Amended proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices
Date: 1998-10-02
Institutions: European Commission
Subjects: disease prevention, harmonisation of standards, marketing standard, medical device, medical diagnosis

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 02.10.1998 

COM(1998) 548 final 

95/0013 (COD) 

OPLNION OF THE COMMISSION 
pursuant to Article  189 b (2) (d) of the EC Treaty, 
on the European  Parliament's  amendments 
to the Council's common position  regarding the 

proposal  for a 
EUROPEAN  PARLIAMENT AND COUNCIL DIRECTIVE 

on in vitro diagnostic medical  devices 

AMENDING THE PROPOSAL OF THE COMMISSION 
pursuant to Article  189 a (2) of the EC Treaty 

1. BACKGROUND 

a) 

Objective  of the proposal 

The proposal  for a directive, based  on Article  100a of the Treaty,  is intended  to 
harmonise national  provisions applicable to the placing on the market  of in vitro 
diagnostic  medical  devices. It lays down  the requirements to be met by the 
products with regard  to protecting the health and safety  of patients, users and third 
parties; the conditions governing their placing on the market  and  aspects 
concerning checks on products already on the market. Article 21 also provides  for 
a number of amendments  to Directive 93/42/EEC on medical devices, to include 
devices manufactured  using human  tissues in the scope of  Directive 93/42/EEC, 
and to bring Directive 93/42/EEC  more closely  into line with the Directive on in 
vitro diagnostic devices. 

Date of the submission  of the proposal  to the Council  (document COM(95)130 
final-95/0013  (COD)):  19 April  1995 

Opinion  of the  Economic  and Social  Committee: 25 October  1995 

Date of the European  Parliament's opinion  on first reading:  14 March  1996 

Date of the adoption  of the common  position  : 23 March  1996 

Date of the presentation  of an amended Commission  proposal  (document 
COM(96)643  final):  20 December  1996 

Commission  communication  to the European  Parliament  pursuant  to Article 
189b(2) (document  SEC(1998) 555 final): 26 March  1998 

b) 

c) 

d) 

e) 

f) 

g) 

h) 

Date of the European  Parliament's decision  on second reading:  18 June  1998 

2. 

POSITION OF THE EUROPEAN  PARLIAMENT 

At its plenary session  in June  1998, the European  Parliament  adopted  6 amendments  to 
the Council common  position. These are intended to: 

emphasise the need  to notify  the competent  authorities of the placing on the 
market of new products, such as DNA micro-chips  (amendment  1, Recital  29a) 

insist on the need for Community  legislation  on medical  devices  manufactured 
using human tissues or cells (amendment 2,  Recital  33a); 

clarify  that  the  option  for  Member  States  to  demand  supplementary  information 
for  certain  medical  devices  is not a  precondition  for  the placing  on  the  market  or 
putting  into  service  of  in  vitro diagnostic  medical  devices  (amendment  3,  Article 
10(2), second  subparagraph); 

2^ 

oblige  manufacturers  to  translate  the  label  and  the  instructions  for  use  of  the  self-
testing  devices  into  one  or  more  of  the  languages  of  the  Member  State  where  the 
in  vitro  diagnostic  medicd  device  reaches  its  final  user  (amendment  4,  Annex  I, 
(B)(8. J), fifth  paragraph  a); 

oblige  manufacturers  to  submit  the  tests  used  for  evaluating  the  risk  of  trisomy  21 
(Down's  Syndrome  in  the  foetus)  to  certification  by  a  third  party  (amendment  5, 
Annex  II, List  B, seventh  indent  a); 

emphasise,  with  regard  to  diagnosis,  the  primary  importance  of  protecting  the 
confidentiality  of  the  information  obtained  and  the  principle  of  non-discrimination 
on 
the  person  being  examined 
(amendment  6,  Article  1(4)). 

the  genetic  characteristics  of 

the  basis  of 

3. 

