What are MRAs?
A Mutual Recognition Agreement (MRA) is an international agreement in which two or more countries agree to mutually recognise the results of conformity assessment by mutually notified conformity assessment bodies (CABs) for the scope of the agreement.
Since the establishment of the World Trade Organisation (WTO) in 1995, MRAs within and between different trading blocs, including APEC and the European Union, have become increasingly common.
What is the background and aim of MRAs?
Increasing global trade has raised serious concerns about the free movement of goods across borders for the following reasons:
- Unnecessary regulatory divergence between the legal systems
- Imposition of trade costs through tariffs and technical barriers to trade
As markets integrate across borders, there is growing awareness of the potential of international regulatory co-operation (IRC) to help policy makers remove potential barriers that unduly impede international trade. This has led the European Commission to conclude Mutual Recognition 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 harmonisation of compliance standards.
The designation of mutually recognised conformity assessment bodies (CABs) is an important step towards mutual agreements that allow EU authorities and their partners to work together:
- Relying on others' GMP inspection systems
- Exchange of information on inspections and quality defects
- No 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 correction
- Delays in the placement of products until they are ready for the market.
All of these trade facilitation measures are carried out without affecting the legal requirements in both countries.
What role do the conformity assessment bodies (CABs) for CE-certified products play in the MRA?
The core function of MRAs is the designation of CABs (conformity assessment bodies). An important condition in the mutual recognition agreements is the recognition of the results of conformity assessment (e.g. testing or certification) carried out by one Party (non-EU country) by the conformity assessment bodies (CABs) designated by the other Party (EU) in order to demonstrate conformity with the national legislation of the first Party (non-EU country) and vice versa.
Under the mutual recognition agreements, the regulatory authorities of the Member States may designate notified bodies in 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 recognition agreements. Links to the existing lists are included in this document.
Which countries have concluded agreements with the EU on the mutual recognition of conformity assessments?
Which countries have concluded agreements with the EU on the mutual recognition of conformity assessments?
- Australia
- Canada
- Israel
- Japan
- New Zealand
- Switzerland
- USA
What agreements exist for the mutual recognition of conformity assessments with the EU/CE conformity assessment?
Each member state has a specific agreement with the EU that covers a different area. Below you will find the links to the documented agreements under the MRA for each country
*Directive 2008/57/EC and EU-Switzerland land transport agreement - LTA list Switzerland
What is the scope of the Agreement on Mutual Recognition of Conformity Assessment with Australia and the list of authorised conformity assessment bodies specifically for Australia?
The following sectors are covered by the agreement between the EU and Australia:
- 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
What is the scope of the Agreement on Mutual Recognition in relation to Conformity Assessment with Canada and the list of authorised conformity assessment bodies specifically for Canada?
The following sectors are covered by the agreement between the EU and Canada:
- 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
What is the scope of the Agreement on Mutual Recognition in relation to Conformity Assessment with Israel and the list of authorised conformity assessment bodies specifically for Israel?
The agreement between the EU and Israel covers GLP (Good Laboratory Practice).
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.
What is the scope of the Agreement on Mutual Recognition in relation to Conformity Assessment with Japan and the list of authorised conformity assessment bodies specifically for Japan?
The following sectors are covered by the agreement between the EU and Japan:
- Electrical products
- F&TTE
- GMP
- GLP
Conformity assessment centres
What is the scope of the Agreement on Mutual Recognition of Conformity Assessment with New Zealand and the list of authorised conformity assessment bodies specifically for New Zealand?
The following sectors are covered by the agreement between the EU and New Zealand:
- EMC
- Low-voltage devices
- Machinery
- Medical devices
- Pressure equipment
- TTE
- GMP
Conformity assessment centres
What is the scope of the agreement on mutual recognition of conformity assessments with Switzerland and the list of authorised conformity assessment bodies specifically for Switzerland?
The following sectors are covered by the agreement between the EU and Switzerland. For Switzerland, each sector is classified as a different chapter and a list of the different CABs for each chapter is given below:
- 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
What is the scope of the Agreement on Mutual Recognition of Conformity Assessment with the USA and the list of authorised conformity assessment bodies specifically for the USA?
The following sectors are covered by the agreement between the EU and the USA:
- 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 the USA
CABs authorised by the EU Member States
What further documentation or evidence is required if a CE-certified product is exported to a country that has not signed an EU MRA?
If an MRA applies to someone, they must first contact a CAB, which will test the product. Any CE-certified product can apply for an MRA certificate, i.e. an authorisation to trade in a country that is not a member of the EU but has signed the MRA.
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
What are the limits of mutual recognition agreements?
Mutual Recognition Agreement (MRA) are a limited option insofar as the conformity assessments of two countries are not really equivalent. 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.
How well do the MRAs work in practice?
According to a recent OECD survey, the Mutual Recognition Agreement (MRA) is generally working well. The benefits include the facilitation of cross-border trade and a broader range of goods and services.
