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To harmonise the design and construction of machinery with a view to protecting the safety of persons using such machinery and ensuring its free movement in the internal market.

2) ACT

European Parliament and Council Directive 98/37/EC of 22 June 1998 on the approximation of the laws of the Member States relating to machinery [Official Journal L 207 of 23.07.1998].

Amended by European Parliament and Council Directive 98/79/EC of 27 October 1998 [Official Journal L 331 of 07.12.1998].


Directive 98/37/EC

The current Directive covers machinery and individually marketed safety components of such machinery. They replace and codify (regroup) Directives 89/392/EEC and 93/44/EEC on the approximation of the laws of the Member States relating to machinery as amended by Directives 91/368/EEC and 93/68/EEC.

Some machines are not covered by the scope of the Directive.

They define the objectives or "essential requirements" of safety and health which must be met by machinery and safety components during manufacture and before being marketed.

Harmonized European standards are drawn up on the basis of the essential requirements by European Standards Bodies. These standards, which are not obligatory, are published in the Official Journal of the European Union and transposed in the form of national standards with identical contents.

Any machine or safety component manufactured in accordance with the harmonised standards is deemed to conform to the essential requirements.

Conformity of machinery and safety components to the essential requirements is established by procedures described in the Directives.

Member States may not ban, restrict or obstruct the marketing and use on their territory of machinery and safety components which comply with these Directives.

Before being marketed machines must have an "CE" declaration of conformity and the CE mark of conformity which:

  • certifies their conformity to the Directives;
  • consists of a single "CE" symbol.

Before being marketed safety components must have an "CE" declaration of conformity.

Directive 98/79/EC

" Medical devices " are not covered by Directive 98/37/EC and therefore remain governed by the provisions of Directive concerning in vitro diagnostic medical devices.

The date for implementing this Directive is 07.06.2000.

of entry into force
Final date for implementation in the Member States
Directive 98/37/EC12.08.1998-
Directive 98/79/EC07.12.199807.12.1999


Notified bodies

The NANDO-IS database will enable you to find the European notified bodies as well as third country bodies which are responsible for carrying out the conformity assessment procedures referred to in the New Approach directives.

Publication of the titles and references of harmonised standards in accordance with the essential requirements of Directive 98/37/EC:

Official Journal C 95 of 20.04.2004
This list replaces lists previously published in the Official Journal.

List of titles and references of harmonised standards.


Proposal for a Directive of the European Parliament and of the Council of 26 January 2001 on machinery and amendingDirective 95/16/EC[COM (2000) 899 final - not published in the Official Journal]

This proposal has been based on the report of a group of independent experts (the Molitor group) who in 1995 were asked to assess the impact of Community and national legislation on competitiveness and employment. It aims to improve the various concepts referred to in the Directive (e.g. the concept of a "machine" is extended to include portable cartridge-operated devices, devices to lift persons with reduced mobility and construction site hoists) and clarifies procedures for conformity assessment and market surveillance.

Codecision procedure (COD/2001/0004):

Last updated: 30.04.2004

See also

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