  which  explicit  prior  authorization  with 

regard  to  conformity  is required  for  them  to  be  placed  on  the  market; 

(20) OJ  No  L  197,  18.7.1987,  p.  33. 
(21) OJ  No  L  380,  31.12.1990,  p.  13 

-  20  -

Whereas  in  cases  where  the  conformity  of  the  devices  can  be  assessed  under 

the  responsibility  of  the  manufacturer  the  competent  authorities  must  be 

able,  particularly  in  emergencies,  to  contact  a  person  responsible  for 

placing  the  device  on  the  market  and  established  in  the  Community,  whether 

the  manufacturer  or  another  person  established  in  the  Community  and 

designated  by  the  manufacturer  for  the  purpose-, 

Whereas  medical  devices  should,  as  a  general  rule,  bear  the  EC  mark  to 

indicate  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; 

Whereas,  in  the  fight  against  AIDS  and  in  the  light  of  the  conclusions  of 

the  Council  adopted  on  16 May  1989  regarding  future  activities  on  AIDS 

prevention  and  control  at  Community  level^2 2),  medical  devices  used  for 

protection  against  the  HIV  virus  must  afford  a  high  level  of  protection; 

whereas  the  design  and  manufacture  of  such  products  should  be  verified  by  a 

not i f i ed  body -, 

Whereas  the  classification  rules  generally  enable  medical  devices  to  be 

appropriately  classified;  whereas,  in  view  of  the  diverse  nature  of  the 

devices  and  technological  progress  in  this  field,  steps  must  be  taken  to 

include  amongst  the  implementing  powers  conferred  on  the  Commission  the 

decisions  to  be  taken  with  regard  to  the  proper  classification  or 

reclassification  of  the  devices  or,  where  appropriate,  the  adjustment  of 

the  classification  rules  themselves;  whereas  since  these  issues  are 

closely  connected  with  the  protection  of  health,  it  is  appropriate  that 

these  decisions  should  come  under  procedure  lll(a),  as  provided  for  in 

Decision  87/373/EEC; 

Whereas  it  is  appropriate  that  the  Member  States,  as  provided  for  by 

Article  100a  of  the  Treaty,  may  take  temporary  measures  to  limit  or 

prohibit  the  placing  on  the  market  and  the  use  of  medical  devices  in  cases 

where  they  present  a  particular  risk  to  the  health  of  persons,  provided 

that  the  measures  are  subject  to  a Community  control  procedure-, 

(22) OJ  No  C  185,  22.7.1989,  p.8. 

-  21  -

Whereas  the  confirmation  of  compliance  with  the  essential  requirements  may 

mean  that  clinical 

investigations  have  to  be  carried  out  under  the 

responsibility  of  the  manufacturer;  whereas,  for  the  purpose  of  carrying 

out  the  clinical  investigations,  appropriate  means  have  to  be  specified  for 

the  protection  of  public  health  and  public  order; 

Whereas  the  application  of  some  provisions  of  this  Directive  must  be 

facilitated  by  means  of  guidelines  published  by  the  Commission; 

Whereas  the  protection  of  health  and  the  associated  controls  may  be  made 

more  effective  by  means  of  a  medical  device  vigilance  system  at  Community 

I eve I ; 

Whereas  this  Directive  covers  the  medical  devices  referred  to  in  Council 

Directive  76/764/EEC  of  27  July  1976  on  the  approximation  of  the  laws  of 

the 

Member 

States 

on 

clinical 

mercury-in-glass, 

maximum 

reading 

thermometers^2 3^,  as  last  amended  by  Directive  8 4 / 4 1 4 / E E C ^2 4);  whereas 

the  abovementioned  Directive  must  therefore  be  repealed;  whereas  for  the 

same  reasons  Council  Directive  84/539/EEC  of  17  September  1984  on  the 

approximation  of  the  laws  of  the  Member  States  relating  to  electro-medical 

equipment  used  in  human  or  veterinary  medicine^2 5) must  be  amended, 

HAS  ADOPTED  THIS  DIRECTIVE: 

Article  1 

Definitions,  scope 

1. 

This  Directive  shall  apply  to  medical  devices.  It  also  covers  the 

accessories  to  which  the  provisions  for  medical  devices  apply. 

2. 

For  the  purposes  of  this  Directive,  the  following  definitions  shall 

apply: 

(23) OJ  No  L  262,  27.9.1976,  p.  139. 
(24) OJ  No  L  228,  25.8.1984,  p.  25. 
(25) OJ  No  L  300,  19.11.1984,  p.  179 

-  22  -

(a) 

"medical  device"  (hereinafter  referred  to  as  "devices")  means  any 

instrument,  apparatus,  appliance,  material 

or  other 

article, 

including  software,  whether  used  alone  or  in  combination,  intended 

by  the manufacturer  to  be  used  on  human  beings  solely  or  principally 

for  the  purpose  of: 

diagnosis,  prevention,  monitoring,  treatment  or  alleviation  of 

disease,  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. 

(b) 

"accessory"  means  an  article  which,  while  not  a device,  is  required, 

according  to  the  intended  purpose  attributed  to  it  by  the 

manufacturer,  to  enable  a  device  to be  used  as  specified. 

(c) 

"device  used  for 

in  vitro 

diagnosis"  means  any  device  which  is  a 

reagent,  reagent  product,  kit,  instrument,  equipment  or  system, 

whether  used  alone  or  in  combination,  intended  by  the  manufacturer 

to  be  used  solely  or  principally 

in  vitro 

for  the  examination  of 

substances  derived  from  the  human  body  with  a  view  to  providing 

information  for  the  detection,  diagnosis,  control  or  treatment  of  a 

physiological  state,  of  a  state  of  health  or  disease,  or  of  a 

congen i ta I abnormaI i ty. 

(d) 

"custom-made 

device"  means  any  device  specifically  made 

in 

accordance  with  a  duly  qualified  medical  practitioner's  written 

prescription  which  gives,  under  his  responsibility,  specific  design 

characteristics  and  is  intended  to  be  used  only  for  an  individual 

named  pat ient. 

The  abovement ioned  prescription  may  also  be  made  out  by  any  other 

person  authorized  by  virtue  of  his  professional  qualifications  to  do 

so. 

-  23  -

Mass-produced  devices  which  need  to  be  adapted  to  meet  the  specific 

requirements  of  the  medical  practitioner  or  any  other  professional 

user  are  not  considered  to be  custom-made  devices. 

(e) 

"device  intended  for  clinical  investigation"  means  any  device 

intended  for  use  by  a  duly  qualified  medical  practitioner  when 

conducting  investigations  as  referred  to  in point  2.1  of  Annex  10  in 

an  adequate  human  clinical  environment. 

For  the  purpose  of  conducting  clinical  investigation,  any  other 

person  who,  by  virtue  of  his  professional  qualifications,  is 

authorized  to  carry  out  such  investigation  shall  be  accepted  as 

equivalent  to  a  duly  qualified  medical  specialist. 

(f) 

"implantable  device"  means  any  device  which  is  intended: 

to be  totally  or  partially  introduced  into  the  human  body  or  a 

natural  or if ice or 

to  replace  an  epithelial  surface  or  the  surface  of  the  eye 

by  surgical  intervention,  which  is  intended  to  remain  after  the 

procedure  for  at  least  30 days,  and  which  can  only  be  removed  by 

medical  or  surgical  Intervention. 

(g) 

"manufacturer"  means  the  natural  or  legal  person  with  overall 

responsibility  for  the  design,  manufacture,  packaging  and  labelling 

of  a  device  before  it  is  placed  on  the  market  on  his  own  behalf, 

regardless  of  whether  these  operations  are  carried  out  by  that 

person  himself  or  on  his  behalf  by  a  third  party. 

The  natural  or  legal  person  who  assembles,  packages,  processes 

and/or  labels  one  or  more  ready-made  products  and/or  assigns  to  them 

their  intended  purpose  as  a  device  with  a view  to  their  being  placed 

on  the  market  on  his  own  behalf  is  also  considered  to  be  a 

manufacturer.  This  sub-paragraph  does  not  apply  to  the  person  who, 

while  not  a  manufacturer 

within  the  meaning  of  the  first 

sub-paragraph,  assembles  or  adapts  devices  already  on  the  market  to 

their  intended  purpose  for  an  individual  patient. 

-  24  -

(h) 

"intended  purpose"  means  the  use  for  which  the  device  is  intended 

and  for  which  it  is  suited  according  to  the  data  supplied  by  the 

manufacturer  on  the  labelling,  in  the  instructions  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  clinical  investigation,  with  a  view  to  distribution 

and/or  use on  the Community  market,  regardless of whether  it  is new 

or  fully  refurbished. 

(j) 

"putting  into  service"  means  the  stage  when  a  device  is  ready  for 

use  for  the  first  time  on  the  Community  market  for  its  intended 

purpose. 

(k) 

"bioavailability" means  the  release of  a substance  into or  onto  the 

human  body  in  such  a  way  that  the  interaction  with  the  body  can 

reasonably  be detected. 

3. 

Where  a  device  is  intended  to  administer  a  substance  defined  as a 

medicinal 

product 

within 

the 

meaning 

Article  1 

of 

Directive 65/65/EEC,  that  substance  shall  be  subject  to  the 

marketing  authorization system  provided  for  in that  Directive. 

4. 

Where  a device  incorporates, as an  integral  part, a substance which, 

if  used  separately,  may  be  considered  to  be  a  medicinal  product 

within  the meaning  of  Article  1 of  Directive 65/65/EEC,  that  device 

must  be assessed  and  authorized  in accordance with  this Directive. 

5. 

This Directive does not  apply  to: 

(a) 

devices used  for  in  vitro  diagnosis, 

(b)  active  implantable  devices covered  by  Directive 90/385/EEC. 

6. 

This  Directive  is  a  specific  directive  within  the  meaning  of 

Article  2(2) of  Directive  89/336/EEC. 

7. 

This 

Directive 

does 

not 

affect 

the 

application 

of 

Directive  80/836/Euratom,  nor  of  Directive  84/466/Euratom. 

-  25  -

8. 

This 

Directive 

does 

not 

affect 

the 

application 

of 

Directive  76/768/EEC.  The  assessment  whether  a  product  is  subject 

to  the  abovementioned  Directive  or  to  this  Directive  shall  take 

account,  in  particular,  of  the  intended  purpose  of  the  product  in 

question  and  of  the  place  of  application. 

Art i cle  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  put  into  service  only  if  they  do  not  compromise 

the  safety  and  health  of  patients,  users  and,  where  applicable,  other 

persons  when  properly  installed,  maintained  and  used  in  accordance  with 

their  intended  purpose. 

Art i cle  3 

Essential  reguirements 

The  devices  must  meet  the  essential  requirements  set  out  in  Annex  1  which 

apply  to  them,  taking  account  of  the  intended  purpose  of  the  devices 

concerned. 

Art i cle  4 

Free  movement,  devices  intended  for  special  purposes 

1. 

Member  States  shall  not  create  any  obstacles  to  the  placing  on  the 

market  or  the  putting  into  service  within  their  territory  of  devices 

bear ing  the  EC  mark. 

2. 

Member  States  shall  not  create  any  obstacles  to: 

devices 

intended 

for  clinical 

investigation  being 

made 

available  to  medical  specialists  or  authorized  persons  for 

that  purpose  if  they  meet  the  conditions  laid  down  in 

Article  15  and  in Annex  8. 

-  26  -

custom-made  devices  being  placed  on  the  market  and  put  into 

service  if  they  meet  the  conditions  laid  down  in Article  11  in 

combination  with  Annex  8-, Class  M a,  lib  and  III  devices  shall 

be  accompanied  by  the  statement  referred  to  in Annex  8. 

These  devices  shall  not  bear  the  EC  mark. 

3. 

At  trade  fairs,  exhibitions,  demonstrations,  etc.  Member  States 

shall  not  create  any  obstacles  to  the  showing  of  devices  which  do 

not  conform  to  this  Directive,  provided  that  a  visible  sign  clearly 

indicates  that  such  devices  cannot  be  marketed  or  put  into  service 

until  they  have  been  made  to  comply. 

4. 

Member  States  may  require  the  information  referred  to  in points  13.3 

and  13.6  of  Annex  1  to  be  in  their  national  language(s)  when  a 

device  reaches  the  final  user,  regardless  of  whether  it  is  for 

professional  or  other  use. 

Art icle 5 

Reference  to  standards 

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  provisions  of  the  harmonized 

standards,  the  references  of  which  have  been  published  in  the 

Official  Journal  of  the  European  Communities.  Member  States  shall 

publish  the  references  of  the  national  standards  which  transpose  the 

abovementioned  harmonized  standards  into national  law. 

2. 

For  the  purposes  of  this  Directive,  reference  to  harmonized 

standards  also  includes  the monographs  of  the  European  Pharmacopoeia 

on  surgical  sutures  and  on  interaction  between  medicinal  products 

and  materials  used  as  containers  for  devices,  the  references  of 

which  have  been  published  in  the  Official  Journal  of  the  European 

Commun i t i es. 

-  27  -

3. 

Where  the  Commission,  whether  on  its  own  initiative  or  at  the 

request  of  one  of  the  Member  States,  considers  that  the  harmonized 

standards  do  not  entirely  meet  the  essential  requirements  referred 

to  in Article  3,  the  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 ). 

Article  6 

Committee  on  Standards  and  Technical  Regulations 

1. 

The  Commission  shall  be  assisted  by  the  committee  set  up  by 

Article  5 of  Directive  83/189/EEC. 

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. 

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. 

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. 

Art icle  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. 

-  28  -

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.  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  in 

accordance  with  the  opinion  of  the  committee. 

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 

major ity. 

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  may  examine  any  question  connected  with  implement ion 

of  this  Direct ive. 

Art icle  8 

Safeguard  clause 

1. 

Where  a  Member  State  ascertains  that  the  devices,  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,  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 

its  decision 

and, 

in 

particular,  whether  non-compliance  with  this  Directive  is due  to: 

-  29  -

(a)  failure  to  meet  the  essential  requirements  referred  to  in 

Art icle 3; 

(b) 

incorrect  application  of  the  standards  referred  to  in 

Article 5,  in  so  far  it  is  claimed  that  the  standards  have 

been applied; 

(c)  shortcomings  in the standards themselves. 

These  measures  are applicable  until  the entry  into force of  the act 

provided  for  in paragraph  2. 

2. 

The  measures  adopted  under  paragraph  1  shall  be  confirmed  and 

extended, possibly amended,  to the whole Community  or  repealed by an 

act of  the Commission. 

However,  where  the  measures  were  adopted  under  paragraph  1 on  the 

ground  of  a shortcoming  in the standards  provided  for  in Article 5, 

the procedure  laid down  in Article 6(2)  is applicable. 

3. 

Where  a  non-complying  device  bears  the  EC  mark,  the  competent 

Member  State  shall  take  appropriate  action  against  whomsoever  has 

affixed  the  mark  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. 

Art icle 9 

Classification 

1. 

Devices  shall  be  divided  into  Classes  I,  lia,  Mb  and  III. 

Classification  shall  be  carried  out  in  accordance  with  the 

classification  rules set out  in Annex  9. 

-  30  -

2. 

Where  there  is  doubt  over  the  classification  resulting  from 

application  of  the  rules  contained  in  Annex  9,  the  manufacturer  or 

his  authorized  representative  established  in  the  Community  may  ask 

the  competent  authorities  to  take  a  decision.  In  the  event  of  a 

dispute  between  the  manufacturer  and  the  notified  body  concerned 

defined  in  Article  16  resulting  from  the  application  of  the 

abovementioned  rules,  the  latter  shall  refer  the  matter  to  the 

competent  authorities  who  will  reach  a  decision. 

3. 

