CELEX: 51991PC0287
Language: en
Date: 1991-08-23
Title: PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES

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)
 ---pagebreak---  ---pagebreak---                                             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 in vitro           diagnosis are
   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 .
   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 .
 ---pagebreak---                                                 - 3 -
W i t h t h e r e g a r d to the m e a n s of .control u s e d to e n s u r e the
s a f e t y a n d h e a l t h p r o t e c t i o n of p a t i e n t s a n d u s e r s , t w o
d i f f e r e n t a p p r o a c h e s w e r e f o u n d in the C o m m u n i t y . A l a r g e
n u m b e r of t h e M e m b e r S t a t e s a p p l y s y s t e m s b a s e d o n t h e
i n s p e c t i o n of p r o d u c t s b e f o r e t h e y a r e p l a c e d o n t h e m a r k e t
by m e a n s of t y p e - e x a m i n a t i o n s or a p p r o v a l s y s t e m s , w h i l e
o t h e r s a s k c o m p a n i e s to a p p l y g o o d m a n u f a c t u r i n g p r a c t i c e s .
W h e r e t h e d e v i c e s a r e s u b j e c t to the r u l e s o n m e d i c i n a l
p r o d u c t s , b o t h p r o d u c t c e r t i f i c a t i o n and a u t h o r i z a t i o n
p r o c e d u r e s for c o m p a n i e s a p p l y .
T h e i n f o r m a t i o n o b t a i n e d p u r s u a n t to D i r e c t i v e 8 3 / 1 8 9 / E E C
l a y i n g d o w n an i n f o r m a t i o n p r o c e d u r e in the f i e l d of
t e c h n i c a l r e g u l a t i o n s c o n f i r m s the lack of u n i f o r m i t y in the
 l e g i s l a t i v e a p p r o a c h t a k e n w i t h r e g a r d to m e d i c a l d e v i c e s .
B e t w e e n 1 9 8 8 and 1 9 9 0 , s o m e 25 s e t s of d r a f t n a t i o n a l
r e g u l a t i o n s , m o s t of t h e m r e l a t i n g to s p e c i f i c p r o d u c t s ,
w e r e n o t i f i e d to the C o m m i s s i o n .
L a s t l y , it s h o u l d be s a i d that s o m e of the M e m b e r S t a t e s                  are
a w a r e of t h e u n s a t i s f a c t o r y s i t u a t i o n and h a v e i n d i c a t e d
t h e i r d e s i r e to e s t a b l i s h an o v e r a l l legal f r a m e w o r k for              the
medical devices field.
 In v i e w of t h e d i f f e r e n c e s in a p p r o a c h , w h i c h by t h e i r
n a t u r e are incompatible with a single C o m m u n i t y market                              in
m e d i c a l d e v i c e s , it is e s s e n t i a l to set up a C o m m u n i t y
s y s t e m of laws b a s e d on A r t i c l e 100a of the E E C T r e a t y                     to
a b o l i s h a n d p r e v e n t t e c h n i c a l b a r r i e r s to t r a d e .
T h e a i m of t h i s d i r e c t i v e , t h e r e f o r e , is to e n s u r e t h e
s a f e t y a n d h e a l t h p r o t e c t i o n of p a t i e n t s a n d u s e r s by m e a n s
of a u n i f o r m s e c t o r a l a p p r o a c h and to c r e a t e an a p p r o p r i a t e ,
s u i t a b l e f r a m e w o r k for the t e c h n o l o g i c a l d e v e l o p m e n t of the
products concerned.
T h e m e d i c a l d e v i c e s s e c t o r is a large m a r k e t : w o r l d
c o n s u m p t i o n of t h e s e p r o d u c t s in 1 9 9 0 h a s b e e n put at
ECU 5 4 . 1 b i l l i o n , i n c l u d i n g ECU 23.1 b i l l i o n in t h e U S A a(1
ECU - 1.2 U S $ ) and ECU 1 5 . 0 b i l l i o n in the C o m m u n i t y
 (source: Health Industry M a n u f a c t u r e r s A s s o c i a t i o n ( H I M A ) ) .
T h e C o m m u n i t y s h a r e of w o r l d p r o d u c t i o n h a s b e e n c a l c u l a t e d
to be E C U 16.1 b i l l i o n ( U S A : 2 5 . 7 - J a p a n : 8 . 0 ) . B e t w e e n
1 9 8 6 a n d 1 9 8 9 , the a n n u a l a v e r a g e g r o w t h in c o n s u m p t i o n w a s
9 . 5 % ( U S A : 9 . 9 % - J a p a n : 8 . 6 % ) . T h e n u m b e r of J o b s in t h i s
b r a n c h of i n d u s t r y w i t h i n the C o m m u n i t y t o t a l l e d o v e r
2 0 0 0 0 0 in 1 9 9 0 .
 ---pagebreak---                                                        - A -
      In v i e w of t h e r a p i d s p e e d of i n n o v a t i o n in t h i s s e c t o r ,
      C o m m u n i t y l e g i s l a t i o n w i l l p r o v i d e an a p p r o p r i a t e f r a m e w o r k
      w h i c h w i l l h e l p to m a i n t a i n a n d to p r o m o t e t h i s f a v o u r a b l e
      deve I opment.
      T h e p r o p o s a l for a d i r e c t i v e h a s b e e n d e s i g n e d a n d
      s t r u c t u r e d , a s r e g a r d s t e c h n i c a l r e q u i r e m e n t s , in t h e light
      of t h e C o u n c i l R e s o l u t i o n of 7 M a y 1 9 8 5 o n a n e w a p p r o a c h to
      t e c h n i c a l h a r m o n i z a t i o n and s t a n d a r d i z a t i o n      The
      l e g i s l a t o r s a l r e a d y a p p l i e d t h e p r i n c i p l e s s e t o u t in t h e
      abovementioned                R e s o l u t i o n w i t h t h e a d o p t i o n of C o u n c i l
      D i r e c t i v e 9 0 / 3 8 5 / E E C of 2 0 J u n e 1 9 9 0 r e l a t i n g to a c t i v e
      implantable medical devices                              This proposal therefore
       i n c l u d e s what has been a c h i e v e d with that D i r e c t i v e and
      t r a n s p o s e s it to t h e m e d i c a l d e v i c e s w h i c h it c o v e r s .
      T h e i m p l e m e n t a t i o n of t h e c o n c e p t of r e f e r e n c e to s t a n d a r d s
      w i l l be f a c i l i t a t e d by t h e f a c t t h a t s o m e of t h e h a r m o n i z e d
      E u r o p e a n s t a n d a r d s , in p a r t i c u l a r t h o s e of a h o r i z o n t a l
      n a t u r e , w i l l a l r e a d y be a v a i l a b l e f r o m t h e a p p l i c a t i o n of
      t h e D i r e c t i v e r e l a t i n g to a c t i v e i m p l a n t a b l e m e d i c a l
      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 n t w o r k o n t h e e s t a b l i s h m e n t of
      a s e c t o r a l s y s t e m of h a r m o n i z e d s t a n d a r d s h a s a l r e a d y b e e n
      s t a r t e d by C E N / C E N E L E C .
      T h e p a r t of t h e d i r e c t i v e r e l a t i n g to p r o c e d u r e s for t h e
      a s s e s s m e n t of c o n f o r m i t y is b a s e d on t h e m o d u l a r a p p r o a c h
      set o u t in C o u n c i l D e c i s i o n 9 0 / 6 8 3 / E E C of 13 D e c e m b e r 1 9 9 0
      T h e a p p r o a c h f o l l o w e d w i t h r e g a r d to t h e a s s e s s m e n t of
      c o n f o r m i t y e n a b l e s a d i s t i n e t i o n to be m a d e w i t h r e g a r d to
      v e r i f i c a t i o n s c a r r i e d o u t by a t h i r d p a r t y a c c o r d i n g to t h e
      n a t u r e of t h e p o t e n t i a l r i s k i n h e r e n t in m e d i c a l d e v i c e s .
