Proposal for a Directive of the European Parliament and of the Council repealing Council Directive 84/539/EEC on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine
Date: 2007-08-07
Institutions: European Commission
Subjects: EC Directive, approximation of laws, electrical equipment, quality label, repeal, technical regulations, veterinary medicine

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 7.8.2007 
COM(2007) 465 final 

2007/0168 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

repealing Council Directive 84/539/EEC on the approximation of the laws of the 
Member States relating to electro-medical equipment used in veterinary medicine 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

On 16 March 2005 the Commission adopted a key Communication on Better Regulation for 
Growth  and  Jobs  in  the  European  Union  (COM  (2005)  97  final)  which  stressed  the 
importance of simplification of national and European legislation. Better Regulation is crucial 
for improving the competitiveness of European enterprises and for achieving the objectives of 
the Lisbon Agenda. Indeed, improving the quality of the regulatory framework helps cutting 
unnecessary costs and removing obstacles that hinder adaptation and innovation; it creates the 
right incentives for business and market framework conditions which allow business to thrive, 
so that it can create the wealth our economies need. 

As  stated  in  the  Commission  Communication  on  Implementing  the  Community  Lisbon 
Programme: a strategy for the simplification of the regulatory environment (COM (2005) 535 
final), the review of the “acquis” must become a continuous and systematic process, enabling 
the  legislator  to  revise  legislation  by  taking  all  legitimate  private  sector  and  public  interests 
into  account.  The  Communication  sets  out  a  rolling  programme  which  forms  part  of  a  new 
strategy  for  simplification.  This  programme  specifies  those  pieces  of  legislation  that  the 
Commission envisages reviewing and assessing, with the view to simplifying them.  

In  2006  the  Commission  adopted  its  Commission  Working  Document,  First  progress  report 
on the strategy for the simplification of the regulatory environment (COM(2006) 690 final). 
In view of the importance of the continuous re-examination of the acquis, the Commission has 
identified a further 43 additional initiatives with a potential simplification dimension for the 
period 2006-2009. Included in this re-examination is Council Directive 84/539/EEC, adopted 
on  17  September  1984,  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
electro-medical equipment used in veterinary medicine.  

Having  reviewed  the  implementation  and  application  of  this  Directive,  the  Commission  has 
concluded to propose its repeal. 

2. 

RESULTS OF CONSULTATIONS WITH INTERESTED PARTIES AND ASSESSMENT  

2.1. 

Consultations 

The  starting  point  for  reviewing  whether  it  would  be  useful  to  keep  Directive  84/539/EEC, 
adopted  on  17  September  1984  on  the  approximation  of  the  laws  of  the  Member  States 
relating to electro-medical equipment used in veterinary medicine, as part of the “acquis” or 
not, was the opinions expressed by Member States and industries that, over a number of years, 
the Directive had not been generally applied in the trade of these devices.  

As part of the Commission preparatory work, and in accordance with the principles of Better 
Regulation, Member States and stakeholders were consulted. 

A meeting was held with the Member States to establish whether the Directive was applied or 
not and to collect their views on a possible repeal of the Directive. The industry associations 
were  also  consulted  on  an  individual  basis.  Both  enquiries  lead  to  the  same  conclusion:  the 
Directive does not serve its purpose anymore. 

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2.2. 

Enquiry results and assessment 

The main reasons mentioned for not applying the Directive 84/539/EEC were the following: 

1. 

The application of Directive 84/539/EEC has been limited over the past years, since 
most manufacturers use Directive 93/42/EEC on medical devices (for human use) as 
their starting point.1

Most  electrical  medical  devices  manufacturers  placed  their  products  on  the 
Community  market  for  ‘dual  use’  meaning  that  they  can  be  used  both  for  human 
beings  and  animals.  The  rational  behind  the  approach  of  manufacturers  to  aim  for 
‘dual  use’  is  that  the  market  for  electro-medical  equipment  used  in  veterinary 
medicine  is  very  small.  In  addition,  it  appears  that  the  Community  regulatory 
framework for medical devices for human use is suitable for ensuring the quality and 
safety of electro-medical equipment for veterinary use. 

Article  2  of  Directive  84/539/EEC  is  applied  in  cases  of  ‘dual  use’.  This  provision 
determines  that  where  a  medical  device  conforms  to  the  requirements  of  Directive 
93/42/EEC on medical devices (for human use) it is deemed to be in conformity with 
Directive 84/539/EEC. 

Even  in  the  case  of  specific  products  only  used  in  veterinary  medicine,  the 
application  of  the  current  Community  legislation  in  force  is  considered  a  better 
option offering the appropriate guarantees for health and safety aspects in this very 
small market. The general Community regulatory framework that provides adequate 
rules are: 

– 

– 

– 

Directive 2006/42/EC on machinery2 

Directive 2004/108/EC relating to electromagnetic compatibility3 

Directive 85/374/EEC on product liability4 

The  methods  of  conformity  by  means  of  the  (compulsory)  application  of  standard 
HD 395-I: General Requirements (1979 edition – document based on IEC No 601-
1of  the  International  Electrotechnical  Commission)  is  no  longer  appropriate  nor  in 
force. The standard is statically referred to in Annex I of Directive 84/539/EEC. This 
standard  has  been  revised  during  the  past  years,  and  is  currently  listed  as  a 
harmonised standard under Directive 93/42/EEC on medical device.5