The  classification  rules  set  out  in  Annex  9  may  be  adapted  in 

accordance  with  the  procedure  referred  to  in  Article  7(2)  in  the 

light  of  technical  progress  and  any  information  which  becomes 

available  under  the  information  system  provided  for  in Article  10. 

Art icle  10 

Information  on  incidents  occurring  following  placing 

of  devices  on  the  market 

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  the  incidents  mentioned 

below  involving  a  Class  M a,  Mb  or  III  device  is  recorded  and 

evaluated  in a  centralized  manner: 

(a) 

any  deterioration  in  the  characteristics  and/or  performance  of 

a  device,  as  well  as  any  inaccuracies  in  the  labelling  or  the 

instruction  leaflet  which  might  lead  to  or  might  have  led  to 

the  death  of  a  patient  or  user  or  to  a  serious  deterioration 

in his  state  of  health; 

(b) 

any  technical  or  medical  reason  connected  with  the  device 

leading  to  systematic  recall  of  devices  of  the  same  type  by 

the  manufacturer. 

-  31  -

2. 

Where  a  Member  State  obliges  medical  practitioners  or  the  medical 

institutions  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 

authorized  representative  established  in  the  Community,  is  also 

informed  of  the  incident. 

3. 

After  carrying  out  an  assessment,  if  possible  together  with  the 

manufacturer,  Member  States  shall,  without  prejudice  to  Article  8, 

immediately  inform  the Commission  and  the other  Member  States  of  the 

incidents  referred  to  in  paragraph  1  for  which  relevant  measures 

have  been  taken  or  are  contemplated. 

4. 

The  Commission  shall  adopt  the  necessary  measures  concerning  the 

functioning  of  the  information  system  referred  to  in paragraphs  1,  2 

and  3 and  the  presentation  of  information. 

Article  11 

Conformity  assessment  procedures 

1. 

In  the  case  of  devices  failing  within  Class  III, other  than  devices 

which  are  custom-made  or  intended  for  clinical  investigations,  the 

manufacturer  shall,  in order  to  affix  the  EC mark,  either: 

(a) 

follow  the  procedure  relating  to  the  EC  declaration  of 

conformity  set  out  in Annex  2  (full  quality  guarantee),  or 

(b) 

follow  the  procedure  relating  to  EC  type-examination  set  out 

in Annex  3,  coupled  with: 

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

Annex  4, or 

(ii)  the  procedure  relating  to  the  EC  declaration  of 

conformity  set  out 

in  Annex  5  (production  quality 

guarantee). 

-  32 -

2. 

In the case of  devices  falling within  Class  M a,  other  than  devices 

which  are  custom-made  or  intended  for  clinical  investigations,  the 

manufacturer  shall,  in  order  to  affix  the  EC  mark,  follow  the 

procedure  relating  to  the  EC  declaration  of  conformity  set  out  in 

Annex 7, coupled with either: 

(a)  the procedure  relating  to EC verification  set  out  in Annex  4, 

or 

(b)  the procedure  relating  to the EC declaration of conformity  set 

out  in Annex  5 (production  quality  guarantee), or 

(c)  the procedure  relating  to the EC declaration of conformity  set 

out  in Annex  6  (product  quality guarantee). 

Instead  of  applying  these  procedures,  the  manufacturer  may  also 

follow  the procedure  referred  to  in paragraph 3(a). 

3. 

In the case of  devices  falling within  Class  lib, other  than  devices 

which  are  custom-made  or  intended  for  clinical  investigations,  the 

manufacturer  shall,  in order  to affix  the EC mark, either: 

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

conformity  set  out  in  Annex  2  (full  quality  guarantee);  in 

this case, point  4 of Annex  2  is not  applicable-, or 

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

in Annex  3, coupled with: 

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

Annex  4, or 

(ii) the  procedure  relating  to  the  EC  declaration  of 

conformity  set  out  in  Annex  5  (production  quality 

guarantee), or 

( M i) 

the  procedure  relating  to  the  EC  declaration  of 

conformity  set  out  in  Annex  6  (product  quality 

guarantee). 

-  33  -

4. 

In  the  case  of  devices  falling  within  Class  I,  other  than  devices 

which  are  custom-made  or  intended  for  clinical  investigations,  the 

manufacturer  shall  follow  the  procedure  referred  to  in  Annex  7  and 

draw  up  the  EC  declaration  of  conformity  required  before  placing  the 

device  on  the  market. 

5. 

In  the  case  of  custom-made  devices,  the  manufacturer  shall  follow 

the  procedure  referred  to  in  Annex  8  and  draw  up  the  statement  set 

out  in  that  Annex  before  placing  each  device  on  the  market. 

6. 

During  the  conformity  assessment  procedure  for  a  device,  the 

manufacturer  and/or  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  stage  of  manufacture. 

7. 

The  manufacturer 

may 

instruct 

his  authorized 

representative 

established  in  the  Community  to  initiate  the  procedures  provided  for 

in Annexes  3,  4,  7  and  8. 

8. 

Where  the  conformity  assessment  procedure  involves  the  intervention 

of 

a  notified 

body, 

the  manufacturer, 

or 

his 

authorized 

representative  established  in  the  Community,  may  apply  to  a  body  of 

his  choice  within  the  framework  of  the  tasks  for  which  the  body  has 

been  not i f ied. 

9. 

Decisions  taken  by  the  notified  bodies  in  accordance  with  Annexes  2 

and  3 shall  be  valid  for  a maximum  of  five  years  and  may  be  extended 

on  application  for  further  periods  of  five  years. 

10. 

The  records  and  correspondence  relating  to  the  procedures  referred 

to  in  paragraphs  1  to  5  shall  be  in  an  official  language  of  the 

Member  State  in  which  the  procedures  are  carried  out  or  in  a 

language  acceptable  to  the  notified  body. 

-  34  -

Art icle  12 

Assembly  and  sterilization 

Any  natural  or  legal  person  who  assembles  devices  bearing  the  EC 

mark  for  their  intended  purpose  and  within  the  limits  of  use 

specified  by  their  manufacturers  with  regard  to  their  compatibility 

with  other  devices  in order  to  put  them  on  the  market  in  the  form  of 

a  system,  kit  or  operation  pack  shall  draw  up  a  declaration  in which 

he  states  that: 

(a) 

he  has  verified  the  mutual  compatibility  of  the  devices  which 

make  up  the  system,  kit  or  operation  pack  in  accordance  with 

the  manufacturers'  instructions  and  that  assembly  has  been 

carried  out  in accordance  with  these  instructions; 

(b) 

the  system,  kit  or  operation  pack  has,  where  applicable,  been 

packaged  in accordance  with  the manufacturers'  instructions  or 

the  limits  applicable  to  the  various  devices; 

(c) 

all  of  the  activities  referred  to  in  (a) and  (b) are  subjected 

to  appropriate  methods  of  control  and  inspection. 

Any  such  system,  kit  or  operation  pack  shall  not  bear  any  additional 

EC  mark.  It  shall  be  accompanied  by  the  information  referred  to  in 

point 

13  of  Annex  1  which 

includes,  where  appropriate,  the 

information  supplied  by  the  manufacturers  of  the  devices  which  have 

been  assembled. 

Any  natural  or  legal  person  who,  in  the  framework  of  an  activity 

referred  to  paragraph  1,  sterilizes  devices  bearing  the  EC  mark, 

shall,  at  his  choice,  follow  one  of  the  procedures  referred  to  in 

Annex  4 or  5.  The  application  of  the  abovementioned  Annexes  and  the 

intervention  of  the  notified  body  are  limited  to  the  aspects  of  the 

procedure  relating  to  the  obtaining  of  sterility.  The  person  shall 

draw  up  a  declaration  stating  that  sterilization  has  been  carried 

out  in accordance  with  the manufacturer's  instructions. 

(6) 

-  35  -

3. 

This Article does not  apply  if one of  the devices concerned  does not 

bear  the  EC mark  or  if the  EC mark  for  one of  the  devices  has been 

affixed  for a different  intended purpose. 

Article 13 

Decisions with  regard  to classification, derogation clause 

1. 

Where  a Member  State considers that 

(a)  application  of  the  classification  rules  set  out  in  Annex  9 

requires  a  decision  with  regard  to  the  classification  of  a 

given device or  family of devices, or 

(b)  a given  device  or  family  of  devices  should  be  classified,  by 

way  of  derogation  from  the  provisions  of  Annex  9,  in another 

class, or 

(c)  the  conformity  of  a  device  or  family  of  devices  should  be 

established,  by  way  of  derogation  from  the  provisions  of 

Article  11,  by  applying  solely  one  of  the  given  procedures 

chosen  from among  those referred  to  in Article 11, 

it  shall  submit  a duly  substantiated  request  to  the  Commission  and 

ask  it  to  take  the  necessary  measures.  Where  appropriate,  these 

measures  shall  be  adopted  in accordance  with  the procedure  referred 

to  in Article 7(2). 

2. 

The  Commission  shall  inform  the Member  States of  the measures  taken 

and, where appropriate, publish  the relevant  parts of  these measures 

in the Official  Journal  of  the European  Communities. 

-  36  -

Article  14 

Registration  of  persons  responsible  for  placing  devices  on  the  market 

1. 

Any  manufacturer  who,  on  his  own  behalf,  places  devices  on  the 

market 

in  accordance  with 

the  procedures 

referred 

to 

in 

Article  11(4)  and  (5)  shall  inform  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  and  the  category  of 

devices  concerned. 

2. 

Where  a  manufacturer  who  places  devices  referred  to  in  paragraph 1 

on  the  market  on  his  own  behalf  does  not  have  a  registered  place  of 

business  in  a  Member  State,  he  shall  designate  the  person(s) 

responsible  for  marketing  them  and  established  in  the  Community. 

These  persons  shall 

inform  the  competent  authorities  of  the 

Member  State  in  which  they  have  their  registered  place  of  business 

of  the  address  of  the  registered  place  of  business  and  the  category 

of  devices  concerned. 

3. 

The  Member  States  shall  on  request  inform  the  other  Member  States 

and  the  Commission  of  the  details  referred  to  in paragraphs  1 and  2. 

Art icle  15 

Clinical  investigation 

1. 

In  the  case  of  devices  falling  within  Classes  I,  Ma  and  Mb  which 

are  intended  for  clinical  investigations,  the  manufacturer,  or  his 

authorized  representative  established  in the  Community,  shall  follow 

the  procedure  referred  to  in  Annex  8  and  keep  the  statement 

concerned  at  the  disposal  of  the  competent  authorities. 

2. 

In  the  case  of  devices  falling  within  Class  III  and  implantable 

devices  falling  within  Classes  Ma  or  Mb  intended  for  clinical 

investigations,  the  manufacturer,  or  his  authorized  representative 

established  in  the  Community,  shall  follow  the  procedure  referred  to 

in  Annex  8  and,  at  least  45  days  before  the  commencement  of  the 

investigations, 

submit 

the 

statement 

referred 

to 

in 

the 

abovementioned 

Annex 

to 

the 

competent 

authorities 

of 

the 

Member  State  in which  the  investigations  are  to  be  conducted. 

-  37  -

The  manufacturer  may  commence  the  relevant  clinical  investigations 

at  the  end  of  a  period  of  45  days  after  notification,  unless  the 

competent  authorities  have  notified  him  within  that  period  of  a 

decision  to  the  contrary  based  on  considerations of  public  health  or 

pub Iic  order. 

3. 

The  clinical  investigations must  be  conducted  in conformity  with  the 

provisions  of  Annex  10.  The  provisions  of  Annex  10  shall  be 

adjusted  in accordance  with  the  procedure  laid  down  in Article 7 ( 2 ). 

4. 

The  Member  States  shall,  if necessary,  take  the  appropriate  steps  to 

ensure  public  health  and  public  order. 

5. 

The  manufacturer  or  his  authorized  representative  established  in  the 

Community  shall  keep  the  report  referred  to  in  point  2.3.7  of 

Annex  10 at  the  disposal  of  the  competent  authorities. 

6. 

The  provisions  of  paragraphs  1 and  2 do  not  apply  where  the  clinical 

investigations  are  conducted  using  devices  which  are  authorized  in 

accordance  with  Article  11  to  bear  the  EC  mark  unless  the  aim  of 

these  investigations  is  to  use  the  devices  for  a  purpose  other  than 

that  referred  to  in  the  relevant  conformity  assessment  procedure. 

The  relevant  provisions  of  Annex  10  remain  applicable. 

Article  16 

Not if led  bodies 

1. 

The  Member  States  shall  notify  the  other  Member  States  and  the 

Commission  of  the  bodies  which  they  have  designated  for  carrying  out 

the  tasks  pertaining  to  the  procedures  referred  to  in  Articles  11 

and  18  and  the  specific  tasks  for  which  the  bodies  have  been 

designated.  In  this  Directive,  these  bodies  are  referred  to  as 

"not ified  bodies". 

The  Commission  shall  allocate  an  identification  number  to  these 

bodies  and  inform  them  and  the  Member  States  of  it.  It  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. 

38  -

2. 

Member  States  shall  apply  the  minimum  criteria  set  out  in  Annex  11 

for  the  designation  of  bodies.  Bodies  that  meet  the  criteria  laid 

down  in  the  relevant  harmonized  standards  shall  be  presumed  to  meet 

the  relevant  minimum  criteria. 

3. 

A  Member  State  that  has  notified  a  body  shall  withdraw  that 

notification  if  it  finds  that  the  body  no  longer  meets  the  criteria 

referred  to  in  paragraph  2.  It  shall  immediately  inform  the  other 

Member  States  and  the  Commission  thereof. 

4. 

The  notified 

body  and 

the  manufacturer,  or 

his 

authorized 

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  2  to  6. 

Article  17 

EC  marking 

1. 

Devices,  other  than  devices  which  are  custom-made  or  intended  for 

clinical 

investigations, 

considered 

to 

meet 

the 

essential 

requirements  referred  to  in  Article  3  must  bear  the  EC  mark  of 

conformity  when  they  are  placed  on  the  market. 

2. 

The  EC  mark  of  conformity,  as  shown  in  Annex  12,  must  appear  in  a 

visible,  legible  and  indelible  form  on  the  device,  where  practicable 

and  appropriate,  and/or  on  the  sales  packaging  and  the  instruction 

leaflet. 

It  shall  be  accompanied  by  the  identification  number  of  the  notified 

body  responsible  for  implementation  of  the  procedures  set  out  in 

Annexes  2,  4,  5  and  6  and  the  last  two  digits  of  the  year  in  which 

the  mark  was  affixed. 

3. 

In  the  event  of  a  significant  change  in  the  intended  purpose  of  a 

device,  the  EC  mark  may  be  affixed  only  if  the  manufacturer  or, 

where  appropriate,  his  authorized  representative  established  in  the 

Community,  has  followed  the  applicable  procedures  in accordance  with 

Article  11. 

4. 

It  is  prohibited  to  affix  marks  which  may  be  confused  with  the  EC 

mark  of  conformity. 

-  39  -

Article  18 

Obligations  of  the  notified  body  in  the  case  of  a wrongly  affixed  mark 

Where  it  is  found  that  the  EC  mark  has  been  wrongly  affixed,  the  notified 

body  which  carried  out  the  assessment  of  conformity  shall  take  appropriate 

measures  and  forthwith  inform  the  competent  Member  State  thereof.  The 

competent  Member  State  shall  inform  the  other  Member  States  and  the 

Commission  thereof. 

Article  19 

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  the  putting 

into  service  of  a  device  or  the  carrying  out  of  clinical 

investigations,  or 

(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  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  to withdraw  devices  from  the  market,  the 

manufacturer,  or  his  authorized  representative  established  in  the 

Community,  shall  have  an  opportunity  to put  forward  his  viewpoint  in 

advance,  unless  such  consultation  is  not  possible  because  of  the 

urgency  of  the  measure  to  be  taken. 

