12. 2. 75 Official  Journal  of the  European  Communities No C 33/5 
II 
(Preparatory  Acts) 
COMMISSION 
Proposals  for Council  Directives: 
I. on the approximation  of the  laws  of the  Member  States  relating  to electromedical 
equipment 
II. on the approximation  of the  laws  of the  Member  States  relating  to medical  X-ray 
equipment  operating  at 10 to 400  kV 
(Submitted  to the Council  by the Commission  on  31 December  1974) 
I 
Proposal  for a Council  Directive  on the approximation  of the  laws  of Member  States 
relating  to electromedical  equipment 
THE  COUNCIL  OF  THE  EUROPEAN 
COMMUNITIES, 
Having  regard  to  the  Treaty  establishing  the 
European  Economic  Community,  and  in particular 
Article  100  thereof; 
Having  regard  to the proposal  from  the Commission; 
Having  regard  to the  Opinion  of the  European 
Parliament; 
Having  regard  to the Opinion  of the Economic  and 
Social  Committee; 
Whereas,  in each  Member  State,  electromedical 
appliances  must  satisfy  a high  and  clearly-defined 
standard  of safety  both  for  the  users  of such 
equipment  and  for  those  receiving  treatment  by 
means  of the equipment; 
Whereas  several  Member  States  have  sought  to 
ensure  that  standard  of  safety  by  mandatory 
specifications  relating  both  to the  technical  safety regulations  and  the  inspection  procedures,  and 
whereas  those  specifications  vary  from  one  Member 
State  to another, 
Whereas  those  impediments  to the establishment  and 
operation  of the common  market  can  be reduced  or 
eliminated  if the same  specifications  are adopted  by 
all the  Member  States,  either  in addition  to or in 
place  of their  present  legislation, 
Whereas  it is expedient  in the  first  instance  to 
harmonize  at Community  level  one  section  of 
electromedical  equipment;  whereas  the  most 
adequate  form  of harmonization  is by reference  to 
the standards  drawn  up  by  the  International 
Electrotechnical  Commission; 
Whereas,  in order  to ensure  that  the  equipment 
complies  with  the  harmonized  standards,  the 
manufacturer  acknowledges  his  responsibility  by a 
mark  or declaration  of conformity; 
Whereas  technological  progress  requires  prompt 
adaptation  of the  technical  specifications  laid  down 
No C 33/6 Official  Journal  of the  European  Communities 12. 2. 75 
by the  Directives  with  respect  to electromedical 
equipment;  whereas,  in order  to  facilitate  the 
implementation  of the  measures  required,  provision 
must  be made  for  a procedure  establishing  close 
cooperation  between  the  Member  States  and  the 
Commission  within  the Committee  on the Adaptation 
to Technical  Progress  of the  Directives  on  the 
Removal  of  Technical  Barriers  to  Trade  in 
Electromedical  Equipment; 
Whereas  it could  happen  that  electrical  equipment 
used  in medicine  although  conforming  to the 
provisions  of this  Directive  and  its Annexes,  endanger 
public  health;  whereas  it is, therefore,  advisable  to 
provide  a procedure  intended  to remove  this  danger, 
HAS  ADOPTED  THIS  DIRECTIVE: 
Article  1 
This  Directive  shall  apply  to  electromedical 
equipment  (hereinafter  called  'equipment')  used  in 
human  or veterinary  medicine,  with  the exception  of 
the equipment  listed  in the Annex. 
Article  2 
1. Member  States  may  not  on grounds  of safety 
requirements  prohibit  the sale,  free  movement  or use 
of equipment  coming  within  Article  1 of this 
Directive  if its  conformity  with  the  harmonized 
standards  is attested  by a mark  of conformity  affixed 
to it or by a declaration  of conformity  issued  by the 
manufacturer. 