      For t h i s r e a s o n a n d in v i e w of the d i v e r s i t y of p r o d u c t s
      c o n c e r n e d , t h e d e v i c e s c o v e r e d by t h e d i r e c t i v e h a v e b e e n
      d i v i d e d i n t o f o u r c l a s s e s for the p u r p o s e of a s s e s s m e n t
      procedures .
      T h e i n t e r v e n t i o n of t h e c e r t i f i c a t i o n b o d i e s ( n o t i f i e d
      b o d i e s ) h a s b e e n g r a d e d . For d e v i c e s in C l a s s I, c o n f o r m i t y
       is e s t a b l i s h e d a s a g e n e r a l r u l e u n d e r t h e r e s p o n s i b i l i t y
      of t h e m a n u f a c t u r e r a l o n e . C l a s s M a d e v i c e s r e q u i r e , in
      v i e w of t h e r i s k s m o r e c l o s e l y a s s o c i a t e d w i t h m a n u f a c t u r e ,
      t h e i n t e r v e n t i o n of a n o t i f i e d b o d y w i t h r e g a r d to t h e
      manufacture stage.                     For d e v i c e s in C l a s s e s M b a n d I I I , o n
      t h e o t h e r h a n d , v e r i f i c a t i o n by a n o t i f i e d b o d y is
      n e c e s s a r y w i t h r e g a r d to d e s i g n a n d t h e m a n u f a c t u r i n g
      s t a g e . F u r t h e r m o r e , C l a s s III d e v i c e s w h i c h a r e c r i t i c a l
      d e v i c e s s h o u l d , as a g e n e r a l r u l e , u n d e r g o a c l i n i c a l
      e v a l u a t i o n u n d e r t h e r e s p o n s i b i l i t y of t h e m a n u f a c t u r e r .
      T h e c o n f o r m i t y of t h e i r d e s i g n m u s t be e x p l i c i t l y c e r t i f i e d
      by a n o t i f i e d b o d y b e f o r e t h e y a r e p l a c e d o n t h e m a r k e t .
CD  OJ No C 1 3 6 , 4 . 6 . 1 9 8 5 , p . 1 .
ic) OJ He L 1 8 9 , 2 C . 7 . i 9 9 0, p . 1 7 .
(3) OJ No L 3 8 0          31.12. 1990, p              13
 ---pagebreak--- I I. CONTENTS           OF   THE     PROPOSAL
1•   Article          1 -     Scope
     S e v e r a l d e f i n i t i o n s , in p a r t i c u l a r t h o s e of a " m e d i c a l
     d e v i c e " , a " c u s t o m - m a d e d e v i c e " a n d a " d e v i c e i n t e n d e d for
     c l i n i c a l i n v e s t i g a t i o n " have been taken from the D i r e c t i v e
     r e l a t i n g to a c t i v e i m p l a n t a b l e m e d i c a l d e v i c e s . S i n c e t h e
     s c o p e of t h i s p r o p o s a l is b r o a d e r t h a n that of t h e
     a b o v e m e n t i o n e d D i r e c t i v e , a few s l i g h t a m e n d m e n t s h a v e
     therefore been made.
     T h e t e r m " m e d i c a l d e v i c e " m e a n s p r o d u c t s t h e f u n c t i o n of
     w h i c h is s o l e l y or p r i n c i p a l l y m e d i c a l . A s e r i e s of p r o d u c t s
     w h o s e f u n c t i o n is not e s s e n t i a l l y m e d i c a l a r e t h e r e f o r e
     e x c l u d e d f r o m t h e s c o p e , e v e n if t h e s e p r o d u c t s m a y be u s e d
     to p r e v e n t d i s e a s e or a l l e v i a t e a h a n d i c a p , e . g . c o s m e t i c
     products, multiple-use data-processing equipment.
     T h e m e d i c a l f u n c t i o n of a m e d i c a l d e v i c e m a y be f u l f i l l e d
     e i t h e r by m e a n s of a p r o d u c t u s e d on its o w n or a s t h e
     r e s u l t of t h e c o m b i n a t i o n of s e v e r a l p r o d u c t s , e . g .
     d i s p o s a b l e t u b i n g s c o m b i n e d w i t h an i n f u s i o n p u m p .
     T h e c r i t e r i o n for t h e d i s t i n c t i o n b e t w e e n a m e d i c a l d e v i c e
     a n d a m e d i c i n a l p r o d u c t is the p r i n c i p a l a c t i o n p r o d u c e d . A
     p r o d u c t w h i c h a c h i e v e s its p r i n c i p a l a c t i o n 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 a l or m e t a b o l i c m e a n s is not
     c o n s i d e r e d to be a m e d i c a l d e v i c e . H o w e v e r , a m e d i c a l       device
     m a y i n c l u d e a m e d i c i n a l s u b s t a n c e as an i n t e g r a l p a r t in
     o r d e r to i n c r e a s e 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 e d
     catheter .
     W h e r e t h e a c t i o n p r o d u c e d by the p r e s e n c e of t h e m e d i c i n a l
     s u b s t a n c e is s e c o n d a r y to the p r i n c i p a l a c t i o n of t h e
     d e v i c e , t h e c o n f o r m i t y a s s e s s m e n t p r o c e d u r e for a u t h o r i z i n g
     t h e p l a c i n g of t h e p r o d u c t c o n c e r n e d o n t h e m a r k e t is
     c o v e r e d by t h i s p r o p o s a l for a d i r e c t i v e . A s far a s s a f e t y
     a s p e c t s c o n c e r n i n g the p r e s e n c e of the s u b s t a n c e a r e
     c o n c e r n e d , the v e r i f i c a t i o n s r e q u i r e d are c a r r i e d o u t , w h e r e
     a p p r o p r i a t e , by a n a l o g y to the m e t h o d s c o n t a i n e d in
     D i rect i ve 7 5 / 3 1 8 / E E C .
 ---pagebreak---                                                - 6 -
O n t h e o t h e r h a n d , w h e r e a d e v i c e is i n t e n d e d to a d m i n i s t e r
a m e d i c i n a l p r o d u c t and t h e r e f o r e c o n s t i t u t e s a c o n t a i n e r
for t h a t p r o d u c t , e . g . a p r e - f i l l e d s y r i n g e , t h e a s p e c t s
r e l a t i n g to t h e s a f e t y of t h e d e v i c e a r e c o v e r e d by t h i s
p r o p o s a l , w h i l e t h e p l a c i n g of the m e d i c i n a l p r o d u c t o n t h e
m a r k e t is s u b j e c t to t h e C o m m u n i t y l e g i s l a t i o n r e l a t i n g to
m e d i c i n a l p r o d u c t s ( s e e A r t i c l e 1, p a r a . 3 ) .
T h e k e y legal d e f i n i t i o n s i n c l u d e d e f i n i t i o n s of " p l a c i n g o n
the m a r k e t " and the " m a n u f a c t u r e r " . The " p l a c i n g on the
m a r k e t " m e a n s t h e p h y s i c a l t r a n s f e r of a m e d i c a l d e v i c e f r o m
t h e m a n u f a c t u r e r or a p e r s o n a u t h o r i z e d by h i m to t h e
d i s t r i b u t o r or u s e r . P l a c i n g on the m a r k e t m u s t not be
c o n f u s e d w i t h t h e r i g h t , u n d e r the d i r e c t i v e , to m a r k e t
m e d i c a l d e v i c e s in the E u r o p e a n C o m m u n i t y . T h e d e f i n i t i o n of
t h e m a n u f a c t u r e r is u s e f u l in o r d e r to be a b l e to d e t e r m i n e
t h e n a t u r a l or legal p e r s o n s s u b j e c t in p a r t i c u l a r to t h e
conformity assessment procedures (Article 1 0 ) .
T h e s c o p e of t h i s p r o p o s a l i n c l u d e s m e d i c a l d e v i c e s w h i c h
e m i t i o n i z i n g r a d i a t i o n . It t h e r e f o r e s p e c i f i e s t h e
r e q u i r e m e n t s r e l a t i n g to the d e s i g n and m a n u f a c t u r e of t h e
e q u i p m e n t c o n c e r n e d and the c o n f o r m i t y a s s e s s m e n t
p r o c e d u r e s . The d i r e c t i v e d o e s n o t , h o w e v e r , a f f e c t the
a u t h o r i z a t i o n r e q u i r e d u n d e r D i r e c t i v e 8 0 / 8 3 6 / E u r a t o m for
t h e p u t t i n g into s e r v i c e a n d u s e of s u c h e q u i p m e n t .