-  40  -

Article 20 

Confident iality 

Without  prejudice  to  the  existing  national  provisions  and  practices  on 

medical  secrets,  Member  States  shall  ensure  that  all  the  parties  involved 

in  the  application  of  this  Directive  are  bound  to observe  confidentiality 

with  regard  to all  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. 

Article 21 

Guide!ines 

The  Commission  shall  adopt  the  necessary  guidelines  for  the  uniform 

application of  this Directive  in respect  in particular  of: 

(a)  the scope of  the Directive, 

(b)  the classification of devices, 

(c)  the conformity  assessment  procedures. 

The  Commission  shall  publish  these  guidelines  in  the  Official  Journal  of 

the European  Communities. 

Article 22 

Repeal  and amendment  of Directives 

1. 

Directive  76/764/EEC 

is  hereby  repealed  with  effect 

from 

1 July 1994. 

2. 

In  the  title  and  Article  1  of  Directive  84/539/EEC,  the  words 

"human or" are  deleted. 

-  41  -

3. 

The 

following 

paragraph 

6 

is 

added 

to 

Article  1 

of 

Directive  90/385/EEC: 

"6.  The 

following 

provisions 

of 

Council 

Directive 

../.../EEC^2 6)  [on  medical 

devices]  also  apply 

to 

active 

implantable 

medical 

devices:  Article  1(2)(g) 

and  ( i );  Article  11(6),  (8) and  ( 9 ); Article  13(1)(c) 

coupled  with  Article  7;  Article  17(3);  Article  19(2); 

Article  21  points  (a) and  (c) of  the  first  paragraph." 

Art icle  23 

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  31  December  1993.  They  shall  immediately  inform  the 

Commission  thereof. 

The  standing  committee  referred  to  in  Article  7  may  assume  its 

tasks  from  the  date  of  notification  of  this  Directive.  The  Member 

States  may  take  the  measures  referred  to  in  Article  16  within  six 

months  of  notification  of  this  Directive. 

When  Member  States  adopt  these  provisions,  these  shall  contain  a 

reference  to  this  Directive  or  shall  be  accompanied  by  such  a 

reference 

at 

the 

time 

of 

their  official 

publication.  The 

procedure  for  such  reference  shall  be  adopted  by  Member  States. 

Member  States  shall 

apply  these  provisions  with  effect 

from 

1  July  1994. 

2. 

Member  States  shall  communicate  to  the  Commission  the  texts  of  the 

provisions  of  national  law  which  they  adopt  in  the  field  covered  by 

this  Direct ive. 

(26) 

-  42  -

3. 

Member  States  shall  take  the  necessary  action  to  ensure  that  the 

notified  bodies  which  are  responsible  pursuant  to  Article  11(1)  to 

(4)  for  the  assessment  of  the  conformity  of  devices  already  placed 

on  the  market  prior  to  the  implementation  of  this  Directive  take 

account  of  the  results  of  tests  and  verifications  already  carried 

out  under  pre-existing  national  law  in  respect  of  such  devices  and 

of  any  other  relevant  information  regarding  the  characteristics  and 

performance  of  such  devices. 

4. 

In  the  case  of  devices  which,  for  the  purposes  of  this  Directive, 

must  be  the  subject  of  one  of  the  procedures  referred  to  in  Annexes 

2  to  6,  Member  States  shall  accept  the  placing  on  the  market  and 

putting  into  service  of  devices  which  conform  to  the  rules  in  force 

in  their  territory  on  30  June  1994  during  the  period  up  to 

30  June  1997.  In  the  case  of  other  devices  lawfully  placed  on  the 

market  before  30  June  1994,  Member  States  shall  accept  their  being 

put  into  service  during  the  period  up  to  30  June  1995. 

In  the  case  of  devices  which  have  been  subjected  to  EEC  pattern 

approval  in  accordance  with  Directive  76/764/EEC,  Member  States 

shall  accept  their  being  placed  on  the  market  and  put  into  service 

during  the  period  up  to  30  June  2004. 

Article  24 

This  Directive  is addressed  to  the Member  States. 

Done  at  Brussels, 

For  the  Council 

The  President 

(7) 

-  43  -

ANNEX 1 

ESSENTIAL REQUIREMENTS 

>•  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  the  clinical  condition  or  the  safety  of  the 

patients,  users  and,  where  applicable,  other  persons.  The  risks 

associated  with  the  devices must  be  reduced  to  an  acceptable  level 

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. 

3. 

The  devices  must  achieve  the  performances  intended  by  the 

manufacturer,  i.e.  be  designed  and  manufactured  in such  a way  that 

they  are  suitable  for  one  or  more  of  the  functions  referred  to  in 

Article  1(2)(a), as specified  by the manufacturer. 

4. 

The characteristics and performances  referred  to  in Sections 1 and 3 

must  not  be  adversely  affected  to such  a  degree  that  the  clinical 

condition and safety of  the patients 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. 

5. 

The  devices must  be designed, manufactured  and  packed  in such  a way 

that  their  characteristics  and  performances  during  their  intended 

use  are  not  adversely  affected  in  the  storage  and  transport 

conditions  (temperature,  humidity,  etc.)  laid  down  by  the 

manufacturer. 

6. 

Any  undesirable  side-effects  must  constitute  acceptable  risks  when 

weighed  against  the performances  intended. 

II.  Requirements regarding  design and  construction 

-  44  -

7. 

Chemical  and  Physical  properties 

7.1 

The  devices  must  be  designed  and  manufactured  in  such  a  way  as  to 

guarantee  the  characteristics  and  performances  referred  to  in 

Section  I on  the  "General  requirements".  Particular  attention  must 

be paid to: 

the choice of materials used, particularly  as regards  toxicity 

and, where  appropriate, flammabiIity; 

the  compatibility  between  the  materials  used  and  biological 

tissues, cells and body  fluids, taking  account  of  the  intended 

purpose of  the device. 

7.2 

The  devices must  be  designed, manufactured  and  packed  in such  a way 

as  to  minimize  the  risk  posed  by  contaminants  and  residues  to  the 

persons  involved  in  the  transport,  storage  and  use  of  the  devices 

and  to  the  patients,  taking  account  of  the  intended  purpose  of  the 

product.  Particular  attention  must  be  paid  to  the  tissues  exposed 

and  to the duration  and  frequency of exposure. 

7.3 

The  devices  must  be  designed  and  manufactured  in  such  a  way  that 

they  can  be  used  completely  safely  with  the  materials,  substances 

and  gases  with  which  they  enter  into  contact  during  normal  use  or 

routine  treatment. 

7.4 

Where a device  incorporates, as an  integral  part, a substance  which, 

if used  separately, may  be considered  to be  a medicinal  product, as 

defined  in  Article  1  of  Directive 65/65/EEC,  and  whose  action  in 

combination  with  the  device  can  result  in  its  bioavailability,  the 

safety,  quality  and  usefulness  of  the  substance  must  be  verified, 

taking  account  of  the  intended  purpose  of  the  device,  by  analogy 

with  the  appropriate  methods  specified  in  Directive  75/318/EEC,  as 

last amended  by Directive 89/341/EEC. 

7.5 

The  devices  must  be  designed  and  manufactured  in  such  a  way  as  to 

minimize  the  health  risks  posed  by  substances  leaking  from  the 

device dur ing use. 

8. 

Infection  and  microbial  contamination 

-  45  -

8.1 

The  devices  and  manufacturing  processes  must  be  designed  in  such  a 

way  as  to minimize  the  risk  of  infection  to  the  patient.  The  design 

must 

allow 

easy 

handling 

and, 

where 

necessary, 

minimize 

contamination  of  the  device  by  the  patient  or  vice  versa  during  use. 

8.2 

Where  a  device  incorporates  animal  or  human  tissues,  the  risks  of 

cross-infect ion  must  be  minimized  by  selecting  appropriate  tissues 

and 

using 

appropriate 

inactivation, 

conservation 

and 

test 

procedures. 

8.3 

Sterile  devices  must  be  designed,  manufactured  and  packed  in  a 

non-reusable  pack  and/or  according  to  appropriate  procedures  to 

ensure  that  they  are  sterile  when  placed  on  the  market  and  remain 

sterile,  under  the  storage  and  transport  conditions  laid  down,  until 

the  protective  packaging  is damaged  or  opened. 

8.4 

Devices 

labelled  sterile  must 

have  been  sterilized 

by  an 

appropriate,  validated  method. 

8.5 

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  sterilized  prior  to use,  minimize  the  risk  of 

microbial  contamination. 

8.6 

The  packs  and/or  label  of  the  device  must  distinguish  between 

identical  or  similar  products  sold  in  both  sterile  and  non-sterile 

packaging. 

9. 

Construction  and  environmental  properties 

9.1 

If  the  device  is  intended  for  use  in combination  with  other  devices 

or  equipment,  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  or  in  the  instruction  leaflet. 

9.2 

Devices must  be designed  and manufactured  in such a way  as to remove 

or minimize as far as possible: 

-  46  -

the  risk  of  injury,  in  connection  with  their  physical, 

including dimensional  features; 

risks  connected  with  reasonably  foreseeable  environmental 

conditions,  such  as  magnetic  fields,  external  electrical 

influences, electrostatic discharge, pressure or variations  in 

pressure and acceleration; 

the risks of  interference with other  devices normally  required 

for  the  investigations or  for  the treatment  given; 

risks  possibly  arising  from  lack  of  maintenance  and 

calibration,  including: 

ageing of  the materials used, 

loss of accuracy of any measuring or control  mechanism. 

9.3 

Devices  must  be  designed  and  manufactured  in  such  a  way  as  to 

minimize  the  risks  of  fire  or  explosion  during  normal  use  and  in 

failsafe  condition.  Particular  attention  must  be  paid  to  devices 

which  must  be  exposed  to  or  used  in  association  with  flammable 

substances or substances which could cause combustion. 

10. 

Devices with  a measuring  function 

10.1 

Devices with  a measuring  function must  be designed  and  manufactured 

in  such  a  way  as  to  provide  sufficient  accuracy  and  stability  as 

specified  by  the  manufacturer,  taking  account  of  the  intended 

purpose of  the device. 

10.2  The  units  on  the measurement,  monitoring  and  display  scale  must  be 

designed  in  line  with  ergonomie  principles,  taking  account  of  the 

intended  purpose of  the device. 

10.3  The  measurements  made  by  devices  with  a measuring  function  must  be 

expressed  in  legal  units  conforming  to  the  provisions  of  Council 

Directive 80/181/EEC(1), 

as 

last 

amended 

by 

Directive 

89/617/EEC<2>. 

(1)  OJ No L 39, 15.2.1980, p. 40. 
(2)  OJ  No L 357, 7.12.1989, p. 28. 

11. 

Protection  against  radiât Ion 

_  47  -

11.1 

The  devices  must  be  designed  and  constructed  in such  a way  that  the 

radiation  emitted  will  not  attain  dangerous  levels.  Where  emission 

of  dangerous  levels of  radiation  is necessary  for  a specific  medical 

purpose  considered  to outweigh  the  risks  inherent  in  the  emissions, 

it must  be possible  for  the user  to control  the emissions. 

11.2 

Devices  emitting  ionizing  radiation must  be designed  and  constructed 

in such  a way  as: 

(a) 

to  ensure  that  the  quantity  and  quality  of  radiation  emitted 

can  be adjusted  and  controlled; 

(b) 

to  reduce  exposure  of  the  user  at  work  and  all  unnecessary 

exposure of  the  patient. 

11.3 

The  operating  instructions  for  devices  emitting  radiation  must  give 

detailed  information  on  the  nature  of  the  devices,  means  of 

protecting  the  patient  and  user  and  on  ways  of  avoiding  mishandling 

and  the  risks  inherent  in  installation. 

11.4 

Devices  emitting  radiation  must  be designed  and manufactured  in such 

a  way  as  to  reduce  unnecessary  exposure  of  the  patient  and  of  the 

user  as  far  as possible. 

11.5 

Instruments,  apparatus  or  appliances  emitting  radiation  must  be 

fitted  with  visual  displays  and/or  audible  warnings  of  radiation 

emissions. 

12- 

Requirements  for  medical  devices  connected  to  or  equipped  with  an 

energy  source 

12.1 

Devices  depending  on  software  must  be  designed  in  such  a way  as  to 

minimize  the  risks arising  from errors  in the  program. 

12.2 

Devices  where  the  safety  of  the  patients  depends  on  an  internal 

power  supply  must  be  equipped  with  a means  of  determining  the  state 

of  the power  supply. 

-  48 -

12.3  Devices  where  the  safety  of  the  patients  depends  on  an  external 

power  supply  must  include  an  alarm  system  to  signal  any  power 

failure. 

12.4  Devices  intended  to  monitor  one  or  more  clinical  parameters  of  a 

patient  shall  be  equipped  with  appropriate  alarm  systems  to  alert 

the  user  of  situations  which  could  lead  to  death  or  severe 

deterioration of  the patient's state of health. 

12.5  The  devices  must  be  designed  and  manufactured  in such  a way  as  to 

minimize  the  risks  of  creating  electromagnetic  fields  which  could 

impair  the operation of other  devices or equipment  in the vicinity. 

12-6  Protection  against  electrical  risks 

The  devices  must  be  designed  and  manufactured  in such  a way  as  to 

avoid, as far as possible, the risk of electric shocks during normal 

use  and 

n  single  fault  condition,  provided  the  devices  are 

installed correctly. 

12.7  Protection  against  mechanical  and  thermal  risks 

12.7.1  The  devices  must  be  designed  and  manufactured  in  such  a way  as  to 

protect  the  patient  and  user  against  mechanical  risks  connected 

with, for example, resistance, stability  and moving parts. 

12.7.2 The  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. 

12.7.3 The  devices  must  be  designed  and  manufactured  in such  a  way  as  to 

reduce  to the  lowest  possible  level  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. 

-  49  -

12.7.4 The  terminals  and  connectors  to  the  electricity,  gas  or  hydraulic 

and  pneumatic  energy  supplies  which  the  user  has  to  handle  must  be 

designed  and  constructed  in  such  a  way  as  to  minimize  all  possible 

risks. 

12.7.5 Accessible  parts  of  the  devices  and  their  surroundings  must  not 

attain  potentially  dangerous  temperatures  under  normal  use. 

12.8 

Protection  against  the  risks  posed  to  the  patient  by  energy  supplies 

or  substances 

12.8.1  Devices  for  supplying  the  patient  with  energy  or  substances  must  be 

designed  and  constructed  in such  a way  that  the  flow  rate  can  be  set 

and  maintained  accurately  enough  to  guarantee  the  safety  of  the 

patient  and  of  the  user. 

12.8.2  Devices  must  be  fitted  with  an  interlock  and/or  alarm  system  to 

prevent  and/or  indicate  any  inadequacies  in  the  flow  rate  which 

could  pose  a  danger. 

12.9 

The  function  of  the  controls  and  visual  displays  must  be  clearly 

specified  on  the  devices. 

13. 

Information  supplied  by  the  manufacturer 

13.1 

Each  device  must  be  accompanied  by  the  information  needed  to  use  it 

safely  and  to  identify  the  manufacturer,  taking  account  of  the 

training  and  knowledge  of  the  potential  users. 

This  information  comprises  the  details  on  the  label  and  the  data  in 

the  instruction  leaflet. 

As  far  as  practicable  and  appropriate,  the  information  needed  to  use 

the  device  safely  must  be  set  out  on  the  device  itself  and/or  on  the 

packaging  for  each  unit  or,  where  appropriate,  on  the  sales 

packaging.  If  individual  packaging  of  each  unit  is not  practicable, 

the  information  must  be  set  out  in  the  leaflet  supplied  with  one  or 

more  devices. 

-  50  -

An  instruction  leaflet  must  be  included  in the  packaging  for  every 

device. 

