Many manufacturers do not understand what mutual recognition agreements (MRAs) are or how they will affect their businesses. Some manufacturers do not believe that they will be affected at all, and in some cases that is true. But manufacturers marketing electrical and electronic devices outside North America are likely to have their products affected by these MRAs. And electrical and electronic devices are not the only products covered by MRAs. Markets, such as pharmaceuticals, recreational craft, medical devices, and telecommunications, and issues, such as product safety, are also addressed in the agreements. This article, however, will address only issues concerning the EMC market sector.

One Standard, One Test

MRAs are designed to provide for recognition of the results of conformity assessment procedures produced by the other party's conformity assessment bodies. Ultimately, the goal of the MRA scheme would be to have only one standard, one test, and one accreditation accepted globally. Ideally this would allow manufacturers to meet global marketplace and regulatory requirements to market their products worldwide.

MRAs are not agreements intended to provide for mutual acceptance of standards or technical regulations. MRAs will not affect legislation concerning declarations of conformity, registration, or enforcement in a product sector.

MRAs are being negotiated between virtually all developed countries. Curently, the United States is actively negotiating MRAs with the European Union (EU), the Asian Pacific Economic Cooperation (APEC), and the Inter-American Commission on Telecommunication (CITEL).

Mutual recognition is necessary for many reasons, and the reasons that most affect the manufacturing process include

Mutual recognition can and will increase access of U.S. products to foreign markets and vice versa. This is particularly true in regulated sectors. Another aim of MRAs is to streamline the U.S. conformity assessment system and promote the acceptance of conformity assessment among U.S. states and cities. The ultimate goal is to provide worldwide access to all products to allow for quicker time to market, as well as to decrease costs for assessment, accreditation, certification, and the like.

MRAs will be implemented in two phases. Phase I is a confidence-building period. Mutual recognition of conformity assessment bodies (CABs) will take place. Mutual recognition of test reports will be as follows: CABs in countries that have MRAs with the United States will exchange test reports in this phase. The reports will be reviewed by the U.S. CAB, and that CAB will issue the certification or certificate of compliance necessary for the manufacturer to declare compliance. Parties to the MRA will recognize CABs designated by the other party's designating authority. Each party will provide the other party with a list of recognized technical regulations. The designating authorities will provide a list of the accreditation bodies they will appoint for accrediting CABs. They will also provide a list of the nominated CABs. The transition period between the United States and EU officially started in December 1998. The following text was issued by NIST, reviewed by the FCC, and given to the U.S. Council of EMC Laboratories (USCEL) on February 8, 2000. The text also includes information about telecommunications and recreational craft. This information applies only to the U.S.–EU MRA.

 

The Transition Phase

During the transition period, U.S. manufacturers will contract with a U.S. CAB (for the sector of interest) to perform tests to assess conformance of the manufacturer's product to the essential requirements specified in the relevant EU directive or directives falling within the scope of the MRA. Depending on the directive, a U.S. CAB will generate the necessary test reports, a technical construction file or a certification report, and any related documentation required. The U.S. CAB will then enter into an agreement with an EU competent body (in case of EMC, Directive 89/336/EEC, Article 10(2) only) or an EU notified body (in case of all other sectoral annexes) to review and approve the conformity assessment documents. The competent body or the notified body will review the documentation, compile any additional information necessary, and issue under its responsibility the appropriate certificate (EU type examination certificate or another as applicable). This will allow the manufacturer to affix the CE mark and place the product on the EU market.

U.S. CABs can form commercial relationships with EU notified or competent bodies to facilitate this process. Manufacturers are also free to contract with U.S. CABs for services related to the MRA and to contract separately with a notified or competent body of their choice.

The sectoral annexes of the U.S.–EU MRA also describe transitional arrangements. Following are relevant excerpts from the MRA's EMC Sectoral Annex, Section VIII, Transitional Arrangement.

 

The agreement also refers manufacturers to the relevant annexes of EMC Directive 89/336/EEC.

Annex to the Telecommunications Ministerial Declaration
Indicative schedule for early voluntary sectoral liberalization in the mutual recognition agreement on conformity assessment for telecommunications equipment. (The designation [PARA] indicates a paragraph in the MRA for referral.)
	Mutual Recognition of Test Reports (Phase I)	Mutual Recognition of Equipment Certifications (Phase II) {PARA}
Australia	Australia already accepts test reports from other parties.	Suppliers¹ declarations are accepted now. Australia does not require certification.
Brunei Darussalam	2003	2003[PARA]
Canada	End of 1998	End of 1999[PARA]
Chile[PARA]	See footnote*	See footnote*
China	2002 for network terminals	To be advised[PARA]
Hong Kong, China	Already in effect	2­3-month process required[PARA]
Indonesia	2005	To be advised [PARA]
Japan	July 1999	July 1999[PARA](targeted, but could be 2000)
Korea	July 1999	To be advised[PARA]
Malaysia	2003	2003[PARA]
Mexico	June 2001	To be advised[PARA]
New Zealand	See footnote**	See footnote**[PARA]
Papua New Guinea	December 2001	To be advised[PARA]
Peru	[PARA]December 2001	To be advised
Philippines	2005	2006[PARA]
Russian	Federation [PARA] To be advised	To be advised
Singapore	July 1999	End of 1999[PARA]
Chinese Taipei	Already in effect	2000[PARA](targeted, but could be 2001)
Thailand	2004	2006[PARA]
United States	FCC currently accepts test data from other parties.	July 1999[PARA]
Vietnam	[PARA] To be advised	To be advised
* The APEC MRA was accomplished as part of a multisectoral approach to liberalization in the region's economies, including nine different industry sectors. The telecom MRA is one of these sectors. As Chile prefers not to approach liberalization on a sector-by-sector basis, it cannot yet commit to implementing the MRA.
** The responsibility for setting the standards for attachment to telecommunications networks in New Zealand rests with network operators, not the government—except insofar as electrical safety and electromagnetic compatibility are concerned. Recognizing its potential to contribute toward removal of NTMs in the APEC region, New Zealand proposes to endorse the MRA.

Review of EU Test Report

Designated EU CABs under the MRA may test products to U.S. (FCC) requirements (as specified under the MRA) in Europe and produce test reports for equipment subject to Declaration of Conformity (DoC) under Parts 15 and 18 of FCC rules. A U.S. CAB must review these test reports for completeness. During the MRA transition period, the U.S. CAB must be accredited by A2LA or NVLAP for the relevant scope in accordance with ISO/IEC Guide 25 in order for the manufacturer to use the test reports to support the DoC procedure.

 

 

APEC MRA

Text for the CITEL MRA was completed on October 29, 1999. The text is essentially the same as for the APEC MRA. Several countries have already started the process. Up-to-date information can be found on http://www.citel.oas.org, as well as on the FCC and NIST Web sites.

 

Conclusion

It seems that things are moving along, albeit at an antagonizingly slow pace. But the wheels of progress, bureaucracy, and government do turn slowly. In any case, it will not be that long, and manufacturers will be able to decrease much of the redundant work now required to place products into certain market sectors. Nations have recognized that today's business pace, especially in the electronic arena, is moving much faster, and they can no longer hinder the process with unnecessary assessments, certifications, and regulations. Time to market is a driving force throughout the industry. Multinational companies are demanding a level playing field in all the countries in which they market their products. MRAs—whether good, mediocre, or bad—are the means for addressing the situation.

 

Gary Fenical is senior EMC manager for Instrument Specialties (Delaware Water Gap, PA).