2. For  the  purposes  of this  Directive,  the  term 
'harmonized  standards'  shall  be taken  to refer  to the 
requirements  set  out  in the  'recommendations  for 
general  safety  requirements  for  electrical  equipment 
used  in medical  practice'  IEC  draft  recommendations 
62A (Secretariat)  10 of 
Article  3 
Every  Member  State  shall  ensure  that  medical 
expenses  incurred  in connection  with  the  use  of 
equipment  complying  with  the  prescriptions  of this 
Directive  qualify  for  reimbursement  on the  same 
terms  as expenses  incurred  in connection  with  the use 
of equipment  complying  with  the  requirements  in 
force  within  its territory. 
Article  4 
Any amendments  required  to adapt  the harmonized 
standards  to technical  progress  shall  be adopted  in 
accordance  with  the procedure  laid  down  in Article  6. Article  5 
1. A  Committee  on the  Adaptation  to Technical 
Progress  of the  Directives  on  the  Removal  of 
Technical  Barriers  to  Trade  in  Electromedical 
Equipment  (hereinafter  called  'the  Committee'),  is 
hereby  set up; it shall  consist  of representatives  of the 
Member  States,  with  a representative  of  the 
Commission  as chairman. 
2. The  Committee  shall  adopt  its own  rules  of 
procedure. 
Article  6 
1. Where  recourse  is had  to the procedure  defined 
in this  Article,  the matter  shall  be placed  before  the 
Committee  by  its chairman,  either  on  his  own 
initiative  or at the request  of the representative  of a 
Member  State. 
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 
this draft  within  a period  to be  fixed  by  the 
chairman  according  to the urgency  of the matter.  Its 
Opinions  shall  be adopted  by a majority  of 41 votes, 
the votes  of the  Member  States  being  weighted  as 
provided  in Article  148  (2)  of the  Treaty.  The 
chairman  shall  not vote. 
3. (a) The  Commission  shall  adopt  the  proposed 
measures  if they  are  in accordance  with  the 
Opinion  of the Committee. 
(b) If the  proposed  measures  do not  obtain  the 
approval  of the Committee  or if no Opinion  is 
expressed,  the  Commission  shall  without 
delay  submit  to the Council  a proposal  on the 
measures  to be taken.  The  Council  shall  act 
by a qualified  majority. 
(c) If within  three  months  of the  date  on which 
the matter  was  brought  before  it the Council 
has not acted,  the proposed  measures  shall  be 
adopted  by the Commission. 
Article  7 
1. Where  a Member  State  establishes  that  an 
appliance  although  satisfying  the requirements  of the 
Directive,  constitutes  a hazard  to safety  or public 
health,  it may  provisionally  prohibit  the sale  of that 
appliance  in its territory.  It shall  immediately  inform 
the Commission  and  the  other  Member  States 
thereof,  and give  reasons  for its decision. 
12. 2. 75 Official  Journal  of the  European  Communities No C 33/7 
2. The  Commission  shall,  within  six  weeks, 
consult  the  Member  States  concerned.  It shall  then 
deliver  its Opinion  forthwith  and  take  appropriate 
measures. 
3. Where  the  Commission  is of the  opinion  that 
technical  adaptations  to the  Directive  are  necessary, 
such  adaptations  shall  be  adopted  by  either  the 
Commission  or the  Council  under  the  procedure  laid 
down  in Article  6. In this  event,  the  Member  State 
having  adopted  safeguard  measures  may  maintain 
them  until  such  adaptations  enter  into  force. 
Article  8 
Models  of the  marks  and  certificates  of conformity 
referred  to in Article  2 (1)  shall  be published  for 
information  in the  Official  Journal  of  the  European 
Communities. 
Article  9 
The Member  States  shall  take  all  appropriate 
measures  to ensure  that  marks  and  certificates  of conformity  are  issued  by  the  manufacturer  only 
under  the conditions  laid  down  in the Directive. 
Article  10 
1. Member  States  shall  adopt  and  publish  the 
provisions  necessary  to comply  with  the  requirements 
of this  Directive  by 31  December  1976  and  shall 
forthwith  inform  the Commission  thereof. 