By  way  of  exception,  no  such  instruction  leaflet  is  needed  for 

devices  in  Class  I  or  Class  Ma  if  they  can  be  used  completely 

safely without  any such  instructions. 

13.2  Where appropriate, this  information should  take the form of  symbols. 

Any  symbols  and  identification  colours  used  must  conform  to  the 

harmonized  standards.  In  areas  for  which  no  standards  exist,  the 

symbols  and  colours must  be described  in the documentation  supplied 

with  the device. 

13.3  The  label must  bear  the following  particulars: 

(a)  the name or  trade name and address of  the manufacturer; 

(b)  the  details  strictly  necessary  for  the  user  to  identify  the 

device and  the contents of  the packaging-, 

(c)  where appropriate, the word  "STERILE"; 

(d)  where appropriate, the batch code, preceded  by  the word  "LOT", 

or  the serial  number; 

(e)  where  appropriate,  an  indication  of  the  time  limit  for 

completely  safe use, expressed  as the year  and month; 

(f)  where appropriate, an  indication that  the device  is for  single 

use; 

(g) 

if the device  is custom-made, the words  "custom-made device"; 

(h) 

if  the  device  is  intended  for  clinical  investigations,  the 

words  "exclusively  for clinical  investigations"; 

(i)  any special  storage and/or  handling conditions; 

(j)  any special  operating  instructions; 

(k)  any warnings and/or  precautions to take. 

(8) 

-  51  -

13.4 

If  the  intended  purpose  of  the  device  is not  obvious  to  the  user, 

the  manufacturer  must  clearly  state  it  on  the  label  and  in  the 

instruction  leaflet. 

13.5  Wherever  reasonable  and  practicable,  the  devices  and  detachable 

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. 

13.6  Where  appropriate,  the  instruction  leaflet  must  contain  the 

following particulars: 

(a)  for  devices 

in  Class  Mb  or  Class  III  the  year  of 

authorization  to affix  the EC mark; 

(b)  the details  referred  to  in Section  13.3, with  the exception of 

points  (d) and (e); 

(c)  the  performances  referred  to  in Section  3 and  any  undesirable 

side-effects; 

(d) 

if  the  device  must  be  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 combination; 

(e)  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  needed 

to ensure  that  the devices operate  properly  and  safely  at all 

t imes-, 

(f)  where  appropriate,  information  to  avoid  certain  risks  in 

connection with  implantation of  the device-, 

(g) 

information  regarding  the  risks  of  reciprocal  interference 

posed  by  the  presence  of  the  device  during  specific 

investigations or  treatment; 

-  52  -

(h) 

the  necessary  Instructions  in  the  event  of  damage  to  the 

sterile 

packaging 

and, 

where 

appropriate, 

details 

of 

appropriate  methods  of  resteriIization; 

(I) 

if  the  device  is  reusable,  information  on  the  appropriate 

processes  to  allow  reuse,  including  cleaning,  disinfection, 

packaging  and,  where  appropriate,  resteriMzation,  and  any 

restriction  on  the  number  of  reuses; 

(J) 

details  of  any  further  treatment  or  handling  needed  before  the 

device  can  be  used  (for  example,  sterilization,  final 

assembly,  etc.); 

(k) 

in  the  case  of  devices  emitting  radiation  for  medical 

purposes,  details  of 

the  nature,  type, 

intensity 

and 

distribution  of  this  radiation. 

The  instruction  leaflet  must  also  include  details  allowing  the 

medical  staff  to  brief  the  patient  on  any  contra-indications 

and  any  precautions  to  be  taken.  These  details  should  cover 

in part icular: 

(I) 

precautions  to  be  taken  in  the  event  of  changes  in  the 

performance  of  the  device; 

(m) 

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.; 

(n) 

adequate  information  regarding  the  medicinal  products  which 

the  device  in question  is designed  to  administer; 

(o) 

precautions  to  be  taken  against  any  special,  unusual  risks 

related  to  the  disposal  of  the  device. 

-  53  -

ANNEX  2 

EÇ pEgARATIQN QF CQNFQRMITY 

(FUU, QUAIITY ASSURANCE SYSTEM) 

1. 

The  manufacturer  shall  apply  the  quality  system  approved  for  the 

design,  manufacture  and  final  inspection  of  the  products  concerned, 

as  specified  in  Sections  3  and  4,  and  shall  be  subject  to  the  EC 

surveillance  specified  in Section  5. 

2. 

The  declaration  of  conformity 

is  the  procedure  whereby  the 

manufacturer  who  fulfils  the  obligations  imposed  by  Section  1 

ensures  and  declares  that  the  products  concerned  meet  the  provisions 

of  this  Directive  which  apply  to  them. 

The  manufacturer  shall  affix  the  EC  mark  in  accordance  with 

Article  17  and  shall  draw  up  a  written  declaration  of  conformity. 

This  declaration  shall  cover  a given  number  of  identified  specimens 

of  the  products  manufactured  and  shall  be  kept  by  the  manufacturer. 

The  EC mark  shall  be  accompanied  by  the  identification  number  of  the 

notified  body  which  performs  the  tasks  referred  to  in this  Annex. 

3. 

Qua Iity  system 

3.1 

The  manufacturer  shall  lodge  an  application  for  assessment  of  his 

quality  system  with  a notified  body. 

The  application  shall  include: 

the  name  and  address  of  the  manufacturer; 

all  the  relevant  information  on  the  product  or  product 

category  covered  by  the  procedure; 

a written  declaration  that  no  application  has  been  lodged  with 

any  other  notified  body  for  the  same  products; 

the  documentation  on  the quality  system-, 

an  undertaking  to  fulfil  the  obligations  imposed  by  the 

quality  system  approved; 

an  undertaking  to  keep  the  approved  quality  system  adequate 

and  ef f icacious-, 

-  54  -

an  undertaking  by  the  manufacturer  to  institute  and  keep 

updated 

a 

post-marketing 

surveillance 

system.  This 

undertaking  shall  include  an  obligation  for  the  manufacturer 

to notify  the competent  authorities of  the following  incidents 

immediately  on  learning of  them: 

(i) any 

deterioration 

in  the  characteristics 

and/or 

performances of  a device, as well  as any  inaccuracies  in 

the  instruction  leaflet which might  lead  to or might  have 

led  to  the  death  of  a  patient  or  user  or  to  a  serious 

deterioration  in their  state of health-, 

(ii) any  technical  or medical  reason connected with  the device 

leading  to  recall  of  devices  of  the  same  type  by  the 

manufacturer. 

3.2 

Application  of  the  quality  system  must  ensure  that  the  products 

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  shall  be  documented  in  a  systematic  and  orderly 

manner  in the form of written  policies and procedures.  This quality 

system  documentation  must  permit  uniform  interpretation  of  the 

quality  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 organization of  the business and  in particular: 

the  organizational  structures,  the  responsibilities  of 

the  managerial  staff  and  their  organizational  authority 

where  quality  of  design  and  manufacture  of  the  products 

is concerned; 

-  55  -

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  products  which  fail  to  conform; 

(c) 

the  procedures  for  monitoring  and  verifying  the  design  of  the 

products  and  in  particular: 

a  general  description  of  the  product,  including  any 

var iants  planned; 

the  design  specifications,  including  the  standards  which 

will  be  applied  and  a  description  of  the  solutions 

adopted  to  fulfil  the  essential  requirements  which  apply 

to  the  products  if  the  standards  referred  to  in Article  5 

are  not  applied  in  fui I ; 

the  techniques  used  to  control  and  verify  the  design  and 

the  processes  and  systematic  measures  which  will  be  used 

when  the  products  are  being  designed; 

if  the  device  is  to  be  connected  to  other  device(s)  in 

order  to operate  as  intended,  proof  must  be  provided  that 

it  conforms  to  the  essential  requirements  when  connected 

to  any 

such 

device(s)  having 

the 

characteristics 

specified  by  the  manufacturer-, 

a  statement 

indicating  whether  or  not 

the  device 

incorporates,  as  an  integral  part,  a  substance  as 

referred  to  in  Section  7.4  of  Annex  1  whose  action  in 

combination 

with 

the 

device 

may 

result 

in 

its 

bioavailability  and  data  on  the  tests  conducted  in  this 

connect ion; 

the  clinical  data  referred  to  in Annex  10-, 

the  draft  label  and,  where  appropriate,  instruction 

leaf let ; 

-  56  -

(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  sterilization,  purchasing  and  the 

relevant  documents; 

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  of  the  test  equipment 

adequately. 

3.3 

The  notified  body  shall  audit  the  quality  system  to  determine 

whether  it  meets  the  requirements  referred  to  in  Section  3.2.  It 

shall  presume  that  quality  systems  which  implement  the  relevant 

harmonized  standards  conform  to  these  requirements. 

The  assessment  team  shall  include  at  least  one  member  with  past 

experience  of 

assessments  of 

the  technology 

concerned.  The 

assessment 

procedure 

shall 

include 

an 

inspection 

on 

the 

manufacturer's  premises  and,  in  duly  substantiated  cases,  on  the 

premises 

of 

the 

manufacturer's 

suppliers 

to 

inspect 

the 

manufacturing  processes. 

The  decision  shall  be  notified  to  the  manufacturer.  It  shall 

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. 

-  57  -

The  notified  body  shall  assess  the  changes  proposed  and  shall  verify 

whether  after  these  changes  the  quality  system  will  still  meet  the 

requirements  referred  to  in  Section  3.2.  It  shall  notify  the 

manufacturer  of  its  decision.  This  decision  shall  contain  the 

conclusions  of  the  inspection  and  a  reasoned  assessment. 

4. 

Examination  of  the  design  of  the  product 

4.1 

In  addition 

to  the  obligations 

imposed 

by 

Section  3,  the 

manufacturer  shall  lodge  an  application  for  examination  of  the 

design  dossier  relating  to  the  product  which  he  plans  to  manufacture 

and  which  falls  into  the  category  referred  to  in Section  3.1. 

4.2 

The  application  shall 

describe 

the  design,  manufacture 

and 

performances  of  the  product  in  question.  It  shall  include  the 

documents  needed  to  assess  whether  the  product  conforms  to  the 

requirements  of  this  Directive,  as  referred  to  in Section  3.2(c). 

4.3 

The  notified  body  shall  examine  the  application  and,  if  the  product 

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 

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. 

4.4 

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. 

5. 

Surveillance 

-  58  -

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  shall  authorize  the notified  body  to carry  out  all 

the  necessary  inspections  and  shall  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,  calculations, 

tests, etc.; 

the data stipulated  in the part of  the quality system  relating 

to manufacture, such as reports concerning  inspections, tests, 

calibration  and  the  qualifications  of  the  staff  concerned, 

etc. 

5.3 

The  notified  body  shall  periodically  carry  out  appropriate 

inspections  and  assessments  to  make  sure  that  the  manufacturer 

applies  the  approved  quality  system  and  shall  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  shall  provide  the 

manufacturer  with  an  inspection  report  and,  if  a  test  has  been 

carried out, with  a test  report. 

6. 

Administrative  provisions 

6.1 

The  manufacturer  shall,  for  a  period  ending  at  least  five  years 

after  the  last  product  has  been  manufactured,  keep  at  the  disposal 

of  the national  authorities: 

the declaration of  conformity; 

the  documentation  referred  to  in  the  fourth  indent  of 

Sect ion 3.1 ; 

the changes  referred  to  in Section 3.4; 

-  59  -

the documentation  referred  to  in Section  4.2;  and 

the  decisions  and  reports  from  the  notified  body  as  referred 

to  in Sections  3.3, 4.3,  4.4, 5.3  and  5.4. 

6.2 

The  notified  body  shall  communicate  to the other  notified  bodies  all 

relevant  information  concerning  the quality  system  approvals  issued, 

refused  or  withdrawn. 

7. 

A DD I icat ion  to devices  in Classes  Ma  and  Mb 

In  line with  Article  11(2) and  (3), this Annex  may  apply  to  products 

in Classes  lia and  M b,  subject  to  the  following  derogations: 

7.1 

For  products  in  Class  M a,  by  way  of  derogation  from  the  final 

indent  of  Section  3.1,  the  manufacturer  shall  undertake  to  notify 

the  competent  authorities  of  the  incidents  referred  to  in  the 

abovementioned  indent  immediately  on  learning  of  them  and  to 

institute  and  keep  updated  an  appropriate  internal  system  for  this 

purpose. 

7.2 

Section 4 shall  not  apply  to products  in Classes  Ma  and  M b. 

-  60  -

ANNEX  3 

EC  TYPE-EXAMINATION 

1. 

EC  type-examination  is  the  procedure  whereby  a  notified  body 

ascertains  and  certifies  that  a  representative  sample  of  the 

production  covered  fulfils  the  relevant  provisions  of  this 

Directive. 

2. 

The  application  for  EC  type-examination  shall  be  lodged  by  the 

manufacturer  or  by  his  authorized  representative  established  in the 

Community  with  a notified  body. 

The application shall  include: 

the  name  and  address  of  the  manufacturer  and  the  name  and 

address of  the authorized  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  product.  The  documentation 

shall  contain  the  following  items  in particular: 

a  general  description  of  the  type,  including  any  variants 

planned; 

-  61  -

design 

drawings,  methods  of  manufacture 

envisaged, 

in 

particular 

as 

regards 

sterilization, 

and 

diagrams 

of 

components,  sub-assemblies,  circuits,  etc.; 

the  descriptions  and  explanations  necessary  to  understand  the 

abovementioned  drawings  and  diagrams  and  the  operation  of  the 

product; 

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  if  the  standards  referred  to 

in Article  5  have  not  been  applied  in full; 

the  results  of  the  design  calculations,  investigations, 

technical  tests, etc.  carried  out; 

a  statement  indicating whether  or  not  the  device  incorporates, 

as  an  integral  part,  a substance  as  referred  to  in Section  7.4 

of  Annex  1  whose  action  in  combination  with  the  device  may 

result  in  its bioavailability,  and  data  on  the  tests  conducted 

in this  connect ion; 

the  clinical  data  referred  to  in Annex  10; 

the  draft  label  and, where  appropriate,  instruction  leaflet. 

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; 

- 62 -

4.2 

carry  out  or  ask  for  the  appropriate  inspections  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 connected  to other  device(s)  in order  to operate 

as  intended,  proof  must  be  provided  that  it  conforms  to  the 

essential  requirements  when  connected  to  any  such  device(s)  having 

the characteristics specified by the manufacturer-, 

4.3 

carry  out  or  ask  for  the  appropriate  inspections  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 

inspections and  tests will  be carried out. 

5. 

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  inspection,  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. 

6. 

The  applicant  shall  inform  the  notified  body  which  issued  the  EC 

type-examination  certificate  of  any  significant  change  made  to  the 

approved  product. 

Changes  to  the  approved  product  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  or  with  the  conditions  prescribed  for  use  of  the 

product.  This  new  approval  shall, where  appropriate,  take  the  form 

of a supplement  to the  initial  EC type-examination certificate. 

7. 

Administrative  provisions 

-  63  -

7.1 

Each  notified  body  shall  communicate  to  the  other  notified  bodies 

all  relevant  information  on  EC  type-examination  certificates  and 

supplements  issued,  refused  or  withdrawn. 

7.2 

Other  notified  bodies  may  obtain  a  copy  of  the  EC  type-examination 

certificates  and/or  the  supplements  thereto.  The  annexes  to  the 

certificates shall  be made  available  to the other  notified  bodies  on 

reasoned  application, after  informing  the  manufacturer. 

-  64  -

ANNEX  4 

EC VERIFICATION 

1. 

EC  verification  is  the  procedure  whereby  the  manufacturer  or  his 

authorized  representative  established  in  the  Community  ensures  and 

declares  that  the  products  which  have  been  subjected  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. 

