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Mutual Recognition Agreements

European companies that wish to export to Australia, Canada, Japan, New Zealand, the USA, Israel or Switzerland need to know about Mutual Recognition Agreements (MRAs) and the designated Conformity Assessment Bodies (CABs).

Mutual Recognition Agreements

Mutual Recognition Agreements (MRAs) promote trade in goods between the European Union and third countries and facilitate market access. They are bilateral agreements, and aim to benefit industry by providing easier access to conformity assessment.

Conformity Assessment Bodies

Mutual recognition agreements lay down the conditions under which one Party (non-member country) will accept conformity assessment results (e.g. testing or certification) performed by the other's Party (the EU) designated conformity assessment bodies (CABs) to show compliance with the first Party's (non-member country) requirements and vice versa.

MRAs include relevant lists of designated laboratories, inspection bodies and conformity assessment bodies in both the EU and the third country. Links to existing lists are provided on this website.

List of mutual recognition agreements

Australia

Text of Agreement:

Sectors:

  • Automotive products
  • EMC
  • Low Voltage Equipment
  • Machinery
  • Medical Devices
  • Pressure Equipment
  • TTE
  • GMP

Conformity Assessment Bodies

Canada

Text of Agreement:

OJ L 280 of 16/10/1998

Sectors - the MRA between the EU and Canada is operational for the following sectors:

  • TTE
  • Recreational Craft

Conformity Assessment Bodies:

List of approved conformity assessment bodies designated by Canada

List of approved conformity assessment bodies (CABs) designated by the EU Member States

Israel

Text of Agreement:

OJ L 263 of 9/10/99

Sectors - the MRA between the EU and Israel covers the GLP.

Japan

Text of Agreement:

OJ L 284 of 29/10/2001

Sectors - the MRA between the EU and Japan is operational for the following sectors:

  • Electrical products
  • R&TTE
  • GMP
  • GLP

Conformity Assessment Bodies

New Zealand

Text of Agreement:

OJ L 229 of 17/08/1998

OJ L 356 of 22/12/2012

Sectors - the MRA between the EU and New Zealand is operational for the following sectors:

  • EMC
  • Low Voltage Equipment
  • Machinery
  • Medical Devices
  • Pressure Equipment
  • TTE
  • GMP

Conformity Assessment Bodies

Switzerland

Text of Agreement:

OJL 114, 30/04/2002

Sectors - The MRA between the EU and Switzerland is operational for the following sectors:

  • Machinery (Chapter 1)
  • Personal Protective Equipment (Chapter 2)
  • Toys (Chapter 3)
  • Medical Devices (Chapter 4)
  • Gas appliances and boilers (Hot water boilers) (Chapter 5)
  • Pressure vessels (Chapter 6)
  • Radio Equipment and Telecommunication Terminal Equipment (Chapter 7)
  • Equipment and protective systems intended for use in potentially explosive atmospheres (Chapter 8)
  • Electrical equipment (Chapter 9)
  • Construction plant and equipment (Chapter 10)
  • Measuring instruments and pre-packages (Chapter 11)
  • Motor Vehicles (Chapter 12)
  • Agricultural and forestry tractors (Chapter 13)
  • Good Laboratory Practice - GLP (Chapter 14)
  • Medicinal products, Good Manufacturing Practice (GMP), inspection batch and certification (Chapter 15)
  • Construction products (Chapter 16)
  • Lifts (Chapter 17)
  • Biocidal products (Chapter 18)
  • Cableways (Chapter 19)
  • Explosives for civil use (Chapter 20)

Conformity assessment bodies:

  1. to be found in the NANDO database

  2. NOT in the NANDO database:

Chapter 12

Swiss authoritiespdf Choose translations of the previous link  (199 KB) responsible for type-approval, technical services and testing bodies under motor vehicles chapters.

Chapter 13

Swiss authoritiespdf Choose translations of the previous link  (89 KB) responsible for type-approval, technical services and testing bodies under motor vehicles chapters.

Chapter 14

(Good Laboratory Practice-GLP)

For the purpose of this Sectoral Chapter, 'Conformity Assessment Bodies' means the test facilities recognised under the GLP monitoring programme of each Party.

Chapter 15

(Medicinal products, Good Manufacturing Practice (GMP) inspection and batch certification)
For the purpose of this Sectoral Chapter, 'Conformity Assessment Bodies' means the official GMP inspection services of each Party.

Chapter 18

(Biocidal products)

For the purposes of this Sectoral Chapter, “Conformity Assessment Bodies” means the competent authorities of Switzerland for placing biocidal products on the market: Federal Office of Public Health, Notification Authority for Chemicals

List of approved conformity assessment bodies (CABs) designated by the EU Member States

  1. to be found in the NANDO database
  2. not in the NANDO database:

Chapter 11 (Measuring instruments and prepackages)

For the purpose of this Sectoral Chapter, 'Conformity Assessment Bodies' also means Competent Authoritiespdf Choose translations of the previous link  (80 KB) (verification services and laboratories) responsible for calibration.

Chapter 12 (Motor vehicles) and 13 (Agricultural or forestry tractors)

For the purpose of these Sectoral Chapters, 'Conformity Assessment Bodies' means the authorities responsible for type-approval, technical services and testing bodies.

Chapter 14 (Good Laboratory Practice-GLP)

For the purpose of this Sectoral Chapter, 'Conformity Assessment Bodies' means the test facilities recognised under the GLP monitoring programme of each Party.

Chapter 15 (Medicinal products, Good Manufacturing Practice (GMP) inspection and batch certification)
For the purpose of this Sectoral Chapter, 'Conformity Assessment Bodies' means the official GMP inspection services of each Party.

Chapter 18 (Biocidal products)

For the purposes of this Sectoral Chapter, “Conformity Assessment Bodies” means the competent authorities of the Member States of the European Union

USA

Text of Agreement

OJ L 31 of 04/02/1999

Sectors - the MRA between the EU and the USA is operational for the following sectors:

  • EMC
  • Telecommunication Equipment

Conformity Assessment Bodies:

List of approved conformity assessment bodies designated by the USA

List of approved conformity assessment bodies (CABs) designated by the EU Member States

Guidance documents and references of regulations

  • Conformity assessment guides for EC designating authorities, EC conformity assessment bodies and European industry relating to Australia and New Zealand, Canada and the USA
  • Guide on the mutual recognition agreement between the EC and Japan
  • Implementation of Mutual Recognition Agreements on conformity assessment (MRA) and Protocol on European Conformity Assessment (PECA) Document Certif. 98/7 of 24.07.1998pdf Choose translations of the previous link  (46 KB)
  • Procedure for designation of conformity assessment bodies under an MRA and its annexes
    Document Certif. 96/3 Rev. 6 of 14.06.2001pdf Choose translations of the previous link  (43 KB)
  • Specifications concerning assessment and supervision of systems applying to Conformity Assessment Bodies (CABs) with a view to their designation under MRAs Document Certif. 96/1 of 26.06.1996pdf Choose translations of the previous link  (22 KB)