They  shall  apply  these  provisions  with  effect  from 
1 July  1977. 
2. Once  notification  of this  Directive  has  been 
effected,  the  Member  States  shall  inform  the 
Commission,  in sufficient  time  to enable  it to submit 
its comments,  of  all  draft  laws,  regulations  or 
administrative  provision  which  they  intend  to adopt 
in the field  covered  by this  Directive. 
Article  11 
This  Directive  is adressed  to the Member  States. 
ANNEX 
The following  types  of equipment  are excluded  from  the scope  of this  Directive: 
1. Electro-radiological  equipment 
2. Diagnostics: 
Electrocardiographs/electrocardioscopes 
Patient  monitoring: 
— direct  and  indirect  blood  pressure  equipment 
— temperature  measuring  equipment 
— respiratory  measuring  equipment 
— cerebral  function  equipment 
— oxymetry  equipment 
— pulse  measuring  equipment 
Electroencephalographs/electrocartisographs 
Ultrasonic,  diagnostics  equipment 
Electromyography  equipment 
Tonometers 
No C 33/8 Official  Journal  of the  European  Communities 12. 2. 75 
3. Therapy: 
Shortwave/microwave/ultrasonic  therapy  equipment 
Defibrillators 
Pacemakers,  implantable  and  not  implantable 
Low  frequency  and  galvanic  stimulators 
Artificial  kidneys 
4. Surgery  and  anaesthesia: 
Surgery  equipment 
Endoscopy/electrocautery 
Anaesthesia  equipment 
Respiration  equipment 
Electromechanical  equipment  (saws,  drills) 
Laser  coagulators 
5. Miscellaneous: 
Electrotechnical  equipment  in dentistry 
Electric  sterilizers. 
II 
Proposal  for  a Council  Directive  on the  approximation  of the  laws  of Member  States 
relating  to medical  X-ray  equipment  operating  at 10 to 400  kV 
THE  COUNCIL  OF  THE  EUROPEAN 
COMMUNITIES, 
Having  regard  to  the  Treaty  establishing  the 
European  Economic  Community,  and  in particular 
Article  100  thereof; 
Having  regard  to the proposal  from  the Commission; 
Having  regard  to the  Opinion  of the  European 
Parliament; 
Having  regard  to the  Opinion  of the  Economic  and 
Social  Committee; 
Whereas,  in each  Member  State,  electro-radiological 
appliances  must  satisfy  a high  and  clearly-defined 
standard  of safety  both  for  the  users  of such 
equipment  and  for those  receiving  treatment  by means 
of the equipment; 
Whereas  several  Member  States  have  sought  to 
ensure  that  standard  of  safety  by  mandatory 
specifications  relating  both  to the  technical  safety 
regulations  and  the  inspection  procedures,  and 
whereas  those  specifications  vary  from  one  Member 
State  to another; Whereas  those  impediments  to the establishment  and 
operation  of the Common  Market  can  be reduced  or 
eliminated  if the  same  specifications  are adopted  by 
all the  Member  States,  either  in addition  to or in 
place  of their  present  legislation; 
Whereas  it is expedient  in the  first  instance  to 
harmonize  at Community  level  one  section  of 
electro-radiological  equipment;  whereas  the  most 
adequate  form  of harmonization  is by reference  to 
the standards  drawn  up  by  the  International 
Electrotechnical  Commission; 
Whereas,  for the protection  of patients  and  operators 
against  ionizing  radiation,  type-approval  of  the 
equipment  appears  to be necessary; 
Whereas,  in order  to ensure  that  the  equipment 
complies  with  the  specifications  of the  harmonized 
standards  other  than  those  relating  to protection 
against  ionizing  radiation,  the  manufacturer 
acknowledges  liability  by a mark  or certificate  of 
conformity, 
12. 2. 75 Official  Journal  of the  European  Communities No C 33/9 
HAS  ADOPTED  THIS  DIRECTIVE: 
Article  1 
1. This  Directive  shall  apply  to medical  X-ray 
equipment  operating  at 10 to 400  kV,  used  in the 
practice  of  human  or  veterinary  medicine, 
hereinafter  called  the 'equipment'. 