Articles           2 and     3
T h e s e are c o n v e n t i o n a l A r t i c l e s based on the new a p p r o a c h
r e l a t i n g to p l a c i n g o n the m a r k e t , p u t t i n g into s e r v i c e and
essential requirements.
Article 4 - Free                 movement,         devices       intended       for      special
purposes
 In a d d i t i o n to t h e c o n v e n t i o n a l c l a u s e c o n c e r n i n g f r e e
m o v e m e n t , t h i s A r t i c l e r e f e r s to d e v i c e s i n t e n d e d for
 s p e c i a l p u r p o s e s , i.e. d e v i c e s i n t e n d e d for c l i n i c a l
 i n v e s t i g a t i o n and c u s t o m - m a d e d e v i c e s .
 D e v i c e s i n t e n d e d for c l i n i c a l i n v e s t i g a t i o n a r e m a d e
 a v a i l a b l e to m e d i c a l p r a c t i t i o n e r s w h e n t o t a l c o m p l i a n c e
w i t h t h e e s s e n t i a l r e q u i r e m e n t s s t i l l h a s to be e s t a b l i s h e d
 s o t h a t t h e d e v i c e c a n u n d e r g o an a s s e s s m e n t of c o n f o r m i t y
 p r o c e d u r e . T h e c a r r y i n g o u t of c l i n i c a l      investigations
 s p e c i f i c a l l y m a k e s it p o s s i b l e to c o n f i r m c o n f o r m i t y w i t h
 the r e l e v a n t e s s e n t i a l r e q u i r e m e n t s .     Such d e v i c e s therefore
 do not b e a r t h e CE m a r k .
 ---pagebreak---                                                  - 7 -
C u s t o m - m a d e d e v i c e s a r e m a d e in a c c o r d a n c e w i t h t h e
p r e s c r i p t i o n of a m e d i c a l s p e c i a l i s t or a n y o t h e r a u t h o r i z e d
p e r s o n g i v i n g t h e s p e c i f i c d e s i g n c h a r a c t e r i s t i c s of t h e
d e v i c e c o n c e r n e d . C o m p l i a n c e w i t h the r e q u i r e m e n t s of t h e
d i r e c t i v e is t h e r e f o r e e s t a b l i s h e d u n d e r t h e J o i n t
r e s p o n s i b i l i t y of t h e m a n u f a c t u r e r a n d t h e p e r s o n i s s u i n g
t h e p r e s c r i p t i o n a n d t h i s is w h y s u c h d e v i c e s d o not h a v e to
b e a r t h e CE m a r k .
Article          5 - Reference           to    standards
T h e r e f e r e n c e to h a r m o n i z e d     standards        clause       is b a s e d on   the
C o u n c i l R e s o l u t i o n of 7 M a y        1985.
By m e a n s of t h e r e f e r e n c e to c e r t a i n m o n o g r a p h s of t h e
E u r o p e a n P h a r m a c o p o e i a in p a r a g r a p h 2 , t h e C o m m u n i t y is
d i s c h a r g i n g the o b l i g a t i o n s incumbent on the M e m b e r S t a t e s
p u r s u a n t to t h e C o n v e n t i o n of 22 J u l y 1 9 6 4 o n t h e
p r e p a r a t i o n of a E u r o p e a n P h a r m a c o p o e i a .
 In t h e f i e l d of t h e m e d i c a l d e v i c e s c o v e r e d by t h i s
p r o p o s a l , the E u r o p e a n P h a r m a c o p o e i a has p r e p a r e d s e v e r a l
m o n o g r a p h s r e l a t i n g in p a r t i c u l a r to s u t u r e s a n d t h e
i n t e r a c t i o n b e t w e e n c e r t a i n m a t e r i a l s u s e d for d e v i c e s a n d
m e d i c i n a l p r o d u c t s . S u b j e c t to A r t i c l e 5, p a r a g r a p h 2 , t h e s e
m o n o g r a p h s will have the same s t a t u s , u n d e r t h i s p r o p o s a l ,
as h a r m o n i z e d s t a n d a r d s . T h e a p p l i c a t i o n of t h e m o n o g r a p h s
will t h e r e f o r e remain v o l u n t a r y .
T h e C o m m i s s i o n h a s p r o p o s e d to the C E N a n d t h e E u r o p e a n
P h a r m a c o p o e i a t h e c o n c l u s i o n of a m e m o r a n d u m of
u n d e r s t a n d i n g to d e t e r m i n e the r e s p e c t i v e f i e l d s of a c t i v i t y
and to e s t a b l i s h c o l l a b o r a t i o n in a r e a s of c o m m o n           interest.
Articles          6 and      7. - C o m m i t t e e s
R e g a r d l e s s of t h e c o n v e n t i o n a l r o l e of t h e C o m m i t t e e set up
u n d e r D i r e c t i v e 8 3 / 1 8 9 / E E C ( c f . A r t i c l e 5 ( 3 ) ) , t h e f i e l d of
a c t i v i t y of t h e A d v i s o r y C o m m i t t e e set up u n d e r D i r e c t i v e
9 0 / 3 8 5 / E E C h a s b e e n e x t e n d e d to the s e c t o r c o v e r e d by t h e
p r o p o s a l . A n y m a t t e r r e l a t i n g to the i m p l e m e n t a t i o n a n d
p r a c t i c a l a p p l i c a t i o n of t h e D i r e c t i v e m a y be b r o u g h t b e f o r e
this Comm i 11ee.
 ---pagebreak---                                                  - 8 -
W i t h r e g a r d to t h e c l a s s i f i c a t i o n of m e d i c a l d e v i c e s into
f o u r c l a s s e s of p r o d u c t s ( s e e A r t i c l e s 8 a n d 1 2 ) , r e g u l a t o r y
m e a s u r e s h a v e to be laid d o w n at C o m m u n i t y level for t h e
p r o d u c t s c o n c e r n e d . In v i e w of the n a t u r e of t h e s e m e a s u r e s
a n d t h e c o n s e q u e n c e s as r e g a r d s the level of i n t e r v e n t i o n of
t h i r d p a r t i e s , t h e m e a s u r e s s h o u l d be a d o p t e d in a c c o r d a n c e
w i t h t h e " R e g u l a t o r y C o m m i t t e e " p r o c e d u r e ( v a r i a n t Ilia of
C o u n c i l D e c i s i o n 8 7 / 3 7 3 / E E C of 13 J u l y 1 9 8 7 l a y i n g d o w n the
p r o c e d u r e s for t h e e x e r c i s e of i m p l e m e n t i n g p o w e r s c o n f e r r e d
on the C o m m i s s i o n ) .
Article           8 -    Safeguard          clause
T h i s A r t i c l e is b a s e d          on the C o u n c i l R e s o ut i on        of
7 May 1985 c o n c e r n i n g              the n e w a p p r o a c h .
Articles           9   and 13        -    Classification
M e d i c a l d e v . c e s a r e d i v i d e d into f o u r p r o d u c t c l a s s e s in
o r d e r to be a b l e to d e c i d e on the a p p r o p r i a t e level of
i n t e r v e n t i o n by t h e n o t i f i e d b o d i e s . T h e c l a s s i f i c a t i o n
r u l e s set o u t in A n n e x 9 e n a b l e m a n u f a c t u r e r s to c l a s s i f y
t h e i r p r o d u c t s a c c o r d i n g to the r e l e v a n t c l a s s . W h e r e t h e r e
 is d o u b t , m a n u f a c t u r e r s m a y c o n t a c t the c o m p e t e n t
a u t h o r i t i e s w h i c h , for t h e i r p a r t , m a y , if n e c e s s a r y ,
 i n i t i a t e the C o m m u n i t y d e c i s i o n - m a k i n g p r o c e s s .