The  manufacturer  shall  take  all  the  measures  necessary  for  the 

manufacturing  process  to  ensure  that  the  products  conform  to  the 

type  described  in  the  EC  type-examination  certificate  and  to  the 

requirements of  the Directive which apply  to them.  Before  the start 

of  manufacture,  the  manufacturer  shall  prepare  documents  defining 

the  manufacturing  process,  in  particular  as  regards  sterilization 

where  necessary,  together  with  all  the  routine,  pre-established 

provisions  to  be  implemented  to  ensure  homogeneous  production  and, 

where  appropriate,  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.  The 

manufacturer  shall  affix  the  EC mark  in accordance  with  Article  17 

and shall  draw up a declaration of  conformity. 

3. 

The  manufacturer  shall  undertake  to  institute  and  keep  updated  a 

post-marketing  surveillance  system.  This  undertaking  shall  include 

an  obligation  for  the  manufacturer  to  notify  the  competent 

authorities  of  the  following  incidents  immediately  on  learning  of 

them: 

(i)  any  deterioration  in  the  characteristics  and/or  performances 

of  a  device,  as  well  as  any  inaccuracies  in  the  instruction 

leaflet  which  might  lead  to or might  have  led  to the death of 

a patient  or user or  to a serious deterioration  in their  state 

of  health; 

-  65  -

(ii)  any  technical  or  medical  reason  connected  with  the  device 

leading  to  recall  of  devices  of  the  same  type  by  the 

manufacturer. 

4. 

The  notified  body  shall  carry  out  the  appropriate  examinations  and 

tests  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,  at  the 

choice of  the manufacturer. 

5. 

Verification by examination and  testing of every  product 

5.1 

Every  product  shall  be  examined  individually  and  the  appropriate 

tests  defined  in  the  relevant  standard(s)  referred  to  in Article 5 

or  equivalent  tests  shall  be carried  out  in order  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. 

5.2 

The  notified  body  shall  affix,  or  have  affixed,  its  identification 

number  to  each  approved  product  and  shall  draw  up  a  written 

certificate of conformity  relating  to the tests carried out. 

6. 

Statistical  verification 

6.1 

The manufacturer  shall  present  the manufactured  products  in the form 

of homogeneous batches. 

6.2 

A  random  sample  shall  be  taken  from  each  batch.  The  products which 

make  up  the  sample  shall  be  examined  individually  and  the 

appropriate  tests defined  in the relevant  standard(s) referred  to in 

Article 5 or  equivalent  tests shall  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. 

-  66  -

6.3 

Statistical  control  of  products  will  be  based  on  attributes, 

entailing  a  sampling  system  ensuring  a  limit  quality  corresponding 

to  a  probability  of  acceptance  of  5%,  with  a  non-conformity 

percentage  of  between  3  and  7%.  The  sampling  method  shall  be 

established  by  the  harmonized  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  shall  affix,  or  have 

affixed,  its  identification  number  to each  product  and  shall  draw  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  a  batch  is  rejected  the  competent  notified  body  shall  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. 

7. 

Administrative  provisions 

The  manufacturer  or  the  manufacturer's  authorized  representative 

shall,  for  a  period  ending  at  least  five  years  after  the  last 

product  has  been  manufactured,  keep  at  the  disposal  of  the  national 

author it ies: 

the  declaration  of  conformity; 

the  documentation  referred  to  in Section  2; 

the  certificates  referred  to  in Sections  5.2  and  6.4. 

8. 

Application  to  devices  in Class  Ma 

In  line  with  Article  11(2),  this  Annex  may  apply  to  products  in 

Class  M a,  subject  to  the  following  derogations: 

-  67  -

8.1 

By  way  of  derogation  from  Sections  1  and  2,  by  virtue  of  the 

declaration  of  conformity  the manufacturer  ensures  and  declares  that 

the  products  in  Class  Ma  are  manufactured  in  conformity  with  the 

technical  documentation  referred  to  in Section  3 of  Annex  7  and  meet 

the  requirements  of  this  Directive  which  apply  to  them. 

8.2 

By  way  of  derogation  from  Sections  1,  2, 5  and  6,  the  verifications 

conducted  by  the  notified  body  are  intended  to  confirm  the 

conformity  of  the  products  in  Class  Ma  with  the  technical 

documentation  referred  to  in Section  3 of  Annex  7. 

8.3 

By  way  of  derogation  from  Section  3,  the  manufacturer  or  the 

manufacturer's  authorized  representative established  in the  European 

Community  undertake  to  notify  the  competent  authorities  of  the 

incidents  referred  to  in  the  abovementioned  Section  immediately  on 

learning  of  them  and  to  institute  and  keep  updated  an  appropriate 

internal  system  for  this  purpose. 

-  68 -

ANNEX 5 

EC DECLARATION OF CONFORMITY 

(PRODUCTION QUAUTY ASSURANCE) 

1. 

The  manufacturer  shall  apply  the  quality  system  approved  for  the 

manufacture  of  the  products  concerned  and  carry  out  the  final 

inspection, as specified  in Section 3, and shall  be subject  to the 

EC surveillance referred to in Section 4. 

2. 

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  shall  affix  the  CE  mark  in  accordance  with 

Article 17 and  shall  draw up a written  declaration of conformity. 

This declaration shall cover a given number of  identified specimens 

of the products manufactured and shall be kept by the manufacturer. 

The CE mark shall be accompanied by the identification number of the 

notified body which performs the tasks referred to in this Annex. 

3- 

Qua Iitv system 

3.1 

The manufacturer  shall  lodge an application  for  assessment  of his 

quality system with a notified body. 

The application shall include: 

the name and address of the manufacturer; 

all  the  relevant  information  on  the  product  or  product 

category covered by the procedure; 

a written declaration that no application has been lodged with 

any other notified body for the same products-, 

-  69  -

the  documentation  on  the  quality  system; 

an  undertaking  to  fulfil  the  obligations  imposed  by  the 

quality  system  approved; 

an  undertaking  to  keep  the  approved  quality  system  adequate 

and  efficacious; 

where  appropriate,  the  technical  documentation  on  the  types 

approved  and  a  copy  of  the  EC  type-examination  certificates; 

an  undertaking  by  the  manufacturer  to  institute  and  keep 

updated 

a 

post-marketing 

surveillance 

system.  This 

undertaking  shall  include  an  obligation  for  the  manufacturer 

to  notify  the  competent  authorities  of  the  following  incidents 

immediately  on  learning  of  them: 

(i) any 

deterioration 

in 

the 

characteristics 

and/or 

performances  of  a  device,  as  well  as  any  inaccuracies  in 

the  instruction?leaflet  which  might  lead  to or  might  have 

led  to  the  death  of  a  patient  or  user  or  to  a  serious 

deterioration  in  their  state  of  health; 

(ii) any  technical  or  medical  reason  connected  with  the  device 

leading  to  recall  of  devices  of  the  same  type  by  the 

manufacturer. 

3.2 

Application  of  the  quality  system  must  ensure  that  the  products 

conform 

to 

the 

type  described 

in  the 

EC 

type-examination 

certificate.  AM  the  elements,  requirements  and  provisions  adopted 

by  the  manufacturer  for  his  quality  system  shall  be  documented  in a 

systematic  and  orderly  manner  in  the  form  of  written  policies  and 

procedures.  This  quality  system  documentation  must  permit  uniform 

interpretation  of  the  quality  policies  and  procedures  such  as 

quality  programmes,  quality  plans,  quality  manuals  and  quality 

records. 

It shall  include  in particular  an adequate description of: 

-  70  -

(a)  the manufacturer's  quality objectives; 

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

the  organizational  structures,  the  responsibilities  of 

the  managerial  staff  and  their  organizational  authority 

where manufacture of  the products  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 

products 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 sterilization, purchasing  and  the 

relevant  documents; 

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  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  of  the  test  equipment 

adequately. 

3.3 

The  notified  body  shall  audit  the  quality  system  to  determine 

whether  it  meets  the  requirements  referred  to  in  Section  3.2.  It 

shall  presume  that  quality  systems  which  implement  the  relevant 

harmonized  standards conform  to these requirements. 

-  71  -

The  assessment  team  shall  include  at  least  one  member  with  past 

experience  of  assessments  of  the  technology  concerned.  The 

assessment 

procedure  shall 

include  an 

inspection  on  the 

manufacturer's  premises  and,  in  duly  substantiated  cases,  on  the 

premises  of 

the  manufacturer's  suppliers  to 

inspect 

the 

manufacturing processes. 

The  decision  shall  be  notified  to  the manufacturer  after  the  final 

inspection.  It shall  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 shall  assess the changes proposed  and shall  verify 

whether  after  these  changes  the  quality  system  will  still  meet  the 

requirements  referred  to  in  Section 3.2.  After  receiving  the 

abovementioned  information  it  shall  notify  the  manufacturer  of  its 

decision.  This  decision  shall  contain  the  conclusions  of  the 

inspection and a reasoned  assessment. 

4. 

SurveiI lance 

4.1 

The  aim  of  surveillance  is  to  ensure  that  the  manufacturer  duly 

fulfils the obligations  imposed  by the approved  quality  system. 

4.2 

The manufacturer  shall  authorize  the notified  body  to carry  out  all 

the  necessary  inspections  and  shall  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 manufacture, such as reports concerning  inspections, tests, 

calibration  and  the  qualifications  of  the  staff  concerned, 

etc. 

- 72 -

4.3 

The  notified  body  shall  periodically  carry  out  appropriate 

inspections  and  assessments  to  make  sure  that  the  manufacturer 

applies  the  approved  quality  system  and  shall  supply  the 

manufacturer  with  an assessment  report. 

4.4 

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  shall  provide  the 

manufacturer  with  an  inspection  report  and,  if  a  test  has  been 

carried out, with  a test  report. 

5. 

Administrative  provisions 

5.1 

The  manufacturer  shall,  for  a  period  ending  at  least  five  years 

after  the  last  product  has  been  manufactured,  keep  at  the  disposal 

of  the national  authorities: 

the declaration of  conformity; 

the  documentation  referred  to  in  the  fourth  indent  of 

Sect ion 3.1 ; 

the changes referred  to  in Section 3.4; 

the  documentation  referred  to  in  the  seventh  indent  of 

Sect ion 3.1 -, and 

the  decisions  and  reports  from  the  notified  body  as  referred 

to  in Sections 4.3 and 4.4. 

5.2 

The notified body  shall  communicate  to the other  notified  bodies all 

relevant  information concerning  the quality system  approvals  issued, 

refused or withdrawn. 

6. 

Application  to devices  in Class  Ma 

In  line  with  Article  11(2),  this  Annex  may  apply  to  products  in 

Class  M a,  subject  to these derogations: 

- 73 -

6.1 

By way  of  derogation  from  Sections  2, 3.1  and  3.2, by  virtue of  the 

declaration of  conformity  the manufacturer  ensures and declares that 

the  products  in  Class  Ma  are  manufactured  in  conformity  with  the 

technical  documentation  referred  to  in Section 3 of Annex  7 and meet 

the requirements of  this Directive which apply  to them. 

6.2 

By  way  of  derogation  from  the  final  indent  of  Section  3.1,  the 

manufacturer  shall  undertake  to notify  the competent  authorities of 

the  incidents  referred  to  in  the  abovementioned  indent  immediately 

on  learning of  them and  to  institute and keep updated  an  appropriate 

internal  system  for  this purpose. 

-  74  -

ANNEX  6 

EC DECLARATION OF  CONFORMITY 

(PRODUCT QUALITY  ASSURANCE) 

1. 

The  manufacturer  shall  apply  the  quality  system  approved  for  the 

final  inspection  and  testing of  the product, as specified  in Section 

3,  and  shall  be  subject  to  the  surveillance  referred  to  in Section 

4. 

2. 

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  shall  affix  the  EC  mark  in  accordance  with 

Article  17  and  shall  draw  up  a  written  declaration  of  conformity. 

This  declaration  shall  cover  a given  number  of  identified  specimens 

of  the products  manufactured  and  shall  be kept  by  the manufacturer. 

The CE mark  shall  be accompanied  by  the  identification number  of  the 

notified  body which  performs  the tasks referred  to  in this Annex. 

3. 

Qua Iity system 

3.1 

The  manufacturer  shall  lodge  an  application  for  assessment  of  his 

quality  system with  a notified body. 

The application  shall  include: 

the name and address of  the manufacturer; 

all  the  relevant  information  on  the  product  or  product 

category  covered  by the procedure-, 

a written declaration  that  no application  has been  lodged with 

any other  notified body  for  the same products; 

-  75  -

the  documentation  on  the  quality  system; 

an  undertaking  to  fulfil  the  obligations  imposed  by  the 

quality  system  approved; 

an  undertaking  to  keep  the  approved  quality  system  adequate 

and  efficacious; 

where  appropriate,  the  technical  documentation  on  the  types 

approved  and  a  copy  of  the  EC  type-examination  certificates; 

an  undertaking  by  the  manufacturer  to  notify  the  competent 

authorities  of  the  following  incidents  immediately  on  learning 

of  them: 

(i)  any 

deterioration 

in 

the 

characteristics 

and/or 

performances  of  a  device,  as  well  as  any  inaccuracies  in 

the  instruction  leaflet  which  might  lead  to or  might  have 

led  to  the  death  of  a  patient  or  user  or  to  a  serious 

deterioration  in  their  state  of  health; 

(ii) any  technical  or  medical  reason  connected  with  the  device 

leading  to  recall  of  devices  of  the  same  type  by  the 

manufacturer. 

3.2 

Under  the  quality  system,  each  product  shall  be  examined  and  the 

appropriate  tests  defined  in  the  relevant  standard(s)  referred  to  in 

Article  5  or  equivalent  tests  shall  be  carried  out  to  ensure  that 

the 

products 

conform 

to 

the 

type 

described 

in 

the 

EC 

type-examination  certificate  and  fulfil  the  provisions  of  this 

Directive  which  apply  to  them.  All  the  elements,  requirements  and 

provisions  adopted  by  the  manufacturer  shall  be  documented  in  a 

systematic  and  orderly  manner  in  the  form  of  written  measures, 

procedures  and  instructions.  This  quality  system  documentation  must 

permit  uniform  interpretation  of  the  quality  programmes,  quality 

plans,  quality  manuals  and  quality  records. 

It shall  include  in particular  an adequate description of: 

-  76  -

the  quality  objectives  and  the  organizational  structure, 

responsibilities  and  powers  of  the  managerial  staff  with 

regard  to product  quality; 

the  examinations  and  tests  that  will  be  carried  out  after 

manufacture;  it  must  be  possible  to  trace  back  the 

calibration of  the test  equipment  adequately; 

the  methods  of  monitoring  the  efficient  operation  of  the 

qua Iity system; 

the  quality  records,  such  as  reports  concerning  inspections, 

tests,  calibration  and  the  qualifications  of  the  staff 

concerned, etc. 

3.3 

The  notified  body  shall  audit  the  quality  system  to  determine 

whether  it  meets  the  requirements  referred  to  in  Section  3.2.  It 

shall  presume  that  quality  systems  which  implement  the  relevant 

harmonized  standards conform  to these requirements. 

The  assessment  team  shall  include  at  least  one  member  with  past 

experience  of  assessments  of  the  technology  concerned.  The 

assessment 

procedure  shall 

include  an 

inspection  on  the 

manufacturer's  premises  and,  in  duly  substantiated  cases,  on  the 

premises  of 

the  manufacturer's  suppliers 

to 

inspect 

the 

manufacturing processes. 

The  decision  shall  be  notified  to  the  manufacturer.  It  shall 

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  shall  assess  the changes proposed  and shall  verify 

whether  after  these  changes  the  quality  system  will  still  meet  the 

requirements  referred  to  in  Section  3.2.  After  receiving  the 

abovementioned  information  it  shall  notify  the  manufacturer  of  its 

decision.  This  decision  shall  contain  the  conclusions  of  the 

inspection  and a reasoned  assessment. 

4. 