2. Medical  X-ray  equipment  is understood  to 
mean  electrical  equipment  which  uses  ionizing 
radiation  from  an electrical  or radioactive  source. 
Article  2 
1. Member  States  may  not  on grounds  of safety 
requirements  prohibit  the sale,  free  movement  or use 
of equipment  coming  within  Article  1 of this 
Directive: 
— if its conformity  with  the harmonized  standards  in 
regard  to radiological  safety  is attested  by an EEC 
type-approval  certificate  in accordance  with 
Article  5 and  the  EEC  type-approval  mark 
referred  to in Article  6; 
— if its conformity  with  the  specifications  of the 
harmonized  standards  other  than  those  relating  to 
protection,  from  ionizing  radiation  is attested  by 
the manufacturer  under  the conditions  laid  down 
in Article  2 (1) of the Council  Directive  of 
on the  approximation  of the  laws  of Member 
States  relating  to electromedical  equipment. 
2. For  the  purposes  of this  Directive,  the  term 
'harmonized  standards'  shall  be taken  to refer  to: 
— 'general  safety  requirements  for  electromedical 
equipment',  IEC  draft  recommendation  62A 
(Secretariat)  10 of 
— 'protection  against  radiation  from  X-ray 
equipment  operating  at 10  to 400  kV',  IEC 
recommendation  No  407,  first  edition,  March 
1973. 
Article  3 
Every  Member  State  shall  ensure  that  medical 
expenses  incurred  in connection  with  the  use  of 
equipment  complying  with  the  prescriptions  of this 
Directive  qualify  for  reimbursement  on  the  same 
terms  as expenses  incurred  in connection  with  the use 
of equipment  complying  with  the  requirements  in 
force  within  its territory. Article  4 
Any amendments  required  to adapt  the  harmonized 
standards  to technical  progress  shall  be adopted  in 
accordance  with  the procedure  laid  down  in Article  6 
of the  Council  Directive  of on  the  approxi-
mation  of the  laws  of Member  States  relating  to 
electromedical  equipment. 
Article  5 
1. The  authorized  bodies  in the  Member  States 
shall  approve  any  type  of equipment  provided  that  it 
is in conformity  with  the harmonized  standards  with 
respect  to radiological  safety. 
2. The  authorized  body  which  grants  EEC 
type-approval  shall  draw  up an inspection  report, 
which  shall  be available  to the Member  States. 
A copy  of the EEC  type-approval  certificate  shall  be 
forwarded  to the  authorized  bodies  in the  Member 
States  within  one  month  after  the  issue  of the 
certificate. 
3. The  authorized  body  which  issues  the  EEC 
type-approval  certificate  may  withdraw  approval  if it 
finds  that  the certificate  should  not  have  been  issued 
or that  the conditions  imposed  have  not been  fulfilled 
within  a reasonable  set period. 
It may  also  withdraw  approval  if the  manufacturer 
places  on the  market  equipment  which  does  not 
conform  with  the approved  prototype. 
4. Withdrawal  of type-approval  and  the  reasons 
for withdrawal  shall  be notified  within  one  month  to 
the other  Member  States  and  the manufacturer. 
5. The  application  for  EEC  type-approval  with 
respect  to a particular  type  of equipment  may  not be 
submitted  to more  than  one  Member  State. 
Article  6 
The mark  of EEC  type-approval,  affixed  to the 
equipment  by  the  manufacturer,  attests  that  the 
equipment  is in conformity  with  the type  which  has 
been  granted  the certificate  of EEC  type-approval. 
Article  7 
Member  States  shall  take  all appropriate  measures  to 
ensure  that  marks  are  affixed  by the  manufacturer 
only under  the conditions  laid  down  in the Directive. 