D e c i s i o n s m a y h a v e to be t a k e n w i t h r e g a r d to t h e
c l a s s i f i c a t i o n of m e d i c a l d e v i c e s in p a r t i c u l a r w h e r e :
       the     c l a s s i f i c a t i o n r u l e s and    the C o m m i s s i o n  g u i d e l i n e s do
       not     enable a straightforward                     classification           to be made-,
       t h e e x p e r i e n c e o b t a i n e d w i t h s p e c i f i c f a m i l i e s of
       p r o d u c t s j u s t i f i e s a r e c l a s s i f i c a t i o n by w a y of
       d e r o g a t i o n f r o m the c l a s s i f i c a t i o n r u l e s ;
       the c l a s s i f i c a t i o n rules         n e e d to be a d j u s t e d in t h e light
      of t e c h n i c a l d e v e l o p m e n t     and/or e x p e r i e n c e with given
       dev i ces .
 ---pagebreak---                                                  - 9 -
A r t i c l e 10 - I n f o r m a t i o n o n i n c i d e n t s o c c u r r i n g     following
p l a c i n g of d e v i c e s o n t h e m a r k e t
T h i s A r t i c l e s e t s up a C o m m u n i t y w a r n i n g s y s t e m r e g a r d i n g
i n c i d e n t s o c c u r r i n g w i t h d e v i c e s a l r e a d y p l a c e d on the
m a r k e t . T h i s s y s t e m w i l l e n a b l e t h e M e m b e r S t a t e s to t a k e
a p p r o p r i a t e m e a s u r e s e a r l y on w h e r e an i n c i d e n t s u g g e s t s
t h a t , b e c a u s e of a d e s i g n or m a n u f a c t u r i n g f a u l t , a d e v i c e
m a y s e r i o u s l y d a m a g e t h e h e a l t h of p a t i e n t s or u s e r s .
T h e o b l i g a t i o n s o n m a n u f a c t u r e r s to n o t i f y c e r t a i n i n c i d e n t s
a r e set o u t in A n n e x 2 , p o i n t 3 . 1 , A n n e x 4 , p o i n t 3, A n n e x
5, p o i n t 3 . 1 , a n d A n n e x 6, p o i n t 3 . 1 . E a c h M e m b e r S t a t e m u s t
set up a c e n t r a l u n i t to r e c o r d and e v a l u a t e t h e r e p o r t s
o b t a i n e d . W h e r e m e a s u r e s h a v e to be t a k e n by t h e n a t i o n a l
a u t h o r i t i e s , the M e m b e r S t a t e c o n c e r n e d must inform the
o t h e r M e m b e r S t a t e s a n d the C o m m i s s i o n .
Article 11r            Annexes         2 to 7 - C o n f o r m i t y      assessment
procedures
Suitable conformity assessment procedures have been selected
f r o m a m o n g t h o s e a d o p t e d in C o u n c i l D e c i s i o n 9 0 / 6 8 3 / E E C of
13 D e c e m b e r 1 9 9 0 a n d s u p p l e m e n t e d a c c o r d i n g to s e c t o r a l
requirements.               T h e m i n o r a d d i t i o n s m a d e r e f e r in p a r t i c u l a r
to t h e d o c u m e n t a t i o n r e q u i r e d , the s a f e t y of c o m b i n e d
d e v i c e s , s t e r i l i z a t i o n p r o c e d u r e s and c l i n i c a l d a t a . T h e
f o l l o w i n g p r o c e d u r e s a p p l y to the four c l a s s e s of d e v i c e s :
       C I ass I             t h e m a n u f a c t u r e r a l o n e is r e s p o n s i b l e   for the
                             a s s e s s m e n t of c o n f o r m i t y ( m o d u l e A of       Council
                             Decision 90/683/EEC)
       C I ass      I I a    t h e m a n u f a c t u r e r h i m s e l f is r e s p o n s i b l e for
                             a s s e s s i n g the p r o d u c t d e s i g n . T h e
                             i n t e r v e n t i o n of a n o t i f i e d b o d y is r e q u i r e d
                             at t h e p r o d u c t i o n s t a g e ( m o d u l e A c o m b i n e d
                             w i t h e i t h e r m o d u l e s D , E or F ) . F u r t h e r m o r e ,
                             t h e m a n u f a c t u r e r m a y opt for full q u a l i t y
                             a s s u r a n c e ( m o d u l e H ) , a l t h o u g h the p r o c e d u r e
                             s p e c i f i e d in that m o d u l e is m o r e r e s t r i c t i v e
                             than those mentioned a b o v e .
 ---pagebreak---                                                        - 10 -
         C I ass       II b       t h e d e s i g n and m a n u f a c t u r e of t h e p r o d u c t
                                  m u s t be r e f e r r e d to a n o t i f i e d b o d y . T h e
                                  m a n u f a c t u r e r m a y f o l l o w e i t h e r t h e full
                                  q u a l i t y a s s u r a n c e p r o c e d u r e ( m o d u l e H ) or
                                  s u b m i t a p r o t o t y p e for t y p e - e x a m i n a t i o n
                                  ( m o d u l e B ) . In the c a s e of t h e l a t t e r , t h e
                                  m a n u f a c t u r e r m u s t a l s o a p p l y o n e of t h e
                                  p r o c e d u r e s r e f e r r e d to in m o d u l e s D , E or F
   -     Class        II I        t h e p r o c e d u r e s a r e b r o a d l y t h e s a m e as t h o s e
                                  set out for C l a s s M b . H o w e v e r , if full
                                  q u a l i t y a s s u r a n c e is a p p l i e d ( m o d u l e H ) t h e
                                  f i l e r e l a t i n g to the p r o d u c t d e s i g n m u s t 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 s s of t h e
                                  p r o c e d u r e f o l l o w e d the d e s i g n f i l e m u s t as a
                                  g e n e r a l r u l e i n c l u d e an a s s e s s m e n t of
                                  c o n f o r m i t y b a s e d on c l i n i c a l d a t a ( s e e
                                  A n n e x 1 0 , po i nt 1 . 1 ) .
   T h e m a n u f a c t u r e r s ' c h o i c e of s e v e r a l p r o c e d u r e s w i l l m a k e it
   p o s s i b l e to s e l e c t the m o s t a p p r o p r i a t e p r o c e d u r e t a k i n g
   a c c o u n t in p a r t i c u l a r of the p r e - e x i s t i n g r e g u l a t o r y s y s t e m
   a n d t h e n a t u r e and s i z e of the c o m p a n y .
10 Article          12    - Assembly             and     sterilization
   T h i s A r t i c l e r e f e r s to a s s e m b l y and s t e r i l i z a t i o n a c t i v i t i e s
   c a r r i e d o u t c o m m e r c i a l l y . It a p p l i e s to d e v i c e s a l r e a d y
   b e a r i n g t h e CE m a r k . T h e p e r s o n w h o c a r r i e s o u t t h e
   a c t i v i t i e s c o n c e r n e d is not c o n s i d e r e d to be the
   m a n u f a c t u r e r as l e g a l l y d e f i n e d w h e r e t h e a c t i v i t i e s a r e
   c a r r i e d o u t in a c c o r d a n c e w i t h the m a n u f a c t u r e r ' s
    i nst r u c t i o n s .
    If, h o w e v e r , a s s e m b l y and s t e r i l i z a t i o n g o b e y o n d the l i m i t s
    laid d o w n by t h e m a n u f a c t u r e r of the d e v i c e s , t h e y a r e
   s p e c i f i c m a n u f a c t u r i n g a c t i v i t i e s w h i c h a r e t h e n s u b j e c t to
   t h e p r o c e d u r e s set out in A r t i c l e 1 0 .
   The      p r o c e d u r e s r e f e r r e d to in A r t i c l e          11    apply       regardless  of
   the      c l a s s i f i c a t i o n of the d e v i c e .
