Agreement on the mutual recognition of conformity assessments: (MRAs)

to mutually recognize conformity assessment bodies (CABs) within the scope of the agreement.

Since the establishment of the World Trade Organization (WTO) in 1995, MRAs have become increasingly common within and between different trading blocs, including APEC and the European Union.

• Unnecessary regulatory divergence between legal systems
• Imposition of trade costs through tariffs and technical barriers to trade

With the cross-border integration of markets, there is growing awareness of the potential of international regulatory cooperation (IRC) to help policymakers remove potential barriers that unduly hinder international trade. This has prompted the European Commission to conclude Mutual Recognition Conformity Assessment Agreements (MRAs) with markets outside the European Union.

MRAs are trade agreements designed to ensure consumer protection and compliance with local legislation:

• Facilitating market access without compromising national regulations
• Promote greater international harmonization of compliance standards.

The designation of mutually recognized conformity assessment bodies (CABs) is an important step towards mutual agreements that enable EU authorities and their partners to:

• Rely on others' GMP inspection system
• Exchange of information on inspections and quality defects
• Renunciation of imports into the other territory

The advantages of these MRAs include the avoidance of:

• Double checks
• Uncertainty about possible rejection due to minor differences in testing or verification, and their costly corrections
• Delays in placing products on the market.

All these trade facilitations take place without affecting the legal requirements in both countries.

which were carried out by one Contracting Party (non-EU country) by the Conformity Assessment Bodies (CABs) designated by the other Contracting Party (EU) in order to demonstrate compliance with the national legislation of the first Contracting Party (non-EU country) and vice versa.

Under the mutual recognition agreements, Member States' regulatory authorities can designate notified bodies within their own territory. The corresponding lists of notified laboratories, inspection bodies, and conformity assessment bodies, both in the EU and in the third country, are included in the mutual agreements. Links to the existing lists are included in this document.

• Australia
• Canada
• Israel
• Japan
• New Zealand
• Switzerland
• USA

*Directive 2008/57/EC and EU-Switzerland land transport agreement - LTA list Switzerland

• Automotive products: (The End-of-Life Vehicles Directive 2000/53/EC regulates automotive products. It is the first EU waste directive to introduce the concept of extended producer responsibility).
• EMC
• Low-voltage devices
• Machinery
• Medical devices
• Pressure equipment
• TTE: (Traditionally, the R&TTE Directive was the requirement for radio transmitters and receivers and telephone systems. The Radio Equipment Directive-RED has replaced the R&TTE. After June 2017, only the RE Directive is applicable).
• GMP: (Directives 91/356 and 91/412/EEC lay down the principles and guidelines of good manufacturing practice for medicinal products for human and veterinary use respectively).

Conformity assessment centres

• CABs authorised by Australia
• CABs authorised by the EU Member States

• Electrical and electronic equipment, including electrical systems and devices, as well as associated components: (The WEEE Directive and the Low Voltage Directive regulate the design and production of electrical and electronic equipment).
• Radio and telecommunications terminal equipment
• Electromagnetic compatibility (EMC)
• Toys
• Building products
• Machines including components and assemblies
• Measuring devices
• Hot water boilers, including associated appliances
• Devices for use in potentially explosive atmospheres (ATEX devices)
• Devices related to noise pollution in the environment
• Recreational craft, including their components

Conformity assessment centres

• CABs authorised by Canada
• CABs (testing laboratories) authorised by the EU Member States
• CABs (certification bodies) authorised by the EU Member States

The GLP principles (Good Laboratory Practice) validate data generated during the testing of chemicals by the GLP Directive 2004/10/EC of the European Parliament.

The GLP principles (Good Laboratory Practice) validate data generated during the testing of chemicals by the GLP Directive 2004/10/EC of the European Parliament.

• Electrical products
• F&TTE
• GMP
• GLP

Conformity assessment centres

• CABs approved by Japan
• CABs authorised by the EU Member States

• EMC
• Low-voltage devices
• Machinery
• Medical devices
• Pressure equipment
• TTE
• GMP

Conformity assessment centres

• CABs authorised by New Zealand
• CABs authorised by the EU Member States

• Machinery (Chapter 1)
• Personal protective equipment (Chapter 2)
• Toys (Chapter 3)
• Medical devices (Chapter 4)
• Gas appliances (chapter 5)
• Pressure vessel (chapter 6)
• Radio and telecommunications terminal equipment (R & TTE) (Chapter 7)
• Devices intended for use in potentially explosive atmospheres (chapter 8)
• Electrical equipment (Chapter 9)
• Construction machinery and equipment (Chapter 10)
• Measuring devices and prepackages (chapter 11)
• Motor vehicles (Chapter 12)
• Agricultural and forestry tractors (Chapter 13)
• Good Laboratory Practice - GLP (Chapter 14)
• Good manufacturing practice (GMP) for medicinal products, batch inspection and certification (Chapter 15)
• Building products (Chapter 16)
• Lifts (Chapter 17)
• Biocidal products (Chapter 18)
• Ropeways (Chapter 19)
• Explosives for civilian use (Chapter 20)

Conformity assessment centres

• To be found in the NANDO database
• Not in the NANDO database

List of CABs approved by the EU Member States

• which can be found in the NANDO database
• not in the NANDO database

• EMC
• Telecommunications equipment
• Ship equipment: (the current MED Directive 2014/90/EU of the European Parliament and of the Council on marine equipment has been in force since 18 September 2016).

Conformity assessment centres

• CABs authorised by New Zealand
• CABs authorised by the EU Member States

An MRA guarantees that a product manufactured in an exporting country has been certified by an accredited certification body (CAB) that has been "recognised" by the other importing country as part of the MRA procedures, without further tests or checks can enter the market of the importing country of destination and vice versa. For example, a device approved in Australia by the TGA, the Australian regulatory authority, is good enough to be placed on the EC market, most of the time anyway. EC certification under the MRA would be a largely administrative process rather than a further comprehensive assessment by the TGA. The entire MRA is based on the assumption that the requirements in Australia and the EC are equivalent, with the differences being considered insignificant.

This means that no additional proof or document is required if the product is already CE-certified. Only the national logo must in some cases be added to the CE labelling

The sole purpose is to avoid double testing in international trade and to facilitate the free market. Neither the regulatory objectives nor the technical requirements, nor the conformity assessment procedures are really equivalent in two countries.

In addition, MRAs can only be concluded for directives for which there is corresponding legislation in each contracting party. In the US, for example, there is no federal legislation covering the safety of machinery, so there is no MRA between the EU and the US on machinery. MRAs are therefore limited to different sectors of the economy.