Survelllance 

-  77  -

4.1 

The  aim  of  surveillance  Is  to  ensure  that  the  manufacturer  duly 

fulfils the obligations  imposed  by the approved  quality  system. 

4.2 

The  manufacturer  shall  allow  the  notified  body  entrance  for 

inspection purposes  to the  inspection, testing and storage  locations 

and shall  supply  it with  all  relevant  information,  in particular: 

the documentation on  the quality  system; 

the technical  documentation; 

the  quality  records,  such  as  reports  concerning  inspections, 

tests,  calibration  and  the  qualifications  of  the  staff 

concerned, etc. 

4.3 

The  notified  body  shall  periodically  carry  out  appropriate 

inspections  and  assessments  to  make  sure  that  the  manufacturer 

applies  the quality  system  and shall  supply  the manufacturer  with an 

assessment  report. 

4.4 

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  and  that  the  production 

conforms  to the requirements of  the Directive which  apply  to  it.  To 

this end, an adequate  sample of  the final  products, taken on site by 

the  notified  body,  shall  be  examined  and  the  appropriate  tests 

defined  in  the  relevant  standard(s)  referred  to  in  Article  5  or 

equivalent  tests  shall  be  carried  out.  Where  one  or  more  of  the 

samples  fails  to  conform,  the  notified  body  shall  take  the 

appropriate  measures.  It  shall  provide  the  manufacturer  with  an 

inspection  report  and,  if a  test  has  been  carried  out,  with  a  test 

report. 

5. 

Administrative  provisions 

- 78 -

5.1 

The  manufacturer  shall,  for  a  period  ending  at  least  five  years 

after  the  last  product  has  been  manufactured,  keep  at  the  disposal 

of  the national  authorities: 

the declaration of conformity; 

the  documentation  referred  to  in  the  seventh  indent  of 

Section 3.1 -, 

the changes  referred  to  in Section  3.4;  and 

the  decisions  and  reports  from  the  notified  body  as  referred 

to  in the  final  indent  of  Section 3.4  and  in Sections 4.3  and 

4.4. 

5.2 

The notified body  shall  communicate  to the other  notified bodies all 

relevant  information  concerning  the quality system  approvals  issued, 

refused or withdrawn. 

6. 

Application  to devices  in Class  Ma 

In  line  with  Article  11(2),  this  Annex  may  apply  to  products  in 

Class  M a,  subject  to this derogation: 

6.1 

By way  of  derogation  from  Sections 2, 3.1  and  3.2, by  virtue of  the 

declaration of conformity  the manufacturer  ensures and declares that 

the  products  in  Class  Ma  are  manufactured  in  conformity  with  the 

technical  documentation  referred  to  in Section  3 of Annex  7 and meet 

the requirements of  this Directive which  apply  to them. 

-  79  -

ANNEX  7 

EC DECLARATION OF CONFORMITY 

1. 

The  EC  declaration  of  conformity  is  the  procedure  whereby  the 

manufacturer  or  his  authorized  representative  established  in  the 

Community  who  fulfils  the obligations  imposed  by  Section 2  and,  in 

the case of  sterile products and measuring  devices, the obligations 

imposed  by  Section 5  ensures  and  declares  that  the  products 

concerned meet  the provisions of  this Directive which apply  to them. 

The manufacturer  may affix  the CE mark  to each product  in accordance 

with  Article  17.  The  manufacturer  shall  draw  up  a  written 

declaration of conformity. 

2. 

The  manufacturer  shall  establish  the  technical  documentation 

described 

in  Section 3.  The  manufacturer  or  his  authorized 

representative  established  in  the  Community  shall  keep  this 

documentation,  including  the  declaration  of  conformity,  at  the 

disposal  of  the  national  authorities  for  inspection  purposes  for  a 

period  ending  at  least  five  years  after  the  last  product  has  been 

manufactured. 

Where neither  the manufacturer  nor his authorized representative are 

established  in the Community,  this obligation  to keep  the  technical 

documentation  available  shall  be  the  responsibility  of  the  person 

who places the product on the Community market. 

3. 

The  technical  documentation must  allow assessment  of  the  conformity 

of  the  product  with  the  requirements  of  the  Directive.  It  shall 

include  in particular: 

a  general  description  of  the  product,  including  any  variants 

planned; 

design drawings, methods of manufacture envisaged  and  diagrams 

of components, sub-assemblies, circuits, etc.; 

-  80  -

the  descriptions  and  explanations  necessary  to  understand  the 

abovementioned  drawings  and  diagrams  and  the  operation  of  the 

product ; 

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,  a  description  of  the  methods 

used; 

the  results  of  the  design  calculations  and  of  the  inspections 

carried  out,  etc.  if  the  device  is  to  be  connected  to  other 

device(s)  in  order  to  operate  as  intended,  proof  must  be 

provided  that  it  conforms  to  the  essential  requirements  when 

connected  to  any  such  device(s)  having  the  characteristics 

specified  by  the  manufacturer; 

the  test  reports  and,  where  appropriate,  clinical  data. 

4. 

The  manufacturer  shall  take  all  the  measures  necessary  for  the 

manufacturing  process  to  ensure  that  the  products  manufactured 

conform  to  the  technical  documentation  referred  to  in  Section  3  and 

to  the  requirements  of  the  Directive  which  apply  to  them. 

5. 

In  the  case  of  products  placed  on  the  market  in  sterile  condition 

and  of  measuring  devices,  the manufacturer  must  observe  not  only  the 

provisions  laid  down  in  this  Annex  but  also  one  of  the  procedures 

referred  to  in Annexes  4,  5 or  6.  Application  of  the  abovementioned 

Annexes  and  the  intervention  by  the  notified  body  shall  be  limited 

to: 

in  the  case  of  sterile  products,  only  the  aspects  of 

manufacture  concerned  with  obtaining  sterile  conditions; 

in  the  case  of  measuring  devices,  only  the  aspects  of 

manufacture  concerned  with  the  conformity  of  the  products  with 

the  metrological  requirements. 

Section  6.1  of  this  Annex  shall  apply. 

6. 

Application  to  devices  in Class  Ma 

-  81  -

In  line  with  Article  11(2),  this  Annex  may  apply  to  products  in 

Class  M a,  subject  to  this  derogation: 

6.1 

Where  this  Annex  is  applied  in  conjunction  with  the  procedure 

referred  to  in  Annex  4,  5  or  6,  the  declaration  of  conformity 

referred  to  in  Section  1  of  this  Annex  and  the  declaration  of 

conformity  referred  to  in  the  other  abovementioned  Annexes  shall 

form  a  single  declaration.  As  regards  the  declaration  based  on  this 

Annex,  the  manufacturer  shall  ensure  and  declare  that  the  product 

design  meets  the  provisions  of  this  Directive  which  apply  to  it. 

-  82  -

ANNEX  8 

STATEMENT CONCERNING DEVICES 

FOR SPECIAL PURPOSES 

1. 

For  custom-made  devices  or  for  devices  intended  for  clinical 

investigations  the  manufacturer  or  his  authorized  representative 

established  in the Community  shall  draw up  the statement  containing 

the  information stipulated  in Section 2. 

2. 

The statement  shall  contain  the following  information: 

2.1 

For custom-made devices: 

data allowing  identification of  the device  in question; 

a statement  that  the device  is intended  for exclusive use by a 

particular  patient, together with  the name of  the patient; 

the name of  the medical  specialist or other  authorized  person 

who made out  the prescription and, where  applicable, the  name 

of  the clinic  concerned; 

the  particular  features  of  the  device  as  specified  in  the 

relevant medical  prescription; 

a  statement  that  the  device  in  question  conforms  to  the 

essential  requirements  set  out  in  Annex  1  and,  where 

applicable,  indicating  which  essential  requirements  have  not 

been fully met, together with  the grounds. 

2.2 

For  devices  intended  for  the  clinical  investigations  covered  by 

Annex 10: 

data allowing  identification of  the device  in question-, 

an  investigation plan stating  in particular  the purpose, scope 

and number of devices concerned; 

the opinion  of  the  Ethics  Committee  concerned  and  details of 

the aspects covered by  its opinion-, 

-  83  -

the  name of  the medical  specialist  or  other  authorized  person 

and of  the  institution  responsible  for  the  Investigations; 

the  place,  starting  date  and  scheduled  duration  for  the 

invest igat ions; 

a  statement  that  the  device  in  question  conforms  to  the 

essential  requirements  apart  from  the  aspects  covered  by  the 

investigations  and  that,  with  regard  to  these  aspects,  every 

precaution  has been  taken  to protect  the health  and  safety of 

the pat ient. 

3. 

The  manufacturer  shall  also  undertake  to  keep  available  for  the 

competent  national  authorities: 

3.1 

For  custom-made  devices, 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. 

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. 

3.2 

For  devices  intended  for  clinical  investigations,  the documentation 

shalI  contain: 

a general  description of  the product; 

design  drawings,  methods  of  manufacture  envisaged,  in 

particular 

as  regards  sterilization,  and  diagrams  of 

components, sub-assemblies, circuits, etc.-, 

the  descriptions  and  explanations  necessary  to understand  the 

abovementioned  drawings  and  diagrams  and  the operation  of  the 

product ; 

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  this  Directive  if  the 

standards  referred  to  in Article 5 have not  been  applied; 

the results of  the design calculations, and of  the  inspections 

and  technical  tests carried out, etc. 

-  84  -

The  manufacturer  shall  take  all  the  measures  necessary  for  the 

manufacturing  process  to  ensure  that  the  products  manufactured 

conform  to  the  documentation  referred  to  In  the  first  paragraph  of 

this Sect ion. 

The  manufacturer  may  authorize  the  assessment,  or  audit  where 

necessary, of  the effectiveness of  these measures. 

-  85  -

ANNEX 9 

CLASSIFICATION CRITERIA 

I.  CLASSIFICATION  P U US 

1. 

Non-invasive devices 

1.1 

Rule 1 

All  non-invasive  devices are  in Class  I, unless one of  the rules set 

out hereinafter  applies. 

1.2 

Rule 2 

All  non-invasive  devices  intended  for  channelling or  storing  blood, 

body  liquids  or  tissues,  liquids  or  gases  for  the  purpose  of 

eventual  infusion, administration or  introduction  into the body  are 

in Class  lia: 

if they are connected  to an active medical  device  in Class  Ma 

or a higher class; 

if  they  are  used  for  storing  blood  or  other  body  liquids or 

t i ssues. 

in all other  cases they are  in Class I. 

1.3 

Rule 3 

AM  non-invasive  devices  intended  for  modifying  the  biological  or 

chemical  composition  of  blood, other  body  liquids or  other  liquids 

intended  for  infusion  into  the  body  are  in  Class  lib,  unless  the 

treatment  consists  of  filtration,  centrifugation  or  exchanges  of 

gas, heat or solute,  in which case they are  in Class  M a. 

1 .4 

Rule  4 

-  86  -

All  non-invasive  devices  which  come  into  contact  with  injured  skin 

are  in  Class  I  if  they  are  intended  to  be  used  as  a  mechanical 

barrier,  for  compression,  for  the  absorption  of  exudates  or  for 

moisture  permeability. 

They  are  in  Class  Mb  if  they  are  intended  to  be  used  principally 

for  third-degree  burns  or  other  skin  injuries  of  comparable  degree. 

In all  other  cases  they  are  In Class  M a. 

2. 

Invasive  devices 

2.1 

Rule  5 

All  invasive  devices  with  respect  to  body  orifices,  other  than 

surgically 

invasive  devices  and  which  are  not 

intended  for 

connection  to  an  active medical  device: 

are  in Class  I  If  they  are  intended  for  transient  use; 

are  in  Class  Ma  if  they  are  intended  for  short-term  use, 

except  If  they  are  used  in  the  oral  cavity  as  far  as  the 

pharynx,  in  the  anterior  nostrils or  the  external  ear  canal  up 

to  the  ear  drum,  in which  case  they  are  in Class  I; 

are  in Class  Ma  if  they  are  intended  for  long-term  use. 

All  Invasive  devices  with  respect  to  body  orifices,  other  than 

surgically  invasive  devices  intended  for  connection  to  an 

active  medical  device  in  Class  Ma  or  a  higher  class,  are  in 

Class  M a. 

2.2 

Rule  6 

All  surgically  invasive  devices  intended  for  transient  use  are  in 

Class  Ma  unless  they  are: 

-  87  -

intended  to  diagnose,  monitor  or  correct  a  defect  of  the  heart 

or  of  the  central  circulatory  system  through  direct  contact 

with  these  parts  of  the  body,  in  which  case  they  are  in 

Class  111; 

reusable  surgical  instruments,  in  which  case  they  are  in 

Class  I. 

2.3 

Rule  7 

All  surgically  invasive  devices  intended  for  short-term  use  are  in 

Class  Ma  unless  they  are  intended: 

either  to  diagnose,  monitor  or  correct  a  defect  of  the  heart 

or  of  the  central  circulatory  system  through  direct  contact 

with  these  parts  of  the  body,  in  which  case  they  are  in 

Class  I I I ; 

or  for  use  in  direct  contact  with  the  central  nervous  system, 

in which  case  they  are  in Class  III. 

2.4 

Rule  8 

All  implantable  devices  and  long-term  surgically  invasive  devices 

are  in Class  lib unless  they  are  intended: 

to  be  placed  in  the  teeth,  in  which  case  they  are  in 

CI ass  11 a ; 

to  be  used  in  direct  contact  with  the  heart,  the  central 

circulatory  system  or  the  central  nervous  system,  in  which 

case  they  are  in Class  III; 

to  undergo  chemical  change  in  the  body,  to  be  biologically 

active,  to  be  wholly  or  mainly  absorbed,  to  supply  energy  in 

the  form  of  ionizing  radiation  or  to  administer  medicines,  in 

which  case  they  are  in  Class  III,  except  if  the  devices  are 

placed  in  the  teeth. 

-  88  -

3. 

Act ive  devices 

3.1 

Rule  9 

All  active  therapeutical  devices  intended  to  supply  energy  or  to 

administer,  sample  or  exchange  substances  are  in  Class  Ma  unless 

they  are  intended: 

to  administer  potentially  dangerous  levels  or  forms  of  energy 

to  the  human  body,  taking  account  of  the  part  of  the  body 

absorbing  the  energy  and/or  the  density  of  the  energy; 

to  administer  or  exchange  medicines,  body  liquids  or  other 

substances  in  a  potentially  dangerous  way,  taking  account  of 

the  nature  of  the  substances  administered  and  of  the  part  of 

the  body  concerned,  or  in such  a way  that  the  exchange  or  flow 

cannot  be  controlled  by  the  patient. 

In  these  cases,  the  devices  are  in  Class  M b.  All  active 

devices  intended  to  control  and  monitor  the  performance  of 

active  therapeutical  devices  in Class  I lb or  intended  directly 

to  influence  the  performance  of  such  devices  are  in Class  M b. 

3.2 

Rule  10 

All  active  devices  intended  for  diagnosis  are  in Class  M a: 

if  they  are  intended  to  supply  energy  which  will  be  absorbed 

by  the  human  body,  except  for  devices  used  to  illuminate  the 

patient's  body,  in  the  visible  spectrum; 

if  they  are  intended  primarily  to  allow  direct  diagnosis  of 

vital  physiological  processes  in  a  situation  posing  an 

immediate  danger  to  the  patient's  life. 

3.3 

Rule  11 

All  other  active  devices  are  in Class  I. 

-  89  -

Special  rules 

4.1 

Rule  12 

All  devices  incorporating,  as  an  integral  part,  a  substance  which, 

if  used  separately,  can  be  considered  to  be  a medicinal  product,  as 

defined  in  Article  1  of  Directive  65/65/EEC,  and  whose  action  in 

combination  with  the  devices  can  result  in  its  bioavailability,  are 

in Class  III. 