 ---pagebreak---                                                   - 11     -
11• A r t i c l e 14      - Registration            of   persons        responsible      for      placing
    d e v i c e s on      the m a r k e t
    T h i s A r t i c l e a p p l i e s to d e v i c e s w h i c h a r e not s u b j e c t to
    i n s p e c t i o n by a n o t i f i e d b o d y b e f o r e b e i n g p l a c e d on t h e
    m a r k e t . T h e s e a r e the C l a s s I d e v i c e s and c u s t o m - m a d e
    d e v i c e s . For t h e s e d e v i c e s , the m a n u f a c t u r e r or p e r s o n ( s )
    r e s p o n s i b l e for p l a c i n g t h e m o n the m a r k e t m u s t I n f o r m the
    c o m p e t e n t a u t h o r i t i e s of t h e a d d r e s s of t h e i r r e g i s t e r e d
    p l a c e of b u s i n e s s and the c a t e g o r y of d e v i c e s c o n c e r n e d .
    T h i s n o t i f i c a t i o n e n a b l e s the M e m b e r S t a t e s to h a v e b e t t e r
    c o n t r o l of t h e d e v i c e s in q u e s t i o n w h i c h a r e m a r k e t e d in
    t h e i r t e r r i t o r y a n d , if n e c e s s a r y , to t a k e a p p r o p r i a t e
    measures .
12  Article         15    - Clinical          investigation
    C l i n i c a l i n v e s t i g a t i o n s m a y be n e c e s s a r y in o r d e r to c o n f i r m
    that a d e v i c e f u l l y c o m p l i e s w i t h the e s s e n t i a l
    r e q u i r e m e n t s . T h e c o m p e t e n t a u t h o r i t i e s of e a c h M e m b e r S t a t e
     in w h i c h t h e i n v e s t i g a t i o n s a r e c a r r i e d o u t m u s t be a b l e 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 c t the h e a l t h of p a t i e n t s
    and p u b l i c o r d e r . A r t i c l e 1 4 , p a r a g r a p h 2 , lays d o w n a t a c i t
    a p p r o v a l p r o c e d u r e for i m p l a n t a b l e and o t h e r d e v i c e s in
    C l a s s III.
    T h e r i g h t of i n t e r v e n t i o n of the c o m p e t e n t a u t h o r i t i e s is
    c e n t r e d on c o n s i d e r a t i o n s of p u b l i c h e a l t h a n d p u b l i c o r d e r .
    For t h i s r e a s o n , i n t e r v e n t i o n by the a u t h o r i t i e s d o e s not
     i n c l u d e a p r e l i m i n a r y e v a l u a t i o n of o t h e r a s p e c t s w h i c h a r e
    t h e s u b j e c t of the c o n f o r m i t y a s s e s s m e n t p r o c e d u r e s . T h e
     r o l e of an e t h i c s c o m m i t t e e in t h i s c o n t e x t is to e v a l u a t e
     t h e a c c e p t a b i l i t y of the p l a n of i n v e s t i g a t i o n s f r o m t h e
    v i e w p o i n t of p a t i e n t h e a l t h and e t h i c a l c o n s i d e r a t i o n s .
    T h e c o m p e t e n t a u t h o r i t i e s a r e not b o u n d by         the o p i n i o n
    e x p r e s s e d by an e t h i c s c o m m i t t e e . H o w e v e r ,     s u c h an o p i n i o n
    m a y m a k e it e a s i e r for t h e m to e x a m i n e the                file.
13. Articles           1 6 to 1 9 - N o t i f i e d     bodies,, EC         mark
    These        are     Articles       typical      of    t h e new      approach     directives
 ---pagebreak---                                                     - 12 -
14. Article         20    -    Confidentiality
    T h e o b s e r v a n c e of c o n f i d e n t i a l i t y is e s s e n t i a l for t h e
    p r o t e c t i o n of s p e c i f i c d a t a and b e c a u s e of t h e e c o n o m i c
    impact of t h e p r o c e d u r e s for the p a r t i e s c o n c e r n e d .
15. Article          21    -   Guidelines
    T h e d o c u m e n t s r e f e r r e d to in the g u i d e l i n e s a r e b a s e d o n the
    p r a c t i c e f o l l o w e d w i t h r e g a r d to m e d i c i n a l p r o d u c t s as set
    o u t in D i r e c t i v e 8 9 / 3 4 1 / E E C .       The g u i d e l i n e s may p r o v i d e
    u s e f u l i n f o r m a t i o n for the a p p l i c a t i o n of the d i r e c t i v e ,
    a l t h o u g h t h e y do not t h e m s e l v e s h a v e a n y legal f o r c e . T h e y
    w i l l c o v e r a s p e c t s that a r e not d e a l t w i t h in h a r m o n i z e d
    standards.
16  Article          22 - Repeal          and      amendment    of     Directives
    D i r e c t i v e 7 6 / 7 6 4 / E E C c o v e r s mer cur y - i n - g I a s s t h e r m o m e t e r s .
     It is an o p t i o n a l D i r e c t i v e . T h e p r o d u c t s and f e a t u r e s
    c o n c e r n e d a r e c o v e r e d by the s c o p e of t h i s d i r e c t i v e .
    T h e a m e n d m e n t of D i r e c t i v e 8 4 / 5 3 9 / E E C r e s t r i c t s its s c o p e        to
    e l e c t r o - m e d i c a l e q u i p m e n t u s e d in v e t e r i n a r y m e d i c i n e .
    E q u i p m e n t u s e d in h u m a n m e d i c i n e is c o v e r e d by t h i s
    p r o p o s a I.
    T h e p u r p o s e of a m e n d i n g D i r e c t i v e 9 0 / 3 8 5 / E E C is to a d d to
    that D i r e c t i v e t h e g e n e r a l p r o v i s i o n s in t h i s p r o p o s a l so as
    to a p p l y t h e m to all m e d i c a l d e v i c e s . T h e e x i s t i n g
    p r o v i s i o n s of D i r e c t i v e 9 0 / 3 8 5 / E E C a r e not a f f e c t e d . T h e
    a m e n d m e n t s w i l l t h e r e f o r e not h a v e any e f f e c t o n t h e
    t r a n s p o s i t i o n of the a b o v e m e n t i o n e d D i r e c t i v e .
17. Article          23 - I m p l e m e n t a t i o n ,   transitional          provisions
    A r t i c l e 2 3 , p a r a g r a p h 4, p r o v i d e s for the o p t i o n a l
    a p p l i c a t i o n of t h e d i r e c t i v e up to J u n e 1 9 9 7 to m e d i c a l
    d e v i c e s w h i c h m u s t u n d e r g o c e r t i f i c a t i o n by a t h i r d p a r t y .
    T h i s p e r i o d is n e c e s s a r y in o r d e r to a v o i d t h e a d d i t i o n a l
    certification workload which would arise with a shorter
    t r a n s i t i o n a l p e r i o d . T o a v o i d the u n n e c e s s a r y r e p e t i t i o n of
    t e s t s a n d v e r i f i c a t i o n s , A r t i c l e 2 3 , p a r a g r a p h 3, s t a t e s
    t h a t t h e n o t i f i e d b o d i e s m u s t t a k e a c c o u n t of t h e r e s u l t s of
    t e s t s a n d v e r i f i c a t i o n s a l r e a d y c a r r i e d out u n d e r p r e -
    existing national regulations.
 ---pagebreak---                                                        - 13 -
18.  Annex        1 - Essential              requirements
     This       Annex        is    largely       based       on   Directive       90/385/EEC.
19.  Annex        8 - Procedures               for     devices      for   special        purposes
     T h e p r o c e d u r e s and s t a t e m e n t s r e f e r r e d to in t h i s A n n e x
     a p p l y to c u s t o m - m a d e d e v i c e s and d e v i c e s i n t e n d e d for
     clinical investigations.                            T h e y are b a s e d o n t h e s o l u t i o n
     a d o p t e d in the C o u n c i l D i r e c t i v e r e l a t i n g to a c t i v e
     implantable medical devices.
