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EU–Switzerland mutual recognition agreement (MRA)

 

SUMMARY OF:

Agreement between the European Community and Switzerland on mutual recognition in relation to conformity assessment

Decision 2002/309/EC, Euratom on the conclusion of seven Agreements with Switzerland

WHAT IS THE AIM OF THE AGREEMENT AND OF THE DECISION?

The mutual recognition agreement (MRA)* aims to promote trade in goods between the European Community (now the EU) and Switzerland by removing technical barriers. Under the bilateral agreement that EU countries approved on 21 June 1999, the EU and Switzerland accept the conformity assessment* results each carries out for specified industrial products. It is a comprehensive agreement based on the equivalence of Switzerland’s legislation to that of EU. It covers the recognition of conformity assessments irrespective of the origin of the products, except for Chapter 15 on Medicinal products, GMP Inspection and Batch Certification. This type of MRA agreement is usually referred to as an ‘Enhanced MRA’. However, the case of Switzerland remains quite unique.

The decision adopts the mutual recognition agreement as part of a package of 7 agreements with Switzerland.

KEY POINTS

The agreement covers the following product sectors:

  • machinery
  • personal protective equipment
  • toys
  • medical devices
  • gas appliances and boilers
  • pressure vessels
  • radio equipment and telecommunications terminal equipment
  • equipment and protective systems intended for use in potentially explosive atmosphere
  • electrical equipment and electromagnetic compatibility
  • construction plant and equipment
  • measuring instruments and prepackages
  • motor vehicles
  • agricultural or forestry tractors
  • good laboratory practice (GLP)
  • medicinal products, GMP inspection and batch certification
  • construction products
  • lifts
  • biocidal products
  • cableway installations
  • explosives for civil use.

Main features of the agreement:

  • mutual acceptance by the EU and Switzerland of reports, certificates, authorisations and conformity marks issued by recognised conformity assessment bodies*;
  • mutual recognition of manufacturers’ declarations certifying that products covered by the agreement conform to the other party’s requirements, as well as EU legislation;
  • the 2 parties ensure that the designating authorities* have the necessary power and competence to designate conformity assessment bodies or withdraw designation, suspend, or liftsuspension of designated conformity assessment bodies;
  • the parties share information on the procedures used to ensure conformity assessment bodies comply with the agreement's general designation principles;
  • in exceptional circumstances, parties have the right to contest the technical competence of the conformity assessment bodies of the other party;
  • parties will share information on implementation and application of the legislative, regulatory and administrative rules;
  • in order to obtain the information necessary to perform the necessary product checks, the competent authority of a party may also:
    • approach the competent authority of the other party;
    • enter into direct contact with the manufacturer; or
    • if appropriate, enter into direct contact with the manufacturer’s agent in the territory of the other party.

This agreement entered into force only following ratification of all the following 7 agreements between the EU and Switzerland:

FROM WHEN DOES THE AGREEMENT APPLY?

The agreement entered into force on 1 June 2002.

BACKGROUND

In their resolution of 21 December 1989, EU governments agreed the principles of MRAs. On 21 September 1992, they authorised the European Commission to negotiate mutual recognition agreements on behalf of the EU with certain non-EU countries.

For more information, see:

KEY TERMS

Mutual recognition agreement: an international agreement where 2 or more countries recognise each other’s conformity assessment results.
Conformity assessment: the procedure in which a product, before it can be marketed, is tested, inspected and certified to ensure it complies with the relevant legislation.
Conformity assessment bodies: these assess whether a product meets the relevant regulatory or legislative requirements.
Designating authority: a national authority with the legal power to designate, suspend, withdraw designation, or lift suspension of conformity assessment bodies.

MAIN DOCUMENTS

Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ L 114, 30.4.2002, pp. 369-429)

Successive amendments to the Agreement have been incorporated in the original text. This consolidated version is of documentary value only.

Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation (OJ L 114, 30.4.2002, pp. 1-5)

RELATED DOCUMENTS

Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other, on the free movement of persons — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ L 353, 31.12.2009, pp. 71-90)

See consolidated version.

Agreement between the European Community and the Swiss Confederation on Air Transport — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ L 114, 30.4.2002, pp. 73-90)

See consolidated version.

Agreement between the European Community and the Swiss Confederation on the Carriage of Goods and Passengers by Rail and Road — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ L 114, 30.4.2002, pp. 91-131)

See consolidated version.

Agreement between the European Community and the Swiss Confederation on trade in agricultural products — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ L 114, 30.4.2002, pp. 132-368)

See consolidated version.

Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ L 114, 30.4.2002, pp. 369-429)

See consolidated version.

Agreement between the European Community and the Swiss Confederation on certain aspects of government procurement — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ L 114, 30.4.2002, pp. 430-467)

See consolidated version.

Uruguay Round of Multilateral Trade Negotiations (1986-1994) — Annex 1 — Annex 1A — Agreement on Technical Barriers to Trade (WTO-GATT 1994) (OJ L 336, 23.12.1994, pp. 86-99)

Agreement on the European Economic Area — Final Act — Joint Declarations — Declarations by the Governments of the Member States of the Community and the EFTA States — Arrangements — Agreed Minutes — Declarations by one or several of the Contracting Parties of the Agreement on the European Economic Area (OJ L 1, 3.1.1994, pp. 3-522)

See consolidated version.

Council Resolution of 21 December 1989 on a global approach to conformity assessment (OJ C 10, 16.1.1990, pp. 1-2)

Agreement between the European Economic Community and the Swiss Confederation — Protocol No 1 concerning the treatment applicable to certain products — Protocol No 2 concerning products subject to special arrangements to take account of differences in the cost of agricultural products incorporated therein — Protocol No 3 concerning the definition of the concept of ‘originating products’ and methods of administrative cooperation — Protocol No 4 concerning certain provisions relating to Ireland — Protocol No 5 concerning the treatment that may be applied by Switzerland to imports of certain products subject to the scheme for building up compulsory reserves — Final Act — Joint Declarations — Unilateral Declarations (OJ L 300, 31.12.1972, pp. 189-280)

See consolidated version.

last update 24.07.2018

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