4.2 

Rule  13 

All  devices  used  for  contraception  or  the  prevention  of  the 

transmission  of  a  viral  disease  by  sexual  contact  are  in Class  M b. 

II. 

DEFINITIONS AND IMPLEMENTING RULES 

-  90  -

1. 

DEFINITIONS FOR THE CLASSIFICATION RULES 

1.1 

Pujatlon 

Transient  Normally  intended  for  continuous  use  for  less  than  60 

minutes. 

Short term 

Normally  intended  for  continuous use  for  not more 

than 30 days. 

Long term 

Normally  intended  for continuous use  for more than 

30 days. 

1.2 

Invasive devices 

Invasive device A  device  which,  in  whole  or  in  part,  penetrates 

inside  the body, either  through  a body  orifice or 

through the surface of the body. 

Body orifice 

Any  natural  opening  in  the  body,  including  the 

external  surface of  the eyeball, or  any  permanent 

artificial opening, such as a stoma. 

Surgically Invasive 

device 

A  device  which  penetrates  inside  the  body  through 

the  surface  of  the  body, with  the  aid  or  in the 

context of a surgical operation. 

1-3 

Reusable surgical 

instrument 

Instrument  intended for a surgical operation such as 

cutting, drilling, sawing, scratching, retracting or 

clipping  without  connection  to  any  other  medical 

device  and  which  can be used  in several  different 

operations. 

1.4 

Active medical 

-  91  -

device 

Any  medical  device  connected  to  or  equipped  with  a 

source  of  electrical  energy  or  any  source  of  power 

other  than  that  directly  generated  by  the  human  body 

or  gravity  and which  acts by  converting  this  energy. 

Medical 

devices 

intended 

to  transmit 

energy, 

substances  or  other  elements  between  an  active 

medical 

device  and  the  patient,  without 

any 

significant  change,  are  not  considered  to  be  active 

medical  devices. 

1.5 

Active  therapeutical 

device 

Any  active medical  device,  whether  used  alone  or  in 

combination  with  other  medical  devices,  to  support, 

modify  or  replace  biological  functions  or  structures 

with  a  view  to  treatment  or  alleviation  of  an 

illness,  injury  or  handicap. 

1-6 

Active  device  for 

d i aonos i s 

Any  active  medical  device,  whether  used  alone  or  in 

combination  with  other  medical  devices,  to  supply 

information  for  detecting,  diagnosing,  monitoring  or 

treating  physiological  conditions,  states  of  health, 

illnesses or  congenital  deformities. 

1.7 

Central  circulatory 

system 

The  following  vessels: 

arteriae  pulmonales,  aorta  ascendens,  arteriae 

coronariae, 

arteria 

carotis 

communis, 

arteria 

carotis  externa,  arteria  carotis  interna,  arteriae 

cerebrates,  truncus  brachiocephalicus,  venae  cordis, 

venae  pulmonales,  vena  cava  superior,  vena  cava 

inferior. 

1.8 

Central  nervous 

system 

Brain  and  spinal  cord. 

2. 

IMPLEMENTING RULES 

-  92  -

2.1 

Application  of  the  classification  rules  shall  be  governed  by  the 

intended purpose of  the devices. 

2.2 

if  the  device  is  intended  to  be  used  in  combination  with  another 

device,  the  classification  rules  shall  apply  separately  to  each  of 

the devices. 

2.3 

if the device  is not  intended  to be used  solely or  principally  in a 

specific  part  of  the  body,  it must  be  considered  and  classified  on 

the basis of  the most  critical  use. 

2.4 

If  two  rules  apply  to  the  same  device,  based  on  the  performance 

specified  for  the device by  the manufacturer,  the  rule  resulting  in 

the higher  classification shall  apply. 

-  93  -

ANNEX  10 

CLINICAL  EVALUATION 

1. 

General  provisions 

1.1 

As  a general  rule, confirmation of  conformity  with  the  requirements 

concerning  the  characteristics  and  performances  referred  to  in 

Section  1  of  Annex  1  under  the  normal  conditions  of  use  of  the 

device  and  the  evaluation  of  the  undesirable  side-effects  must  be 

based  on  clinical  data  in  the  case  of  implantable  devices,  devices 

in Class  III and, where  Justified, other  devices.  Taking  account  of 

any  relevant  harmonized  standards,  where  appropriate,  the  adequacy 

of  the clinical  data shall  be based on: 

1.1.1  either  a compilation  of  the relevant  scientific  literature  currently 

available  on  the  intended  purpose  of  the  device  and  the  techniques 

employed  as  well  as,  if appropriate,  a written  report  containing  a 

critical  evaluation  of  this  compilation; 

1.1.2  or  the  results  of  all  the  clinical  investigations  made,  including 

those carried  out  in conformity  with  Section 2. 

1.2 

All  the  data  must  remain  confidential,  in  conformity  with  the 

provisions of Article 20. 

2. 

Clinical  investigation 

2.1 

Objectives 

The objectives of clinical  investigation are: 

to  verify  that,  under  normal  conditions  of  use,  the 

performances  of  the  devices  conform  to  those  referred  to  in 

Section  3 of Annex  1; and 

to  determine  any  undesirable  side-effects,  under  normal 

conditions  of  use,  and  assess  whether  they  are  risks  when 

weighed  against  the  intended  performance  of  the device. 

2.2 

Ethical  considerations 

-  94  -

Clinical  investigations  shall  be  carried  out  in accordance  with  the 

Helsinki  Declaration  adopted  by  the  18th  World  Medical  Assembly  in 

Helsinki,  Finland,  in  1964,  as  last  amended  by  the  41st  World 

Medical  Assembly  in  Hong  Kong  in  1989.  It  is  mandatory  that  all 

measures  relating  to  the  protection  of  human  subjects  are  carried 

out  in  the  spirit  of  the  Helsinki  Declaration.  This  shall  include 

every  step  in the clinical  investigation  from  first  consideration  of 

the  need  and  Justification  of  the  study  to  publication  of  the 

results. 

2.3 

Methods 

2.3.1  Clinical  investigations  shall  be  performed  on  the  basis  of  an 

appropriate  plan  of  investigation  corresponding  to  the  state  of  the 

art  and  defined  in  such  a  way  as  to  confirm  or  refute  the 

manufacturer's  claims  for  the  device-,  these  investigations  shall 

include  an  adequate  number  of  observations  to  guarantee  the 

scientific  validity  of  the conclusions. 

2.3.2  The  procedures  used  to  perform  the  investigations  shall  be 

appropriate  to  the device  under  examination. 

2.3.3  Clinical  investigations  shall  be  performed  in  circumstances  similar 

to  the normal  conditions of  use of  the device. 

2.3.4  All  the  appropriate  features,  including  those  involving  the  safety 

and  performances  of  the  device,  and  its effect  on  patients  shall  be 

examined. 

2.3.5  All  adverse  incidents  shall  be  fully  recorded. 

2.3.6  The  Investigations  shall  be  performed  under  the  responsibility  of  a 

medical  specialist  or  another  authorized  qualified  person  in  an 

appropriate  environment. 

The  medical  specialist  or  other  authorized  person  shall  have  access 

to  the  technical  and  clinical  data  regarding  the device. 

-  95  -

2.3.7  The  written  report,  signed  by  the  medical  specialist  or  other 

authorized  person  responsible,  shall  contain  a  critical  evaluation 

of  all  the data  collected  during  the clinical  investigation. 

-  96  -

ANNEX  11 

MINIMUM  CRITERIA  FOR THE DESIGNATION  OF 

NOTIFIED  INSPECTION 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  authorized 

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  inspection  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 

and,  In particular,  of  this Annex.  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  2  to  6  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.  It  must  also  have  access  to  the  equipment  necessary 

for  the verifications  required. 

4. 

The  inspection  staff  must  have: 

-  97  -

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  the  national  law  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. 

-  98  -

ANNEX 12 

CE MARK OF CONFORMITY 

- 99 

FICHE  FINANCIERE 

VOLET  1  :  IMPLICATIONS  FINANCIERES 

1. 

Int itulé  de  I'act Ion 

Proposition  de  directive  concernant  le  rapprochement  des 
législations  des  Etats  membres  relatives  aux  dispositifs 
méd i eaux . 

2. 

Lignes  budgétaires  concernées 

article  B  5-300 

: actions  relatives  à  l'achèvement  du 

Marché  Intérieur,  dépenses 
opérât ionneII es 

article  B  8-530 

: actions  relatives  à  l'achèvement  du 

Marché  Intérieur,  dépenses  d'appui  et  de 
sout i en . 

3. 

Base  léga I e 

Article  100A  du  Traité  CEE 

4. 

Description  de  l'action 

4.1.  Achèvement  du  Marché  Intérieur  dans  le  secteur  des 

dispositifs  médicaux;  amélioration  de  la  protection  de 
la  santé  et  de  la  sécurité  des  patients  et  des 
ut i Ii sateurs. 

En  suivant  les  principes  de  la  Nouvelle  A p p r o c h e,  la 
directive  harmonise  les  exigences  et  les  procédures 
d'évaluation  de  conformité  auxquelles  doivent  répondre 
les  dispositifs  médicaux  lors  de  leur  mise  sur  le  marché 
et  de  leur  mise  en  service.  La  mise  en  oeuvre  efficace 
implique  auprès  de  la  Commission,  des  Etats  membres  et 
des  organismes  européens  de  normalisation  CEN/CENELEC 
des  activités  dans  les  domaines  suivants  -. 

établissement  des  normes  harmonisées  par  le 
CEN/CENELEC  facilitant  la  preuve  de  la  conformité  aux 
exigences  essentielles  de  la  d i r e c t i v e, 
mise  en  place  par  les  Etats  membres  d'une 
infrastructure  d'autorités  compétentes  assurant  le 
contrôle  du  respect  de  la  directive  ainsi  que  la 
désignation  par  les  Etats  membres  des  organismes  de 
certification  chargés  de  l'évaluation  de  la 
conform i té, 

-  100  -

é t ab I i s s e m e nt 
p e r m e t t a nt  au 
de  p r o t e ct ion 
i n t e r v e n us  av 
é I a b o r a ti on  p 
u t i l es  à  I'a p 
p o r t a nt  sur  s 
c I a ss i f i cat io 
g e st i on  des  p 
d es  d i spos i t i 
s a u v e g a r de  im 
d es  e x p er ts , 
m i se  en  pi ace 
p o r t a nt  sur  I 
c l a s s i f i c a t io 
c a d re  du  syst 

et  g e s t i on  d'un  s y s t è me  d ' a l e r te 

x  E t a ts  m e m b r es  de  p r e n d re  d es  m e s u r es 

s u i te  à  d es  i n c i d e n ts  i n d é s i r a b l es 

ec  des  d i s p os i t i f s, 
ar  la  C o m m i s s i on  des  l i g n es  d i r e c t r i c es 
p l i c a t i on  u n i f o r me  de  la  d i r e c t i ve 
on  champ  d ' a p p l i c a t i on  a i n si  q ue  sur  la 
n  des  d i s p os i t i f s, 
r o c é d u r es  c o n c e r n a nt  la  c l a s s i f i c a t i on 
fs  et  l ' a p p l i c a t i on  de  la  c l a u se  de 
p l i q u a nt  le  r e c o u rs  à  l ' a v is  t e c h n i q ue 

d ' u ne  b a se  e u r o p é e n ne  de  d o n n é es 
a  c e r t i f i c a t i on  des  d i s p o s i t i f s,  la 
n  et  les  i n c i d e n ts  n o t i f i és  d a ns  le 
ème  d ' a l e r t e. 

4 . 2. 

D u r ée  :  e n v i r on  4-5  a n s;  a c t i on  p o n c t u e l l e.  Le  m o n t a nt 
d es  c r é d i ts  a l l o u és  pour  c e t te  a c t i on  s e ra  t o u t e f o is 
d é t e r m i né  c h a q ue  a n n ée  en  f o n c t i on  des  t r a v a ux  r e s t a nt  à 
ef f e c t u e r. 

4 . 3. 

P o p u l a t i on  c o n c e r n ée  :  p o t e n t i e l l e m e n t,  l ' e n s e m b le  de  la 
p o p u l a t i on  c o m m u n a u t a i re  et  des  p a ys  t i e r s. 

C l a s s i f i c a t i on  des  d é p e n s es 

5 . 1. 

D é p e n s es  non  o b l i g a t o i r es 

5 . 2. 

.  B 5 - 3 00  :  c r é d i ts  d i s s o c i és 
.  B 8 - 5 30  :  c r é d i ts  non  d i s s o c i és 

N a t u re  d es  d é p e n s es 

L ' é l a b o r a t i on  des  n o r m es  h a r m o n i s é es  par  le  C E N / C E N E L EC  est 
c o u v e r te  par  une  c o n t r i b u t i on  f i n a n c i è re  de  la  C o m m u n a u té  et 
l'AELE  (part  du  f i n a n c e m e nt  i n c o m b a nt  à  la  CE  .- 8 6 %,  à 
l'AELE  :  1 4 % ). Les  f r a is  r e s t a nt  s e r o nt  c o u v e r ts  par  les 
o r g a n i s m es  de  n o r m a l i s a t i on  et  les  p a r t i es  c o n c e r n é es 
( i n d u s t r i e,  o r g a n i s m es  de  c e r t i f i c a t i on  e t c ). 

Le  f i n a n c e m e nt  sera  o c t r o yé  m o y e n n a nt  des  b o ns  de  c o m m a n de 
p a s s és  en  v e r tu  du  c o n t r a t - c a d re  du  4  août  1 9 89  s i g né  a v ec  le 
C E N / C E N E L E C. 

La  m i se  en  p l a ce  d'une  base  de  d o n n é es  n é c e s s i t e ra  un 
f i n a n c e m e nt  s o us  forme  d ' é t u de  de  f a i s a b i l i té  et  de  p r e s t a t i on 
de  s e r v i c es  au  c o u rs  de  la  p h a se  de  d é m a r r a g e. 

La  f o u r n i t u re  des  a v is  t e c h n i q u es  n é c e s s a i r es  en  vue  des 
q u e s t i o ns  s p é c i f i q u es  d a ns  le  c a d re  de  la  g e s t i on  c o u r a n te 
s e ra  f i n a n c ée  par  des  c o n t r a ts  d ' é t u de  et  de  p r e s t a t i on  de 
s e r v i c e. 

- 101 -

7. 

Incidence  financière  sur  les  crédits  d'intervention  (partie  B 
du  b u d g e t) 

a)  élaboration  des  normes  européennes  (CD) 

1.  M o de  de  calcul 

Le  financement  sera  déterminé  en  fonction  des  travaux  à 
confier  aux  contractants.  Il  sera  calculé  sur  la  base  de 
l'unité  "homme/mois",  qui  s'élève  actuellement  à 
8.000  ECU. 

Le  nombre  de  normes  harmonisées  nécessaires  jusqu'à  fin 
1996  est  de  300.  La  contribution  de  la  Commission  est 
estimée  à  6,25  hommes/mois  par  norme; 
Frais  totaux  :  1.875  hommes/mois,  soit  15  mio  ECU 

2.  L'échéancier  indicatif  des  crédits  pourrait  être  le 

su i vant  : 

Crédits  d'engagement 

(1.000  ECU) 

Crédits  de  pa i ement 
(1.000  ECU) 

1992 
1993 
1994 
1995 
1996 

1  . 5 00 
4 . 0 00 
5 . 0 00 
4 . 5 00 
p . m. 

15.000 

1 .000 
2.000 
4.000 
5.000 
3.000 

15.000 

Le  niveau  des  crédits  à  partir  de  1992  sera  fixé  par  la 
procédure  budgétaire  annuelle  dans  le  cadre  des 
contraintes  fixées  par  les  Perspectives  financières 
post  9 2. 