2 0. Annex        9 - Classification                    rules
     T h i s A n n e x lays d o w n the r u l e s for the c l a s s i f i c a t i o n of
     m e d i c a l d e v i c e s for the a p p l i c a t i o n of the c o n f o r m i t y
     a s s e s s m e n t p r o c e d u r e s . T h e c o n c e p t of c l a s s i f i c a t i o n is
     e s s e n t i a l l y b a s e d on the v u l n e r a b i l i t y of the h u m a n b o d y
     f o l l o w i n g the u s e of a m e d i c a l d e v i c e .                It a l s o t a k e s
     a c c o u n t of the c o n s e q u e n c e s of f u n c t i o n a l d e f e c t s in m e d i c a l
     devices.             T h e b a s i c c r i t e r i a for the c l a s s i f i c a t i o n r u l e s
     a r e as f o i l o w s :
           c o n t a c t or i n t e r a c t i o n of a d e v i c e w i t h the h u m a n b o d y ;
           c o n t a c t w i t h i n j u r e d skin-,
           the i n v a s i v e n a t u r e of a d e v i c e w i t h r e g a r d to t h e
           o r i f i c e s of the h u m a n b o d y or of a s u r g i c a l d e v i c e ;
            i m p l a n t a t i o n of a d e v i c e in the b o d y ;
           contact with vital o r g a n s (heart, central n e r v o u s
           system) ;
           the d e l i v e r y of e n e r g y or s u b s t a n c e s into or o n t o the
           body .
     O n the a b o v e b a s i s , d e v i c e s w h i c h do not e n t e r into c o n t a c t
     or i n t e r a c t w i t h the b o d y a r e g e n e r a l l y c l a s s i f i e d in C l a s s
     I .
     D e v i c e s which are             i n v a s i v e or i m p l a n t a b l e or w h i c h i n t e r a c t
     w i t h the b o d y a r e           l a r g e l y ( a p a r t from c e r t a i n p a r t i c u l a r
     a s p e c t s ) in C l a s s        M a or         Mb.
 ---pagebreak---                                                    - 14 -
     A s m a l l n u m b e r of d e v i c e s c o n c e r n i n g in p a r t i c u l a r the
     f u n c t i o n s of v i t a l o r g a n s a r e in C l a s s I I I . D e v i c e s w h i c h
     a r e a c t i v a t e d by an e n e r g y s o u r c e and w h i c h in p r i n c i p l e
     s h o u l d be in C l a s s III a r e a l r e a d y c o v e r e d by the D i r e c t i v e
     r e l a t i n g to a c t i v e i m p l a n t a b l e m e d i c a l d e v i c e s . T h e
     p r o v i s i o n s of that D i r e c t i v e c o r r e s p o n d to t h o s e laid d o w n
     for CI a s s I I I d e v i c e s .
21   Annex        10 - C l i n i c a l      evaluation
     A n n e x 1 0 h a s b e e n a d o p t e d f r o m the D i r e c t i v e r e l a t i n g to
     a c t i v e i m p l a n t a b l e m e d i c a l d e v i c e s . It s p e c i f i e s the s u b j e c t
     of t h e c l i n i c a l d a t a and the p r o c e d u r e s to be f o l l o w e d for
     o b t a i n i n g the d a t a . C l i n i c a l e v a l u a t i o n is c a r r i e d out u n d e r
     t h e 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 a y be a f e a t u r e
     r e q u i r e d in the t e c h n i c a l d o c u m e n t a t i o n r e f e r r e d to in the
     conformity assessment procedures.                               The h a r m o n i z e d p r o v i s i o n s
     c o n t a i n e d in t h i s A n n e x w i l l a v o i d r e p e t i t i o n of the s a m e
     c l i n i c a l i n v e s t i g a t i o n s in m o r e t h a n o n e M e m b e r S t a t e .
2 2. A n n e x e s 11 a n d 12 - M i n i m u m           criteria       for  the      notified
     bod i e s . EC m a r k
     These        are   Annexes        typical       of    the n e w   approach         directives.
 ---pagebreak---                                     - 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
 ---pagebreak---                                            - 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
                                              6
  proprietary     medicinal       products* ^,        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.
 ---pagebreak---                                          - 17 -
Whereas,     in   accordance     with   the    principles      set   out    in   the   Council
Resolution      of    7 May 1985     concerning      a    new    approach      to    technical
                                             8
harmonization      and    standardization< ),       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
          9
devices^ ) 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
                                                        1
relating    to electromagmetic        compatibiIity( °),        as   amended    by   Directive
91/263/EEC< 1 D
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.
 ---pagebreak---                                                - 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
                              19
     Decision 90/230/EEC^ ),           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)
 ---pagebreak---                                             -   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
                                                                                           2
 intended    to be used        in the    technical     harmonization        directives^ Dt      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
 ---pagebreak---                                              - 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.
 ---pagebreak---                                            -   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
                  23                                                                 24
thermometers^ ^,          as  last    amended    by   Directive 8 4 / 4 1 4 / E E C ^ ) ;    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
 ---pagebreak---                                        - 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.
 ---pagebreak---                                          -   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.
 ---pagebreak---                                     - 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.
 ---pagebreak---                                          - 25 -
7.     This      Directive        does      not      affect       the     application        of
       Directive 80/836/Euratom, nor of Directive 84/466/Euratom.
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.
 ---pagebreak---                                      -   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.
 ---pagebreak---                                     -  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.
 ---pagebreak---                                       - 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:
 ---pagebreak---                                   - 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.
 ---pagebreak---                                       - 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.
 ---pagebreak---                                       -  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).
 ---pagebreak---                                  - 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
           (Mi)        the  procedure     relating  to    the   EC   declaration   of
                      conformity     set   out   in   Annex 6     (product   quality
                      guarantee).
 ---pagebreak---                                     -  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.
 ---pagebreak---                                     -   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)
 ---pagebreak---                                  - 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.
 ---pagebreak---                                         -   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, M a 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 M a        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.
 ---pagebreak---                                        -   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.
 ---pagebreak---                                        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.
 ---pagebreak---                                        -   39 -
4.      It is prohibited    to affix marks which may be confused with the EC
       mark of conformity.
                                      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.
 ---pagebreak---                                      - 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.
 ---pagebreak---                                      -    41   -
3.   The    following      paragraph         6     is     added     to    Article 1       of
     Directive 90/385/EEC:
            "6.  The     following         provisions        of     Council      Directive
                                26
                 ../.../EEC^ )          [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)
 ---pagebreak---                                        - 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)
 ---pagebreak---                                     - 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.
 ---pagebreak---                                    - 44 -
  II. Requirements regarding design and construction
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.
 ---pagebreak---                                    -   45 -
8.   Infection and microbial contamination
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.
 ---pagebreak---                                          - 46 -
9.2     Devices must be designed and manufactured in such a way as to remove
        or minimize as far as possible:
               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
                      2
         89/617/EEC< >.
 (1)  OJ No L 39, 15.2.1980, p. 40.
 (2)  OJ No L 357, 7.12.1989, p. 28.
 ---pagebreak---                                  _ 47 -
11.  Protection against radiât Ion
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.
 ---pagebreak---                                       - 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.
 ---pagebreak---                                        - 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.
 ---pagebreak---                                         - 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 M a   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)
 ---pagebreak---                                       - 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 M b     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;
 ---pagebreak---                              - 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.
 ---pagebreak---                                    - 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-,
 ---pagebreak---                                    - 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;
 ---pagebreak---                             - 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 ;
 ---pagebreak---                                       - 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.
 ---pagebreak---                                        - 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.
 ---pagebreak---                                      - 58 -
5.   Surveillance
5.1  The aim of surveillance          is to ensure     that   the manufacturer       duly
     fulfils the obligations imposed by the approved quality system.
5.2  The manufacturer 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;
 ---pagebreak---                                    - 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 D D I icat ion to devices in Classes M a and M b
     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  Ma,   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 M a and M b .
 ---pagebreak---                                   - 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;
 ---pagebreak---                                  - 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;
 ---pagebreak---                                       - 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.
 ---pagebreak---                                - 63 -
7.  Administrative provisions
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.
 ---pagebreak---                                    - 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;
 ---pagebreak---                                    - 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.
 ---pagebreak---                                        - 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:
 ---pagebreak---                                   - 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 M a 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 M a    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.
 ---pagebreak---                                 - 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-,
 ---pagebreak---                                    - 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.
 ---pagebreak---                                    - 70 -
    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 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.
 ---pagebreak---                                     - 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.
 ---pagebreak---                                       - 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 M a
         In line with Article 11(2),        this Annex may apply         to products in
        Class M a , subject to these derogations:
 ---pagebreak---                                 - 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 M a   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.
