CELEX: 51974PC2178(01)
Language: en
Date: 1974-12-20
Title: PROPOSAL FOR COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ELECTROMEDICAL EQUIPMENT

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                                    regulations and the inspection procedures, and
COMMUNITIES,                                                   whereas those specifications vary from one Member
                                                               State to another,
Having regard to the Treaty establishing the
European Economic Community, and in particular                 Whereas those impediments to the establishment and
Article 100 thereof;                                           operation of the common market can be reduced or
                                                               eliminated if the same specifications are adopted by
Having regard to the proposal from the Commission;             all the Member States, either in addition to or in
                                                               place of their present legislation,
Having regard to the Opinion of the European
Parliament;                                                    Whereas it is expedient in the first instance to
                                                               harmonize at Community level one section of
Having regard to the Opinion of the Economic and               electromedical equipment;         whereas the most
Social Committee;                                              adequate form of harmonization is by reference to
                                                               the standards drawn up by the International
                                                               Electrotechnical Commission;
Whereas, in each Member State, electromedical
appliances must satisfy a high and clearly-defined
standard of safety both for the users of such                  Whereas, in order to ensure that the equipment
equipment and for those receiving treatment by                 complies with the harmonized standards, the
means of the equipment;                                        manufacturer acknowledges his responsibility by a
                                                               mark or declaration of conformity;
Whereas several Member States have sought to
ensure that standard of safety by mandatory                    Whereas technological progress requires prompt
specifications relating both to the technical safety           adaptation of the technical specifications laid down
 ---pagebreak---  No C 33/6                         Official Journal of the European Communities                               12. 2. 75
  by the Directives with respect to electromedical                                     Article 5
  equipment; whereas, in order to facilitate the
  implementation of the measures required, provision          1.     A Committee on the Adaptation to Technical
 must be made for a procedure establishing close              Progress of the Directives on the Removal of
 cooperation between the Member States and the                Technical Barriers to Trade in Electromedical
 Commission within the Committee on the Adaptation            Equipment (hereinafter called 'the Committee'), is
 to Technical Progress of the Directives on the               hereby set up; it shall consist of representatives of the
 Removal of Technical Barriers to Trade in                    Member States, with a representative of the
 Electromedical Equipment;                                     Commission as chairman.
 Whereas it could happen that electrical equipment
 used in medicine although conforming to the                  2.     The Committee shall adopt its own rules of
 provisions of this Directive and its Annexes, endanger       procedure.
 public health; whereas it is, therefore, advisable to
 provide a procedure intended to remove this danger,
                                                                                       Article 6
HAS ADOPTED THIS DIRECTIVE:
                                                              1.     Where recourse is had to the procedure defined
                                                              in this Article, the matter shall be placed before the
                         Article 1
                                                              Committee by its chairman, either on his own
                                                              initiative or at the request of the representative of a
 This Directive shall apply to electromedical                 Member State.
 equipment (hereinafter called 'equipment') used in
 human or veterinary medicine, with the exception of
 the equipment listed in the Annex.                          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
                         Article 2                            this draft within a period to be fixed by the
                                                             chairman according to the urgency of the matter. Its
 1.    Member States may not on grounds of safety            Opinions shall be adopted by a majority of 41 votes,
 requirements prohibit the sale, free movement or use        the votes of the Member States being weighted as
 of equipment coming within Article 1 of this                provided in Article 148 (2) of the Treaty. The
Directive if its conformity with the harmonized               chairman shall not vote.
standards is attested by a mark of conformity affixed
to it or by a declaration of conformity issued by the        3. (a) The Commission shall adopt the proposed
manufacturer.                                                          measures if they are in accordance with the
                                                                       Opinion of the Committee.
2.    For the purposes of this Directive, the term
'harmonized standards' shall be taken to refer to the             (b) If the proposed measures do not obtain the
requirements set out in the 'recommendations for                       approval of the Committee or if no Opinion is
general safety requirements for electrical equipment                   expressed, the Commission shall without
used in medical practice' IEC draft recommendations                    delay submit to the Council a proposal on the
62A (Secretariat) 10 of                                                measures to be taken. The Council shall act
                                                                       by a qualified majority.
                         Article 3                                (c) If within three months of the date on which
                                                                       the matter was brought before it the Council
Every Member State shall ensure that medical                           has not acted, the proposed measures shall be
expenses incurred in connection with the use of                        adopted by the Commission.
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                                        Article 7
force within its territory.