Pour  1992,  le  montant  global  (mini-budgets  compris)  est 
inclus  dans  le  chiffre  total  des  dépenses  de  -
Notification,  reconnaissance  mutuelle,  harmonisation  des 
législations  techniques,  normalisation  et  rectification 
et  essais  (33.153.000)  de  la  fiche  financière  globale 
des  postes  B5-300  et  B 8 - 5 3 0. 

b)  autres  mesures  financées  par  le  mini-budget 

conformément  à  la  décision  de  la  Commission  du  22.5.1990 
sur  les  mini-budgets 

frais  d'experts  : 450  à  500  ECU  par  expert,  par  Jour 

1992 
1993 
1994 
1995 
1996 

30  x  450  ECU 
30  X  450  ECU 
30  x  450  ECU 
20  x  500  ECU 
20  x  500  ECU 

ECU 

13 
13 
13 
10 
10 

500 
500 
500 
000 
000 

TOTAL  (1992-1996) 

60.500 

- 102 -

frais  pour  la mise  en place  et  le démarrage  de  la base 
de  données, à répartir  en trois  tranches  sur  les années 
1992  à 1994 : 

*  1992 
*  1993 
*  1994 

ECU 

200.000 
200.000 
100.000 

500.000 

TOTAL  (1992-1994) 

8. 

D i s p o s i t i o ns  anti-fraude  prévues  dans  la  p r o p o s i t i on  d'action? 

Le  c o n t r a t - c a d re  visé  sous  le point  6.  prévoit  un 
échelonnement  des  paiements  en  fonction  des  p r o g r ès  des 
t r a v a u x,  ainsi  que  la possibilité  d'un  audit  par  la  Commission 
ou  la  Cour  des  Comptes. 

VOLET  2  : D E P E N S ES  ADM INSTRATIVES  (partie  A  du  b u d g e t) 

L'action  proposée  implique  une  augmentation  du  personnel  statutaire 
affecté  à  la  gestion  de  la directive.  Les  procédures  décisionnelles 
portant  sur  la  classification  des  dispositifs  et  sur  la  clause  de 
s a u v e g a r d e,  le  suivi  de  la normalisation  européenne  présupposent 
l'existence  d'effectifs  pouvant  établir  des  analyses  et  avis 
technico-Juridiques  et  en  organiser  la gestion  a d m i n i s t r a t i v e. 

Les  besoins  en  personnel  sont  à  pourvoir,  soit  par  voie  de 
redéploiement  interne,  soit  par  décision  de  la  C o m m i s s i on 
allocation  ressources  dans  le  cadre  de  la  procédure  b u d g é t a i r e, 
sont  e s t i m é s,  pour  l'unité  III.D.4,  à  partir  de  1992 à : 

I Is 

-  1 A 
-  1 B 

soit  environ  200.000  ECU, à  raison  de  100.000  ECU  en  m o y e n ne  par 
personne  et  par an. 

VOLET  3  : E L E M E N TS  D'ANALYSE  COUT-EFFICACITE 

1. 

O b j e c t i fs  et  cohérence  avec  ia  programmation  f i n a n c i è re 

La  d i r e c t i ve  de  type  Nouvelle  Approche  s'inscrit  dans  le  cadre 
de  l'achèvement  du  Marché  Intérieur.  Le  renvoi  aux  normes 
h a r m o n i s é es  fait  partie  de  l'action  pluriannuelle  de  la 
C o m m i s s i on  qui  consiste  à  soutenir  le  renforcement  et 
l'élargissement  de  la normalisation  e u r o p é e n n e. 

L'action  est  prévue  dans  la programmation  financière  de  la 
DG  III. 

- 103 -

2. 

Justification  de  l'action 

Les  divergences  dans  les  systèmes  nationaux  en  ce  qui  concerne 
les  exigences  pour  les  produits  et  les  procédures  relatives  à 
la  mise  sur  le  marché  entraînent  un  gaspillage  énorme  de 
ressources  humaines  et  financières  à  charge  des  fabricants  et 
des  Etats  m e m b r e s. 

Les  procédures  communautaires  permettront  d'éviter  la 
répétition  multiple  des  procédures  visant  le  même  objet.  De 
plus,  les  exigences  harmonisées  permettront  à  l'industrie  de 
réaliser  des  économies  sur  le  prix  par  unité  de  production,  ce 
qui  pourra  même  avoir  un  effet  bénéfique  sur  les  dépenses  à 
charge  des  systèmes  de  santé  publique. 

Quant  à  l'harmonisation  des  normes,  l'action  vise  à  mettre  en 
commun  les  ressources  et,  de  ce  fait,  à  éviter  la 
multiplication  des  dépenses  pour  l'ensemble  des  Etats  membres. 

Globalement,  les  ressources  requises  à  imposer  au  budget 
communautaire  ne  représentent  qu'une  part  mineure  par  rapport 
à  la  totalité  des  ressources  qui,  de  la  part  des  Etats  membres 
et  des  parties  concernées,  seront  allouées  dans  la  suite  de 
l'action  au  bénéfice  commun. 

3. 

Suivi  et  évaluation  de  l'action 

3.1.  I n d i c a t i on  d es  performances  : 

degré  d'harmonisation  au  plan  de  la  normalisation 
(nombre  de  n o r m e s ), 
nombre  de  certifications  effectuées, 
nombre  de  rapports  notifiés  sur  des  incidents 
i ndés i rabI es , 
nombre  de  procédures  de  clause  de  s a u v e g a r d e. 

3.2.  M o d a l i t és  d es  évaluations  : 

rapports  d'état  des  progrès  périodiques  sur  la 
normalisation  dans  le  cadre  de  la  directive  du 
Conseil  83/189/CEE  ayant  au  minimum  un  caractère 
annue I ; 
échanges  de  vues  dans  un  Comité  sectoriel 
"dispositifs  médicaux". 

3.3.  P r i n c i p a ux  facteurs  d'incertitude  : 

la  désignation  des  organismes  de  certification  par 
les  Etats  membres  se  fait  sur  une  base  facultative  et 
de  manière  décentralisée, 
l'assurance  d'une  application  homogène  d'un  tel 
système  présuppose,  aussi  bien  auprès  des  Etats 
membres  que  sur  le  plan  communautaire,  la 
disponibilité  d'interfaces  assurant  le  fonctionnement 
des  p r o c é d u r e s. 

-  104  -

F i c he  d ' é v a l u a t i on  d ' i m p a ct 

Impact  de  la  p r o p o s i t i on  sur  les  e n t r e p r i s es  e t,  en 
p a r t i c u l i e r,  sur  les  p e t i t es  et  m o y e n n es  e n t r e p r i s es 

T I T RE  DE  LA  P R O P O S I T I ON 

P r o p o s i t i on  de  d i r e c t i ve  c o n c e r n a nt  le  r a p p r o c h e m e nt  d es 
l é g i s l a t i o ns  d es  E t a ts  m e m b r es  r e l a t i v es  aux  d i s p o s i t i fs 
m éd i e a u x. 

N U M E RO  DE  R E F E R E N CE  DU  D O C U M E NT 

2 1 2 1 . 21 

LA  P R O P O S I T I ON 

.1. 

C o m p te  t e nu  du  p r i n c i pe  de  s u b s i d i a r i té ,  p o u r q u oi  une 
l é g i s l a t i on  c o n m u n a u t ai re  e s t - e l le  n é c e s s a i re  d a ns  ce 
d o m a i ne  et  q u e ls  sont  ses  p r i n c i p a ux  o b j e c t i f s? 

L es  r é g l e m e n t a t i o ns  n a t i o n a l es  r e l a t i v es  à  la  m i se  sur  le 
m a r c hé  et  la  m i se  en  s e r v i ce  d es  d i s p o s i t i fs  m é d i c a ux 
p r é s e n t e nt  un  tel  d e g ré  de  d i v e r g e n c es  s u b s t a n t i e l l e s, 
q u ' u ne  libre  c i r c u l a t i on  d a ns  la  C o m m u n a u té  n ' e st  p as 
a s s u r é e.  L ' h a r m o n i s a t i on  d es  e x i g e n c es  et  d es  p r o c é d u r es 
d ' é v a l u a t i on  de  la  c o n f o r m i té  a u x q u e l l es  d o i v e nt  r é p o n d re 
les  d i s p o s i t i fs  m é d i c a ux  p o ur  a s s u r er  la  p r o t e c t i on  d es 
p a t i e n t s,  u t i l i s a t e u rs  et  t i e rs  e s t,  d ès  l o r s,  le  seul  m o y en 
p o ur  a c h e v er  le  m a r c hé  i n t é r i e ur  d a ns  ce  s e c t e u r. 

I M P A CT  S UR  L ES  E N T R E P R I S ES 

2. 

Qui  s e ra  a f f e c té  par  la  p r o p o s i t i o n? 

s e c t e u rs  d ' e n t r e p r i s es  :  tout  f a b r i c a nt  de  d i s p o s i t i fs 
m é d i c a ux  (à  l ' e x c e p t i on  d es  d i s p o s i t i fs 
a c t i f s,  t e ls  que  d es  s t i m u l a t e u rs  c a r d i a q u es  a i n si  q ue 
d es  d i s p o s i t i fs  d e s t i n és  au  d i a g n o s t ic 
e x e m p l es  :  a p p a r e i ls  é l e c t r o m é d i c a u x,  p r o d u i ts  à  u s a ge 
u n i q u e,  m a t é r i a ux  et  p r o t h è s es  d e n t a i r e s,  p r o t h è s es 
o r t h o p é d i q u e s,  i n s t r u m e n t s,  e tc 

i m p l a n t a b l es 

i n - v i t r o ), 

t a i l l es  d es  e n t r e p r i s es  :  t o u te  t a i l l e,  y  c o m p r is  les 
m u l t i n a t i o n a l es  et  le.s  PME 

z o n es  g é o g r a p h i q u es  p a r t i c u l i è r es  d ' i m p l a n t a t i on  :  a u c u ne 

-  105  -

Q u e l l es  m e s u r es  les  e n t r e p r i s es  d e v r o n t -e I I es  p r e n d re  pour 
se  c o n f o r m er  à  la  p r o p o s i t i o n? 

A  p a r t ir  de  l ' a p p l i c a t i on  t o t a le  de  la  d i r e c t i v e,  c ' e s t - à-
d i re  le  1er  J u i l l et  1 9 97  : 

la  c o n c e p t i on  et  la  f a b r i c a t i on  d es  p r o d u i ts  d e v r o nt 
r é p o n d re  aux  e x i g e n c es  de  la  d i r e c t i v e, 
les  f a b r i c a n ts  ou  l e u rs  m a n d a t a i r es  d e v r o nt  s u i v re  les 
p r o c é d u r es  d ' é v a l u a t i on  de  c o n f o r m i té  p r é v u e s. 

Au  c o u rs  d ' u ne  p é r i o de  de  t r o is  a ns  à  p a r t ir  de  la  p r e m i è re 
a p p l i c a t i on  de  la  d i r e c t i ve  ( e n t re  J u in  1 9 94  et  J u in  1 9 9 7 ), 
les  f a b r i c a n ts  p o u r r o n t,  soit  c o n t i n u er  à  a p p l i q u er  les 
l é g i s l a t i o ns  n a t i o n a l es  p r é e x i s t a n t e s,  s o it  se  c o n f o r m er  au 
rég ime  h a r m on i s e. 

Q u a nt  aux  p r o c é d u r es  d ' é v a l u a t i on  de  c o n f o r m i t é,  les 
f a b r i c a n ts  p o u r r o nt  c h o i s i r,  en  c as  d ' i n t e r v e n t i on  d ' u ne 
t i e r ce  p a r t i e,  e n t re  t r o is  ou  q u a t re  p r o c é d u r es 
a l t e r n a t i v e m e nt  a p p l i c a b l e s. 

L es  d i s p o s i t i o ns  t r a n s i t o i r es  a i n si  q ue  le  c h o ix  p o ur  les 
f a b r i c a n ts  e n t re  p l u s i e u rs  p r o c é d u r es  d ' é v a l u a t i on  de  la 
c o n f o r m i té  d e v r o nt  f a c i l i t er  la  t r a n s i t i on  v e rs  le  r é g i me 
h a r m on i s e. 

Q u e ls  e f f e ts  é c o n o m i q u es 
d ' a v o i r? 

a  p r o p o s i t i on  e s t - e l le  s u s c e p t i b le 

sur  I ' e m p lo i  :  a u c un  e f f et  s i g n i f i c a t if  n ' e st  e s c o m p t é. 

s ur  les  i n v e s t i s s e m e n ts  et  la  c r é a t i on  de  n o u v e l l es 
e nt r e p ri s es  :  la  d i r e c t i ve  peut  a v o ir  c o m me  e f f e t, 
n o t a m m e nt  en  ce  qui  c o n c e r ne  les  d i s p o s i t i fs  m é d i c a ux 
p r é s e n t a nt  un  r i s q ue  é l e v é,  q u ' u ne  p a r t ie  d es  e n t r e p r i s es 
d o i v e nt  a d a p t er  l e u rs  p r o c é d és  de  f a b r i c a t i o n,  de  s o r te  à 
p e r m e t t re  u ne  q u a l i té  de  p r o d u c t i on  é l e v ée  et  c o n s t a n t e. 
O r,  c es  i n v e s t i s s e m e n ts  r e n f o r c e r o nt  la  c o m p é t i t i v i té  d es 
e nt r e pr i s e s. 

s ur  la  c o m p é t i t i v i té  d es  e n t r e p r i s es  :  l ' a c t i on  p r o p o s ée 
f a c i l i t e ra  l ' a c c ès  à  un  m a r c hé  de  d i m e n s i on 
c o m m u n a u t a i r e.  C e t te  p e r s p e c t i ve  o u v r i ra  de  n o u v e a ux 
h o r i z o ns  aux  e n t r e p r i s es  de  t a i l le  p l us  m o d e s te  qui  ne 
d i s p o s e nt  p as  de  f i l i a l es  d a ns  c h a q ue  E t at  m e m b re  p o ur 
t r a i t er  d i r e c t e m e nt  a v ec  les  a u t o r i t és  n a t i o n a l es 
c o m p é t e n t e s.  Il  faut  é g a l e m e nt  s o u l i g n er  q ue  les 
e n t r e p r i s es  d e v r o n t,  de  ce  f a i t,  f a i re  f a ce  à  u ne 
i n t e n s i f i c a t i on  de  la  c o n c u r r e n c e. 

La  p r o p o s i t i on  c o n t i e n t - e l le  des  m e s u r es  v i s a nt  à  t e n ir 
c o m p te  de  la  s i t u a t i on  s p é c i f i q ue  des  p e t i t es  et  m o y e n n es 
e n t r e pr  i s e s? 

Non 

- 106 -

CONSULTATION 

Pour  préparer  cette  proposition,  la  Commission  a  o r g a n i s é,  depuis 
1989,  au  moins  cinq  réunions  rassemblant  les  experts 
gouvernementaux  et  les  fédérations  professionnelles.  De  p l u s,  de 
multiples  réunions  bilatérales  avec  les  fédérations  sur  des 
aspects  spécifiques  ont  eu  lieu. 

Ont  été  consultées  : 

les  associations  européennes  de  l'industrie  des  dispositifs 
méd i eaux , 
les  associations  des  utilisateurs,  notamment  des  m é d e c i ns  et 
des  p h a r m a c i e n s. 

La  Commission  a,  dans  une  large  mesure,  tenu  compte  des 
commentaires  reçus  lors  de  la  consultation.  Les  milieux 
intéressés,  y  compris  les  fédérations  industrielles,  ont 
principalement  supporté  l'approche  suivie  dans  la  p r o p o s i t i o n. 

ISSN 0254-1475 

COM(91) 287 final 

DOCUMENTS 

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06 

Catalogue number : CB-CO-91-356-EN-C 

ISBN 92-77-74963-6 

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