 ---pagebreak---                                   - 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;
 ---pagebreak---                                     - 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.
 ---pagebreak---                                      - 76 -
    It shall include in particular an adequate description of:
           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.
 ---pagebreak---                                     - 77 -
4.  Survelllance
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.
 ---pagebreak---                                 - 78 -
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   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 M a
     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 M a   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.
 ---pagebreak---                                 - 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.;
 ---pagebreak---                                     - 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.
 ---pagebreak---                                     - 81     -
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 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.
 ---pagebreak---                                    - 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-,
 ---pagebreak---                                   - 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.
 ---pagebreak---                             - 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.
 ---pagebreak---                                     - 85 -
                                                                 ANNEX 9
                             CLASSIFICATION CRITERIA
   I. CLASSIFICATION P U U S
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 M a
             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 .
 ---pagebreak---                                       - 86    -
1 .4  Rule 4
      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 M b    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          Ma.
 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 M a     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 M a or a higher class, are in
               Class  Ma.
  2.2   Rule 6
        All  surgically   invasive devices       intended   for transient      use are     in
        Class M a unless they are:
 ---pagebreak---                                      - 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 M a 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.
 ---pagebreak---                                     - 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 M a    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   Mb.    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           Mb.
 3.2  Rule 10
      All active devices intended for diagnosis are in Class           Ma:
              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.
 ---pagebreak---                                 - 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     Mb.
 ---pagebreak---                                 - 90 -
II. DEFINITIONS AND IMPLEMENTING RULES
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.
 ---pagebreak---                                    - 91 -
1.4  Active medical
     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.
 ---pagebreak---                                - 92 -
2.  IMPLEMENTING RULES
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.
 ---pagebreak---                                    - 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.
 ---pagebreak---                                         - 94 -
2.2     Ethical considerations
        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.
 ---pagebreak---                                 - 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.
 ---pagebreak---                                   - 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.
 ---pagebreak---                                - 97 -
4. The inspection staff must have:
          sound  vocational  training  covering   all  the assessment  and
          verification   operations   for   which    the  body  has   been
          designated;
          satisfactory knowledge of the rules on the inspections which
          they carry out and adequate experience of such inspections;
          the ability required to draw up the certificates, records and
          reports to demonstrate that the inspections have been carried
          out.
5. The impartiality of the inspection staff must be guaranteed. Their
   remuneration must not depend on the number of inspections carried
   out, nor on the results of the inspections.
6. The body must take out civil liability insurance, unless liability
    is assumed by the State under 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.
 ---pagebreak---       - 98 -
                      ANNEX 12
CE MARK OF CONFORMITY
 ---pagebreak---                                        - 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,
 ---pagebreak---                                                    - 100 -
                  é t a b I i s s e m e n t et g e s t i o n d'un s y s t è m e d ' a l e r t e
                  p e r m e t t a n t au x E t a t s m e m b r e s de p r e n d r e d e s m e s u r e s
                  de p r o t e c t ion s u i t e à d e s i n c i d e n t s i n d é s i r a b l e s
                   i n t e r v e n u s av ec des d i s p o s i t i f s ,
                  é I a b o r a t i on p ar la C o m m i s s i o n des l i g n e s d i r e c t r i c e s
                  u t i l e s à I'a p p l i c a t i o n u n i f o r m e de la d i r e c t i v e
                  p o r t a n t sur s on champ d ' a p p l i c a t i o n a i n s i q u e sur la
                  c I a s s i f i cat io      n des d i s p o s i t i f s ,
                  g e s t i on des pr o c é d u r e s c o n c e r n a n t la c l a s s i f i c a t i o n
                  d e s d i spos i t fs        i et l ' a p p l i c a t i o n de la c l a u s e de
                  s a u v e g a r d e im p l i q u a n t le r e c o u r s à l ' a v i s t e c h n i q u e
                  d e s e x p e r ts ,
                  m i s e en pi ace d ' u n e b a s e e u r o p é e n n e de d o n n é e s
                  p o r t a n t sur I a c e r t i f i c a t i o n des d i s p o s i t i f s , la
                  c l a s s i f i c a t i o n et les i n c i d e n t s n o t i f i é s d a n s le
                  c a d r e du syst ème d ' a l e r t e .
4.2.        D u r é e : e n v i r o n 4-5 a n s ; a c t i o n p o n c t u e l l e . Le m o n t a n t
            d e s c r é d i t s a l l o u é s pour c e t t e a c t i o n s e r a t o u t e f o i s
            d é t e r m i n é c h a q u e a n n é e en f o n c t i o n des t r a v a u x r e s t a n t à
            ef f e c t u e r .
4.3.        Population              concernée : potentiellement, l'ensemble                         de    la
            population              c o m m u n a u t a i r e et des p a y s t i e r s .
Classification                  des     dépenses
5.1.        Dépenses            non     obligatoires
5.2.         . B5-300 : crédits                      dissociés
             . B8-530 : crédits                      non d i s s o c i é s
Nature        des       dépenses
L ' é l a b o r a t i o n des n o r m e s h a r m o n i s é e s par le C E N / C E N E L E C est
c o u v e r t e par une c o n t r i b u t i o n f i n a n c i è r e de la C o m m u n a u t é et
l'AELE (part du f i n a n c e m e n t i n c o m b a n t à la CE .- 8 6 % , à
l'AELE : 1 4 % ) . Les f r a i s r e s t a n t s e r o n t c o u v e r t s par les
o r g a n i s m e s de n o r m a l i s a t i o n et les p a r t i e s c o n c e r n é e s
( i n d u s t r i e , o r g a n i s m e s de c e r t i f i c a t i o n e t c ) .
Le f i n a n c e m e n t sera o c t r o y é m o y e n n a n t des b o n s de c o m m a n d e
p a s s é s en v e r t u du c o n t r a t - c a d r e du 4 août 1 9 8 9 s i g n é a v e c                le
CEN/CENELEC.
La m i s e en p l a c e d'une base de d o n n é e s n é c e s s i t e r a un
f i n a n c e m e n t s o u s forme d ' é t u d e de f a i s a b i l i t é et de p r e s t a t i o n
de s e r v i c e s au c o u r s de la p h a s e de d é m a r r a g e .
La f o u r n i t u r e des a v i s t e c h n i q u e s n é c e s s a i r e s en vue des
q u e s t i o n s s p é c i f i q u e s d a n s le c a d r e de la g e s t i o n c o u r a n t e
s e r a f i n a n c é e par des c o n t r a t s d ' é t u d e et de p r e s t a t i o n de
service.
 ---pagebreak---                                   - 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 d e 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               Crédits de pa i ement
                    (1.000 ECU)                         (1.000 ECU)
      1992             1 .500                                1 .000
      1993             4.000                                 2.000
      1994             5.000                                 4.000
      1995             4.500                                 5.000
      1996             p.m.                                  3.000
                       15.000                               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
                                                             ECU
          1992          30 x  450 ECU                        13  500
          1993          30 X  450 ECU                        13  500
          1994          30 x  450 ECU                        13  500
          1995          20 x  500 ECU                        10  000
          1996          20 x  500 ECU                        10  000
                                   TOTAL  (1992-1996)        60.500
 ---pagebreak---                                                - 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 :
                                                                                    ECU
               * 1992                                                           200.000
               * 1993                                                           200.000
               * 1994                                                           100.000
                                               TOTAL (1992-1994)                500.000
8.       Dispositions            anti-fraude   prévues dans  la p r o p o s i t i o n  d'action?
         Le c o n t r a t - c a d r e visé sous le point 6. prévoit un
         échelonnement des paiements en fonction des p r o g r è s 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 E S 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 o n
allocation ressources dans le cadre de la procédure b u d g é t a i r e , I Is
sont e s t i m é s , pour l'unité III.D.4, à partir de 1992 à :
                                - 1 A
                                - 1 B
soit environ 200.000 ECU, à raison de 100.000 ECU en m o y e n n e par
personne et par an.