                                                             1.      Where a Member State establishes that an
                                                             appliance although satisfying the requirements of the
                         Article 4                          Directive, constitutes a hazard to safety or public
                                                            health, it may provisionally prohibit the sale of that
Any amendments required to adapt the harmonized             appliance in its territory. It shall immediately inform
standards to technical progress shall be adopted in         the Commission and the other Member States
accordance with the procedure laid down in Article 6.       thereof, and give reasons for its decision.
 ---pagebreak--- 12. 2. 75                                    Official Journal of the European Communities                                            N o C 33/7
2.        T h e Commission shall, within six weeks,                              conformity are issued by the m a n u f a c t u r e r      only
consult the M e m b e r States concerned. It shall then                          u n d e r the conditions laid d o w n in the Directive.
deliver its O p i n i o n f o r t h w i t h a n d take a p p r o p r i a t e
measures.
                                                                                                              Article 10
3.        W h e r e the Commission is of the opinion that
technical a d a p t a t i o n s to the Directive are necessary,
                                                                                 1.        M e m b e r States shall a d o p t a n d publish the
such a d a p t a t i o n s shall be a d o p t e d by either the
                                                                                 provisions necessary to comply with the requirements
Commission or the Council under the procedure laid
                                                                                 of this Directive by 31 December 1976 a n d shall
d o w n in Article 6. In this event, the M e m b e r State
                                                                                 f o r t h w i t h inform the Commission thereof.
having a d o p t e d safeguard measures may maintain
them until such a d a p t a t i o n s enter into force.
                                                                                 T h e y shall apply these provisions with effect f r o m
                                                                                 1 July 1977.
                                  Article 8
                                                                                 2.        Once notification of this Directive has been
                                                                                 effected, the M e m b e r States shall inform the
M o d e l s of the m a r k s a n d certificates of conformity
                                                                                 Commission, in sufficient time t o enable it to submit
referred to in Article 2 (1) shall be published for
                                                                                 its comments, of all d r a f t laws, regulations or
i n f o r m a t i o n in the Official Journal of the European
                                                                                 administrative provision which they intend to a d o p t
Communities.
                                                                                 in the field covered by this Directive.
                                  Article 9
                                                                                                              Article 11
T h e M e m b e r States shall take all a p p r o p r i a t e
measures to ensure that m a r k s a n d certificates of                          This Directive is adressed to the M e m b e r 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
 ---pagebreak---  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                                      Whereas those impediments to the establishment and
COMMUNITIES,                                                     operation of the Common Market can be reduced or
                                                                 eliminated if the same specifications are adopted by
Having regard to the Treaty establishing the                     all the Member States, either in addition to or in
European Economic Community, and in particular                   place of their present legislation;
Article 100 thereof;
Having regard to the proposal from the Commission;
                                                                 Whereas it is expedient in the first instance to
                                                                 harmonize at Community level one section of
Having regard to the Opinion of the European
                                                                 electro-radiological equipment; whereas the most
Parliament;
                                                                 adequate form of harmonization is by reference to
                                                                 the standards drawn up by the International
Having regard to the Opinion of the Economic and
                                                                 Electrotechnical Commission;
Social Committee;
Whereas, in each Member State, electro-radiological
appliances must satisfy a high and clearly-defined               Whereas, for the protection of patients and operators
standard of safety both for the users of such                    against ionizing radiation, type-approval of the
equipment and for those receiving treatment by means             equipment appears to be necessary;
of the equipment;
Whereas several Member States have sought to                     Whereas, in order to ensure that the equipment
ensure that standard of safety by mandatory                      complies with the specifications of the harmonized
specifications relating both to the technical safety             standards other than those relating to protection
regulations and the inspection procedures, and                   against    ionizing    radiation,   the manufacturer
whereas those specifications vary from one Member                acknowledges liability by a mark or certificate of
State to another;                                                conformity,
 ---pagebreak--- 12. 2. 75                             Official Journal of the European Communities                          No C 33/9
HAS ADOPTED THIS DIRECTIVE:                                                             Article 4
                                                                Any amendments required to adapt the harmonized
                         Article   1                            standards to technical progress shall be adopted in
                                                                accordance with the procedure laid down in Article 6
1.    This Directive shall apply to medical X-ray               of the Council Directive of            on the approxi-
equipment operating at 10 to 400 kV, used in the                mation of the laws of Member States relating to
practice of      human       or veterinary        medicine,     electromedical equipment.
hereinafter called the 'equipment'.
2.    Medical X-ray equipment is understood to                                          Article 5
mean electrical equipment which uses ionizing
radiation from an electrical or radioactive source.             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
                         Article 2                              respect to radiological safety.