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169/1, 12.7.1993, as 
last amended by Regulation (EC) No 1882/2003, OJ L 284/1, 31.10.2003. 
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, 
and amending Directive 95/16/EC (recast), OJ L 157/24, 9.6.2006. 
Directive  2004/108/EC  of  the  European  Parliament  and  of  the  Council  of  15  December  2004  on  the 
approximation of the laws of the Member Sates relating to electromagnetic compatibility and repealing 
Directive 89/336/EEC, OJ L 390/24, 31.12.2004. 
Council  Directive  85/374/EEC  of  25  July  1985  on  the  approximation  of  the  laws,  regulations  and 
administrative  provisions  of  the  Member  States  concerning  liability  for  defective  products,  OJ  L 
210/29, 7.8.1985, as last amended by Directive 1999/34/EC of 10 May 1999, OJ L 141/20, 4.6.1999. 
EN  60601-1:1990  medical  electrical  equipment,  Part  1:  General  requirements  for  basic  safety  and 
essential performance. 

2. 

3. 

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4. 

Directive  84/539/EEC  on  the  approximation  of  the  laws  of  the  Member  States 
relating to electro-medical equipment used in veterinary medicine was adopted as a 
measure to develop the internal market for these devices. 

The internal market for these devices is seemingly without any hindrances due to the 
fact  that  other  relevant  Community  legislation  can  be  applied.  It  appears  that  the 
Directive  84/539/EEC  is  not  necessary  for  the  internal  market  trade  or  trade  with 
third countries and no obstacles to trade have been noted in the sector concerned. 

In  light  of  the  above,  repealing  of  Directive  84/539/EEC  is  necessary  to  simplify  the 
regulatory environment, by suppressing a non-essential legal instrument having a very limited 
application and which is not necessary for internal market reasons or for ensuring the health 
and safety aspects relating to these devices. 

Therefore,  it  was  decided  not  to  replace  the  Directive  by  other  legislative  measures  or  to 
modify it. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Subsidiarity and proportionality principles 

Following the results of the consultation and the assessment, it is evident that the objectives of 
Directive 84/539/EEC can be adequately achieved by other relevant Community legislation. 

3.2. 

Choice of instrument: the form of the act  

When an act is repealed the principle of “parallel forms” applies; that is to say, the repeal of 
Directive 84/539/EEC would be effected by a repealing Directive.  

3.3. 

Budgetary implications 

The proposal does not have any budgetary implications 

4. 

CONCLUSION 

The proposal to repeal Directive 84/539/EEC on the approximation of the laws of the Member 
States  relating  to  electro-medical  equipment  used  in  veterinary  medicine  is  in  line  with  the 
results of the consultations with Member States and industry. 

It is however important that the repeal of Directive 84/539/EEC be followed by the repeal of 
the  corresponding  national  implementing  measures,  in  order  to  have  the  desired  practical 
effect. The specimen mark of conformity of Annex III will no longer be available for use. 

In addition, it should be ensured that the advantages of the repeal are not cancelled out by new 
national rules or new technical barriers. Accordingly, it is important to note that any national 
rules  on  electro-medical  equipment  used  in  veterinary  medicine  are  consistent  with  the 
principles  of  Article  28  of  the  EC-Treaty  and  do  not  constitute  unjustified  barriers  to  trade, 
and  with  the  above  mentioned  applicable  Community  legislation.  Moreover,  any  national 

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measures which might be considered to be technical regulations for the purpose of Directive 
98/34/EC6 must be notified to the Commission in draft form. 

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Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998  laying  down  a 
procedure  for  the  provision  of  information  in  the  field  of  technical  standards  and  regulations  and  of 
rules on Information Society services, OJ L 204/37, 21.7.1998, as last amended by Council Directive 
2006/96/EC, OJ L 363/81, 20.12.2006. 

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2007/0168 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

repealing Council Directive 84/539/EEC on the approximation of the laws of the 
Member States relating to electro-medical equipment used in veterinary medicine 

(text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission7, 
Having regard to the opinion of the European Economic and Social Committee8, 
Having regard to the opinion of the Committee of the Regions9, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty10, 

Whereas: 

(1) 

(2) 

Community  policies  on  better  regulation  stress  the  importance  of  simplification  of 
national  and  Community  legislation  as  a  crucial  element  for  improving  the 
competitiveness of enterprises and for achieving the objectives of the Lisbon Agenda.  

The method of conformity assessment provided by 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 veterinary medicine11 is no longer necessary for the 
purposes of the internal market and trade with third countries. 

(3) 

The functioning of the internal market and the protection of users and animals can be 
better ensured by other Community legislation. 

(4) 

Directive 84/539/EEC should therefore be repealed. 

(5) 

The repeal of Council Directive 84/539/EEC entails that after 31 December 2008 the 
specimen  mark  of  conformity  of  Annex  III  will  no  longer  be  used  and  that  the 
corresponding national implementing measures have to be repealed accordingly, 

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OJ C , , p. . 
OJ C , , p.  
OJ C , , p.  
OJ C , , p.  
OJ L 300/179, 19.11.1984, as last amended by Regulation (EC) No 807/2003, OJ L 122/36 16.5.2003. 

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HAVE ADOPTED THIS DIRECTIVE: 

Directive 84/539/EEC is repealed with effect from 31 December 2008. 

Article 1 

Article 2 

1. 

Member States shall adopt and publish, by 31 December 2008 at the latest, the laws, 
regulations  and  administrative  provisions  necessary  to  comply  with  this  Directive. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions 
and a correlation table between those provisions and this Directive. 

They shall apply those provisions from 1 January 2009. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

Article 3 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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