OPINION  OF THE  COMMISSION 

The  Commission  is able  to  accept  the  amendments: 

amendment  1  because  the  new  recital  relates  to  the  notification  procedure  for 
"new  products"  provided  for  under  Article  10(4),  and  gives  an  important  example 
of  the  application  of  that  Article; 

legislation  on  medical  devices  manufactured 

amendment  2  because  the  recital  recalls  the  need,  recognised  by  the  Member 
States,  for  harmonised 
from 
.substances  of  human  origin.  In  addition  to  the  essential  pari  on  m  vitro  diagnostic 
medical  devices,  the  Commission  proposal  (COM(95)  130  final)  provided  for  the 
inclusion  of  devices  incorporating  substance:-;  of  human  origin  in  the  scope  of 
Directive  93/42/EEC  on  medical  devices.  This  pari  was  separated  from  thai 
relating  to  in  vitro  diagnostic  devices  and  is  still  before  the  Council  for  a  first 
reading; 

amendment  3  because  it  clarifies  the  interpretation  that  should  be  gwen  to  the 
procedure  according  to  which  Member  Stales  may  request  information  regarding 
the  labelling  and  the  instructions  for  ust-  of  certain  products.  The  addition  is 
useful,  as 
those 
it  prohibits  supplementary  national  procedures  other 
provided  for  in  the  Directive  on  the  placing  on  the  market  of  in  vitro  diagnostic 
medical  devices. 

than 

amendment  4  because  it  adds  a useful  clarification  with  regard  to  the  extent  of  the 
labelling  obligations  for  self-testing  devices,  in  accordance  with  the  principle 
already  included  in  Article  4(4); 

amendment  5 because  the  extension  of  certification  obligations  by  a  third  part)  to 
tests  designed  to  assess  the  risk  of  trisomy  2i  (Downs  Syndrome)  in  the  foetus  is 
justified,  as  it  is necessary  to ensure  a very  high  level  of  quality  ol'devices  as  false 
positive  results  from  the  tests  have  serious  consequences  for  the  patient  and  (he 
foetus; 

2> 

amendment  6 because  it restates the rights set out  in the European  Convention  for 
the  Protection  of  Human  Rights  and  Fundamental  Freedoms  with  regard  to  the 
applications of biology and medicine referred  to in Article  I (4). 

For these reasons, and pursuant  to Article  189a of the EC Treaty, the Commission  has 
decided  to amend  its proposal  to incorporate the 6 amendments  adopted  by the European 
Parliament. 

^ 

Amended  proposal for a 

European  Parliament  and Council  Directive 

on in vitro diagnostic  medical  devices 

(presented  by the Commission  pursuant to Article  189a(2) of the EC Treaty) 

Common  position  of  the 
Common  position  of  the 
Council 
Council 

Modified  proposal 
Modified-proposal 

Recital  29a  (new) 
Recital  29a  (new) 

notify 
notify 

authorities 
authorities 

{29a)  Whereas  il  is  essential_that 
{29a)  Whereas  it  is  essentiai_that 
the 
manufacturers 
the 
manufacturers 
the 
conjgejgm 
the 
of 
of 
conjgejgm 
'new 
placing  on  the  market  of 
placing  on  the  market  of  View 
products'  with  regard  both  to  the 
•products'  with  regard  both  to  the 
technology 
the 
used 
technology 
the 
used 
substances  to be  analysed  or  other 
substances  to he  analysed  or  other 
in 
this 
parameters; 
in 
this 
parameters; 
particular  of  high-density  DNA 
particular  of  high-density  DNA 
probe  devices  (known  as  micro-
probe  devices  (known  as  micro-
ghiosjused  in^gejieiiçjiCjgejùng, 
ghiosjused  In^gejieiicjiCjggnmg, 

true 
true 

and 
and 

is 
is 

Recital  33a  (new) 
Recital  33a  (new) 

Article  1(4; 
Article  1(4; 