VOLET 3 : E L E M E N T S D'ANALYSE           COUT-EFFICACITE
1.        O b j e c t i f s et cohérence avec      ia programmation      financière
          La d i r e c t i v e 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 e s fait partie de l'action pluriannuelle de la
          C o m m i s s i o n 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.
 ---pagebreak---                                          - 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 o n d e s 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 é s d e s 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 u x 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 .
 ---pagebreak---                                                            - 104 -
                                        Fiche      d'évaluation           d'impact
                Impact de la p r o p o s i t i o n sur les e n t r e p r i s e s e t , en
              p a r t i c u l i e r , sur les p e t i t e s et m o y e n n e s e n t r e p r i s e s
 TITRE       DE LA         PROPOSITION
 P r o p o s i t i o n de d i r e c t i v e c o n c e r n a n t le r a p p r o c h e m e n t d e s
 l é g i s l a t i o n s d e s E t a t s m e m b r e s r e l a t i v e s aux d i s p o s i t i f s
 méd i e a u x .
 NUMERO        DE R E F E R E N C E       DU    DOCUMENT
 2121.21
 LA     PROPOSITION
.1.        C o m p t e t e n u du p r i n c i p e de s u b s i d i a r i t é , p o u r q u o i une
            l é g i s l a t i o n c o n m u n a u t a i re e s t - e l l e n é c e s s a i r e d a n s ce
           d o m a i n e et q u e l s sont ses p r i n c i p a u x o b j e c t i f s ?
           L e s r é g l e m e n t a t i o n s n a t i o n a l e s r e l a t i v e s à la m i s e sur le
           m a r c h é et la m i s e en s e r v i c e d e s d i s p o s i t i f s m é d i c a u x
           p r é s e n t e n t un tel d e g r é de d i v e r g e n c e s s u b s t a n t i e l l e s ,
           q u ' u n e libre c i r c u l a t i o n d a n s la C o m m u n a u t é n ' e s t p a s
           a s s u r é e . L ' h a r m o n i s a t i o n d e s e x i g e n c e s et d e s p r o c é d u r e s
           d ' é v a l u a t i o n de la c o n f o r m i t é a u x q u e l l e s d o i v e n t r é p o n d r e
            les d i s p o s i t i f s m é d i c a u x p o u r a s s u r e r la p r o t e c t i o n d e s
           p a t i e n t s , u t i l i s a t e u r s et t i e r s e s t , d è s l o r s , le seul m o y e n
           p o u r a c h e v e r le m a r c h é i n t é r i e u r d a n s ce s e c t e u r .
  IMPACT        SUR     LES      ENTREPRISES
 2.         Qui     sera       affecté         par   la    proposition?
                  s e c t e u r s d ' e n t r e p r i s e s : tout f a b r i c a n t de d i s p o s i t i f s
                  m é d i c a u x (à l ' e x c e p t i o n d e s d i s p o s i t i f s       implantables
                  a c t i f s , t e l s que d e s s t i m u l a t e u r s c a r d i a q u e s a i n s i q u e
                  d e s d i s p o s i t i f s d e s t i n é s au d i a g n o s t i c       in-vitro),
                  exemples : appareils électromédicaux, produits à usage
                  u n i q u e , m a t é r i a u x et p r o t h è s e s d e n t a i r e s , p r o t h è s e s
                  o r t h o p é d i q u e s , i n s t r u m e n t s , etc
                  t a i l l e s des e n t r e p r i s e s : toute           taille,         y compris      les
                  m u l t i n a t i o n a l e s et le.s PME
                  zones        géographiques            particulières           d'implantation           : aucune
 ---pagebreak---                                                - 105 -
Q u e l l e s m e s u r e s les e n t r e p r i s e s       d e v r o n t - e I I es  prendre       pour
se c o n f o r m e r à la p r o p o s i t i o n ?
A p a r t i r de l ' a p p l i c a t i o n t o t a l e de la d i r e c t i v e , c ' e s t - à -
d i r e le 1er J u i l l e t 1 9 9 7 :
       la c o n c e p t i o n et la f a b r i c a t i o n d e s p r o d u i t s d e v r o n t
       r é p o n d r e aux e x i g e n c e s de la d i r e c t i v e ,
       les f a b r i c a n t s o u l e u r s m a n d a t a i r e s d e v r o n t s u i v r e les
      p r o c é d u r e s d ' é v a l u a t i o n de c o n f o r m i t é p r é v u e s .
A u c o u r s d ' u n e p é r i o d e de t r o i s a n s à p a r t i r d e la p r e m i è r e
a p p l i c a t i o n de la d i r e c t i v e ( e n t r e J u i n 1 9 9 4 et J u i n 1 9 9 7 ) ,
les f a b r i c a n t s p o u r r o n t , soit c o n t i n u e r à a p p l i q u e r les
l é g i s l a t i o n s n a t i o n a l e s p r é e x i s t a n t e s , s o i t s e c o n f o r m e r au
rég ime h a r m o n i s e .
Q u a n t aux p r o c é d u r e s d ' é v a l u a t i o n de c o n f o r m i t é , les
f a b r i c a n t s p o u r r o n t c h o i s i r , en c a s d ' i n t e r v e n t i o n d ' u n e
t i e r c e p a r t i e , e n t r e trois ou q u a t r e p r o c é d u r e s
alternativement applicables.
L e s d i s p o s i t i o n s t r a n s i t o i r e s a i n s i q u e le c h o i x p o u r les
f a b r i c a n t s e n t r e p l u s i e u r s p r o c é d u r e s d ' é v a l u a t i o n de la
c o n f o r m i t é d e v r o n t f a c i l i t e r la t r a n s i t i o n v e r s le r é g i m e
harmon i se.
Quels effets                économiques          a proposition               est-elle      susceptible
d'avoir?
      sur       I'emplo i : aucun             effet     significatif             n'est     escompté.
      s u r les i n v e s t i s s e m e n t s et la c r é a t i o n de n o u v e l l e s
      e n t r e p r i s e s : la d i r e c t i v e peut a v o i r c o m m e e f f e t ,
      n o t a m m e n t en ce qui c o n c e r n e les d i s p o s i t i f s m é d i c a u x
      p r é s e n t a n t un r i s q u e é l e v é , q u ' u n e p a r t i e d e s e n t r e p r i s e s
      d o i v e n t a d a p t e r l e u r s p r o c é d é s de f a b r i c a t i o n , de s o r t e à
      p e r m e t t r e u n e q u a l i t é de p r o d u c t i o n é l e v é e et c o n s t a n t e .
      O r , c e s i n v e s t i s s e m e n t s r e n f o r c e r o n t la c o m p é t i t i v i t é d e s
      ent repr i s e s .
      s u r la c o m p é t i t i v i t é d e s e n t r e p r i s e s : l ' a c t i o n p r o p o s é e
       f a c i l i t e r a l ' a c c è s à un m a r c h é de d i m e n s i o n
      c o m m u n a u t a i r e . C e t t e p e r s p e c t i v e o u v r i r a de n o u v e a u x
      h o r i z o n s aux e n t r e p r i s e s de t a i l l e p l u s m o d e s t e qui ne
      d i s p o s e n t p a s de f i l i a l e s d a n s c h a q u e E t a t m e m b r e p o u r
       t r a i t e r d i r e c t e m e n t a v e c les a u t o r i t é s n a t i o n a l e s
      c o m p é t e n t e s . Il faut é g a l e m e n t s o u l i g n e r q u e les
      e n t r e p r i s e s d e v r o n t , de ce f a i t , f a i r e f a c e à u n e
       i n t e n s i f i c a t i o n de la c o n c u r r e n c e .
La p r o p o s i t i o n c o n t i e n t - e l l e des m e s u r e s v i s a n t à t e n i r
c o m p t e de la s i t u a t i o n s p é c i f i q u e des p e t i t e s et m o y e n n e s
e n t r e p r ises?
Non
 ---pagebreak---                                - 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 n s et
     des   pharmaciens.
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 .
 ---pagebreak---                                                                     ISSN 0254-1475
                                                              COM(91) 287 final
                                                     DOCUMENTS
EN                                                                             06
                                 Catalogue number : CB-CO-91-356-EN-C
                                                             ISBN 92-77-74963-6
Office for Official Publications of the European Communities
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