                                                                2.    The authorized body which grants EEC
1.    Member States may not on grounds of safety
                                                                type-approval shall draw up an inspection report,
requirements prohibit the sale, free movement or use
                                                                which shall be available to the Member States.
of equipment coming within Article 1 of this
Directive:                                                      A copy of the EEC type-approval certificate shall be
                                                                forwarded to the authorized bodies in the Member
— if its conformity with the harmonized standards in            States within one month after the issue of the
    regard to radiological safety is attested by an EEC         certificate.
    type-approval certificate in accordance with
    Article 5 and the EEC type-approval mark
                                                                3.    The authorized body which issues the EEC
    referred to in Article 6;
                                                                type-approval certificate may withdraw approval if it
                                                                finds that the certificate should not have been issued
— if its conformity with the specifications of the
                                                                or that the conditions imposed have not been fulfilled
    harmonized standards other than those relating to
                                                                within a reasonable set period.
    protection, from ionizing radiation is attested by
    the manufacturer under the conditions laid down             It may also withdraw approval if the manufacturer
    in Article 2 (1) of the Council Directive of                places on the market equipment which does not
    on the approximation of the laws of Member                  conform with the approved prototype.
    States relating to electromedical equipment.
                                                                4.    Withdrawal of type-approval and the reasons
2.    For the purposes of this Directive, the term              for withdrawal shall be notified within one month to
'harmonized standards' shall be taken to refer to:              the other Member States and the manufacturer.
— 'general safety requirements for electromedical
    equipment', IEC draft recommendation 62A                    5.    The application for EEC type-approval with
    (Secretariat) 10 of                                          respect to a particular type of equipment may not be
                                                                submitted to more than one Member State.
— 'protection      against       radiation    from X-ray
    equipment operating at 10 to 400 kV', IEC
    recommendation No 407, first edition, March                                          Article 6
    1973.
                                                                 The mark of EEC type-approval, affixed to the
                                                                equipment by the manufacturer, attests that the
                         Article 3                               equipment is in conformity with the type which has
                                                                 been granted the certificate of EEC type-approval.
Every Member State shall ensure that medical
expenses incurred in connection with the use of
equipment complying with the prescriptions of this                                       Article 7
Directive qualify for reimbursement on the same
terms as expenses incurred in connection with the use            Member States shall take all appropriate measures to
of equipment complying with the requirements in                 ensure that marks are affixed by the manufacturer
force within its territory.                                      only under the conditions laid down in the Directive.
 ---pagebreak--- N o C 33/10                        Official Journal of the European Communities                             12. 2. 75
                        Article 8                            The models of the EEC type-approval marks and
                                                             certificates are given in the Annex.
1.    Where a Member State establishes that
an appliance although satisfying the requirements of
the Directive, constitutes a hazard to safety or public                               Article 10
health, it may provisionally prohibit the sale of that
appliance in its territory. It shall immediately inform       Each Member State shall forward to the other
the Commission and the other Member States                    Member States and the Commission a list of the
thereof, and give reasons for its decision.                   bodies referred to in Article 5, who are authorized to
                                                              grant EEC type-approval in respect of the equipment.
2.    The Commission shall, within six weeks,                 It shall also give notice of any amendment to the list.
consult the Member States concerned. It shall then
deliver its Opinion forthwith and take appropriate
                                                                                      Article 11
 measures.
                                                              1.    Member States shall adopt and publish the
 3.    Where the Commission is of the opinion that
                                                              provisions necessary to comply with the. requirements
 technical adaptation to the Directive are necessary,         of this Directive by 31 December 1976 and shall
 such adaptations shall be adopted by either the              forthwith inform the Commission thereof.
 Commission or the Council under the procedure laid
 down in Article 6 of the Council Directive of                They shall apply these provisions with effect from
 on the approximation of the laws of the Member               1 July 1977.
 States relating to electromedical equipment. In this
 event, the Member State having adopted safeguard             2.    Once notification of this Directive has been
 measures may maintain jhem until such adaptations            effected, the Member States shall inform the
 enter into force.                                            Commission, in sufficient time to enable it to submit
                                                              its comments, of all draft laws, regulations or
                                                              administrative provision which they intend to adopt
                         Article 9                            in the field covered by this Directive.
  Models of the inspection reports shall be drawn up
  by agreement between the authorized bodies, whose                                    Article 12
  names have been notified in accordance with Article
  10.                                                         This Directive is addressed to the Member States.
 ---pagebreak--- 12. 2. 75                        Official Journal of the European Communities                              N o C 33/11
                                                               k                  ;
                                                          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
          Example:                            EEC type-approval issued by the competent authority of the
                                              Federal Republic of Germany in 1974;
                                              distinctive No of EEC type-approval.
          The diameter of the circle surrounding the marks shall be at least 10 mm.