(33a)  Whereas  it  is  necessary  to 
(33a)  Whereas  it  is  necessary  to 
draw  up  as  quickly  as  possible 
draw  up  as  quickly  as  possible 
is  lacking 
the  legislation  which 
is  lacking 
the  legislation  which 
on  medical  devices  manufactured 
on  medical  devices  manufactured 
using 
of.  human 
using 
human 
of. 
origin; 
origin; 

substances 
substances 

and 
and 

substances 
substances 
shall 
shall 
relation 
relation 

this 
this 
the  purposes  of 
the  purposes  of 
For 
For 
Directive, 
removal, 
removal, 
the 
the 
Directive, 
collection  and  use  of  tissues, 
collection  and  use  of  tissues, 
of 
ceiis 
of 
ceiis 
be 
origin 
origin 
human 
be 
human 
governed, 
to 
to 
governed,  m 
in 
ethics,  by  the  principles  Said 
ethics,  by  the  principles  Said 
down  in  the  Convention,  of 
down  in  the  Convention  of 
the  Council  of  Europe  for  the 
the  Council  of  Europe  for  the 
protection  of  human 
rights 
rights 
protection  of  human 
the  human 
and  dignity  of 
the  human 
and  dignity  of 
the 
to 
being  with 
the 
to 
being  with 
application  of  biology  and 
application  of  biology  and 
medicine  and  by  any  Member 
medicine  and  by  any  Member 
States' 
this 
States' 
this 
matter. 
matter. 

regulations  on 
regulations  on 

regard 
regard 

of 
of 

the 
the 

this 
this 
purposes 
purposes 
For 
For 
Directive,  the  removal,  collection 
Directive,  the  removal,  collection 
and  use  of 
tissues,  cells  and 
tissues,  cells  and 
and  use  of 
substances  of  human  origin  shall 
substances  of  human  origin  shall 
be  governed,  in  relation  tc  ethics, 
be  governed,  in  relation  to  ethics, 
by  the  principles  laid  down  in  the 
by  the  principles  laid  down  in  the 
Convention  of 
the  Council  of 
Convention  of 
the  Council  of 
the  protection  of 
the  protection  of 
Europe 
Europe 
human  rights  and  dignity  o\  the 
human  rights  and  dignity  oï  the 
human  being  with  regard  to  the 
human  being  with  regard  to  the 
application 
and 
application 
and 
medicine  and  by  any  Member 
medicine  and  by  any  Member 
States'  regulations  on  this  matte.»". 
States"  regulations  on  this  matte.»". 

biology 
biology 

for 
for 

of 
of 

•M 
mm^^k^É^s*!^^^ 
mm^^k^É^s*!^^^ 
•M 
.?l_Jiie_ j:pnfLd?ji tïaiity__. of _ data 
.?l_Jiie_ j:pnfLd?ji tïaiity__. of. __ data 
^Mits.„i2_jiàyyte...JitçLJAiî4...:^ 
principle  of  non-discrimination 
principle  of  non-discrimination 

Article  10(2), second 
subparagraph  (new) 

Annex  l,(B)(8.l), 
5lh subparagraph a 
(new) 

Annex  II, List B, 
7th indent a (new) 

on  grounds  of  human  inherited 
genetic  characteristics  shall  be 
paramount. 

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

The  decision  whether  to  translate 
the  instructions  for  use  and  the 
label  into  one  or  more  languages 
of  the  European  Union  shall  be 
left  to  the  Member  States,  except 
that,  for  self-testing  devices,  the 
instructions  for  use  and  the  label 
shall  include a translation  into the 
the 
official 
language(s) 
Member  State 
the 
device  for  self-testing  reaches  its 
final  user. 

of 
in  which 

Reagents  and  reagent  products, 
including 
calibrators, 
related 
control  materials  and  software, 
designed 
for 
evaluating the risk of trisomy  21. 

specifically 

ISSN 0254-1475 

COM(98) 548  final 

DOCUMENTS 

EN 

15  05  16  01 

Catalogue  number  :  CB-CO-98-550-EN-C 

ISBN  92-78-39453-X 

Office  for Official  Publications of the European  Communities 

L-2985 Luxembourg 

%