No C 33/10 Official  Journal  of the  European  Communities 12. 2. 75 
Article  8 
1. Where  a Member  State  establishes  that 
an appliance  although  satisfying  the requirements  of 
the Directive,  constitutes  a hazard  to safety  or public 
health,  it may  provisionally  prohibit  the  sale  of that 
appliance  in its territory.  It shall  immediately  inform 
the Commission  and  the  other  Member  States 
thereof,  and  give  reasons  for its decision. 
2. The  Commission  shall,  within  six  weeks, 
consult  the  Member  States  concerned.  It shall  then 
deliver  its Opinion  forthwith  and  take  appropriate 
measures. 
3. Where  the  Commission  is of the  opinion  that 
technical  adaptation  to the  Directive  are  necessary, 
such  adaptations  shall  be adopted  by  either  the 
Commission  or the Council  under  the procedure  laid 
down  in Article  6 of the  Council  Directive  of 
on the  approximation  of the  laws  of the  Member 
States  relating  to electromedical  equipment.  In this 
event,  the  Member  State  having  adopted  safeguard 
measures  may  maintain  jhem  until  such  adaptations 
enter  into  force. 
Article  9 
Models  of the  inspection  reports  shall  be drawn  up 
by agreement  between  the  authorized  bodies,  whose 
names  have  been  notified  in accordance  with  Article 
10. The models  of the  EEC  type-approval  marks  and 
certificates  are given  in the Annex. 
Article  10 
Each  Member  State  shall  forward  to the  other 
Member  States  and  the  Commission  a list  of the 
bodies  referred  to in Article  5, who  are authorized  to 
grant  EEC  type-approval  in respect  of the equipment. 
It shall  also  give  notice  of any  amendment  to the list. 
Article  11 
1. Member  States  shall  adopt  and  publish  the 
provisions  necessary  to comply  with  the.  requirements 
of this  Directive  by 31 December  1976  and  shall 
forthwith  inform  the Commission  thereof. 
They  shall  apply  these  provisions  with  effect  from 
1 July  1977. 
2. Once  notification  of this  Directive  has  been 
effected,  the  Member  States  shall  inform  the 
Commission,  in sufficient  time  to enable  it to submit 
its comments,  of all  draft  laws,  regulations  or 
administrative  provision  which  they  intend  to adopt 
in the field  covered  by this  Directive. 
Article  12 
This  Directive  is addressed  to the Member  States. 
12. 2. 75 Official  Journal  of the  European  Communities 
k ; No C 33/11 
ANNEX 
CERTIFICATE  OF  EEC  TYPE-APPROVAL 
Authorized  body: 
Application  of Council  Directive  No of 
EEC  type-approval  Code  No 
Type  of electromedical  equipment 
Date: 
Manufacturer's  name  and  address: 
The undersigned  hereby  declares  that  he has verified  that  the test  prescribed  in the harmonized 
standards  for Article  2 (1) of the Directive  was  carried  out successfully. 
General  remarks: 
Done  and  certified  this  day  of at 
(signature  and  capacity) 
MARK  OF  EEC  TYPE-APPROVAL 
The mark  of approval  as provided  for in Article  9 of this  Directive  is in the form  of a hexagon 
with  stylized  letter  £ with: 
— in the top part,  the distinctive  capital  letter  of the State  which  has  granted  approval  (B  for 
Belgium,  D for Federal  Republic  of Germany,  DK  for Denmark,  F for France,  I for Italy, 
IR for Ireland,  L for Luxemburg,  NL  for  the Netherlands,  UK  for United  Kingdom)  and 
the date  and  year  of approval; 
— in the bottom  part  the distinctive  symbol  of the authorized  body  which  issued  the approval 
followed  by distinctive  EEC  type-approval  number. 
The approval  mark  which  is affixed  by the manufacturer  in accordance  with  the provisions  of 
this Directive,  must  be easily  visible,  legible,  irremovable,  and  indestructible. 
Mark  of EEC  type-approval 
EEC  type-approval  issued  by the competent  authority  of the 
Federal  Republic  of Germany  in 1974; 
distinctive  No of EEC  type-approval. Example: 
The diameter  of the circle  surrounding  the marks  shall  be at least  10 mm.