Commission communication on the application of the transitional provisions of Directive 93/42/EEC relating to medical devices
Date: 1998-08-01
Institutions: European Commission
Subjects: disease prevention, health control, marketing, medical device, occupational health, occupational safety

1.8.98

EN

Official  Journal  of  the  European  Communities

C  242/5

Commission  communication  on  the  application  of  the  transitional  provisions  of  Directive
93/42/EEC  relating  to  medical  devices

(98/C  242/05)

This  communication  refers  to  Article  22(4)  of  Directive
93/42/EEC  concerning  medical  devices.  It  aims  at
providing  clarification  on  the  aformentioned  provision  in
order  to  ensure  its  uniform  application  throughout  the
European  Community.

Article  22(4)  of  Directive  93/42/EEC  requires  Member
States  to  continue  to  accept  the  placing  on  the  market
and  the  putting  into  service  of  devices  which  conform  to
the  rules  in  force  in  their  territory  on  31  December  1994
pre(cid:220)existing  national  rules)  for  a  period  of  five  years
following  the  adoption  of  the  aforementioned  Directive,
i.e.  ending  on  14  June  1998.

Accordingly,  since  1  January  1995,  when  Directive
93/42/EEC  became  first  applicable,  it  has  been  possible
to  place  medical  devices  on  the  market  and  put  them  into
the  pre(cid:220)existing
in  accordance  with 
service  either 
national 
compliance  with  Directive
93/42/EEC.  From  15  June  1998,  it  will  only  be  possible
to  place  medical  devices  on  the  market  and  put  them  into
service  if  they  comply  with  Directive  93/42/EEC.

rules  or 

in 

The  term  "placing  on  the  market’  is  defined  in  Article
1(2)(h)  of  Directive  93/42/EEC  as  the  "first  making
available  in  return  for  payment  or  free  of  charge  of  a
device  .(cid:216).(cid:216).  with  a  view  to  distribution  and/or  use  on  the
Community  market  regardless  of  whether  it  is  new  or
fully 
in
accordance  with  Article  1(2)(i),  "the  stage  at  which  a
device  is  ready  for  use  on  the  Community  market  for  the
first  time  for  its  intended  use’.  The  concepts  of  placing
on  the  market  and  putting  into  service  refer  to  each  indi(cid:220)
vidual  product,  and  not  to  a  type  of  device.

service’  means 

refurbished’. 

"Putting 

into 

The  provision  of  Article  22(4)  applies  in  relation  to
devices  placed  on  the  market  prior  to  15  June  1998  in
compliance  with 
the  pre(cid:220)existing  national  rules  of
Member  States.  Member  States  may  require  evidence  on
compliance  with  such  rules  and,  where  no  specific  rules
exist,  on  the  assurance  of  an  adequate  level  of  safety  of
devices  based  on  general  safety  considerations.

To  a 
large  extent,  devices  covered  by  Directive
93/42/EEC  are  ready  for  use  at  the  time  they  are  placed
on  the  market  by  the  manufacturer.  In  fact,  distribution
or  other  manipulations  make  no  difference  to  their  safety
and  performance,  provided  manufacturers’  instructions
have  been  followed.  These  devices  are  considered  as
being  put  into  service  at  the  same  time  as  they  are  placed
on  the  market.  Therefore,  such  devices  which  have  been
made  available  by  the  manufacturer  up  to  and  including
14  June  1998  may,  after  that  date,  continue  to  be  trans(cid:220)
ferred 
in  accordance  with
pre(cid:220)existing  national  rules.

to  end(cid:220)users  and  used 

Some  devices,  prior  to  their  use,  need  further  processing,
for 
instance  sterilisation  of  surgical  dressings,  prep(cid:220)
aration  of  dental  filling  material,  soaking  and  fitting  of
contact  lenses.  Such  kind  of  processing  by  the  end(cid:220)user,
according  to  its  needs,  is  assigned  to  products  by  the
manufacturer  as  part  of  the 
intended  use.  Relevant
devices  should  be  considered  as  being  ready  for  use,  even
if  the  aforementioned  processing  by  the  end(cid:220)user  has  not
yet  taken  place.

However,  devices  placed  on  the  market  which,  in  view
of  their  first  use,  need  to  be  assembled  or  installed  in  the
hospital  and  where  these  manipulations  have  an  impact
on  safety  and/or  performances  of  the  devices,  are  not
considered  as  "put  into  service’,  unless  the  aforemen(cid:220)
tioned  activities  have  been  carried  out.

It  should  be  noted  that  Article  22(4)  as  well  as  the  defi(cid:220)
nition  of  "putting  into  service’  within  the  meaning  of
Directive  93/42/EEC  are  currently  under  revision(cid:216)(˛).
Once  the  forthcoming  amendment  of  Article  22(4)  which
is  currently  going  through  the  legislative  procedure  will
become  applicable,  the  present  interpretation  will  cease
to  apply.

Regarding  the  "putting  into  service’  of  those  devices,  the
Commission  considers  that  a  device  reaches  this  stage  as
soon  as  it  is  ready  for  use  in  the  Community.

(˛)(cid:217)See  Article  21(2)(g)  of  the  common  position  adopted  by  the
Council  on  23  March  1998  with  a  view  to  adopting
Directive  98/.(cid:216).(cid:216)./EC  of  the  European  Parliament  and  the
Council  on  in(cid:220)vitro  diagnostic  medical  devices.