Electronics Guide

Structure of MRAs

MRAs typically operate at multiple levels. At the most basic level, they may recognize the competence of testing laboratories in partner countries to perform tests according to the importing country's requirements. More comprehensive agreements extend this recognition to certification bodies, allowing a certificate issued in one country to be accepted directly in another.

The scope of an MRA defines which product categories and which regulatory requirements are covered. Some agreements are limited to specific sectors, such as telecommunications equipment or medical devices, while others take a broader horizontal approach covering multiple product categories. Understanding the scope is critical for determining whether a particular MRA applies to a given product.

MRAs require ongoing maintenance and periodic review to ensure that the regulatory frameworks in both jurisdictions remain compatible. Changes to standards, testing methods, or regulatory requirements in one jurisdiction may necessitate updates to the agreement or additional conformity assessment activities.

Key International MRAs

Several significant MRAs facilitate EMC compliance in international trade:

EU-US MRA: The agreement between the European Union and the United States covers various sectors including telecommunications equipment and electromagnetic compatibility. It allows designated conformity assessment bodies in each jurisdiction to test and certify products for the other market.

APEC TEL MRA: The Asia-Pacific Economic Cooperation Telecommunications MRA establishes a framework for mutual recognition of conformity assessment for telecommunications and radio equipment among participating economies, including EMC requirements.

Trans-Tasman MRA: The agreement between Australia and New Zealand creates a single market for regulated goods, with conformity assessment performed in either country accepted throughout the region.

CETA: The Comprehensive Economic and Trade Agreement between Canada and the European Union includes provisions for mutual recognition of conformity assessment in various sectors.

Practical Application of MRAs

Utilizing MRAs effectively requires careful attention to procedural requirements. Manufacturers must ensure that testing and certification are performed by bodies that are properly designated under the relevant agreement. Not all laboratories or certification bodies in a partner country may be covered by an MRA.

Documentation requirements under MRAs may differ from those for domestic certification. Manufacturers should verify the specific documentation, marking, and record-keeping obligations that apply when using the MRA pathway.

MRAs typically require that testing be performed to the importing country's standards, even if the testing facility is located in the exporting country. This means that a US laboratory testing for EU market access must test according to EU EMC standards and the CE marking requirements, not US FCC requirements.

Type Approval Systems

Type approval is a conformity assessment procedure in which a regulatory authority or designated body evaluates a representative sample of a product type and, upon finding it compliant, issues an approval that covers all products of that type. This approach is common in markets with strong regulatory oversight traditions.

The type approval process typically involves:

• Submission of an application with technical documentation
• Testing of representative samples at approved laboratories
• Evaluation of test results by the approval authority
• Issuance of a type approval certificate specifying the approved configuration
• Ongoing obligations regarding production conformity and change notification

Type approval certificates typically specify the exact product model and configuration that has been approved. Modifications to the product may require a new type approval or an amendment to the existing approval, depending on the nature of the changes and the specific requirements of the approving authority.

Countries using type approval systems for EMC include Japan (through its VCCI and Giteki marks for certain products), South Korea (KC mark), and various other Asian and Middle Eastern markets.

Self-Declaration Procedures

Self-declaration, also called Supplier's Declaration of Conformity (SDoC), allows manufacturers to declare that their products meet applicable requirements without mandatory third-party involvement. This approach places responsibility for compliance directly on the manufacturer or importer.

Under self-declaration systems, manufacturers must:

• Ensure that products are tested according to applicable standards
• Maintain technical documentation demonstrating compliance
• Issue a declaration of conformity
• Apply required markings to products
• Respond to regulatory inquiries and provide documentation on request

Self-declaration does not mean that testing is optional. Manufacturers are still required to have their products tested according to applicable standards. The difference is that a government body or notified body does not need to approve the test results before the product enters the market.

The European Union uses self-declaration for EMC compliance under the EMC Directive for most product categories. The United States FCC uses self-declaration (called Supplier's Declaration of Conformity) for many unintentional radiators, while intentional radiators typically require certification by an accredited Telecommunication Certification Body.

Third-Party Certification

Third-party certification involves an independent organization evaluating product compliance and issuing a certificate or approval. This approach provides additional assurance to regulators and consumers but adds time and cost to the market access process.

Third-party certification may be:

Mandatory: Required by regulations for certain product categories or markets. In these cases, products cannot legally be placed on the market without certification from an authorized body.

Voluntary: Available as an option for manufacturers who wish to obtain independent verification of compliance, even when not required by regulations. Voluntary certification may provide commercial advantages through increased buyer confidence.

The certification body's scope of accreditation determines which product categories and standards it can certify. Manufacturers should verify that the chosen certification body is properly accredited and recognized for the specific product type and target market.

Modular Conformity Assessment

Some regulatory frameworks, notably the European Union, use a modular approach to conformity assessment. Different modules define different combinations of design examination, production control, and testing activities that can satisfy regulatory requirements.

For EMC under EU regulations, the typical modules are:

Module A (Internal Production Control): The manufacturer conducts all conformity assessment activities internally, without mandatory involvement of a notified body. This is the default for EMC compliance under the EMC Directive.

Module B + C (EU Type-Examination + Conformity to Type): A notified body examines a representative sample and issues an EU type-examination certificate. The manufacturer then ensures production conformity to the approved type. This is less commonly used for EMC alone but may be required for products covered by multiple directives.

The choice of conformity assessment module affects documentation requirements, marking obligations, and the role of notified bodies in the compliance process.

Accreditation Fundamentals

Accreditation is the formal recognition that a certification body or testing laboratory is competent to perform specific conformity assessment activities. Accreditation bodies evaluate organizations against international standards such as ISO/IEC 17025 for testing laboratories and ISO/IEC 17065 for certification bodies.

Accreditation provides confidence that:

• The organization has appropriate technical competence and equipment
• Quality management systems are in place and functioning
• Personnel are qualified for the activities they perform
• Results are accurate, reproducible, and traceable

Accreditation is typically granted for specific scopes, defining the test methods, standards, and product categories for which the organization is recognized as competent. Using a laboratory or certification body for activities outside its accredited scope may result in unrecognized or invalid results.

International Accreditation Systems

Two primary international organizations facilitate mutual recognition of accreditation:

ILAC (International Laboratory Accreditation Cooperation): ILAC administers the mutual recognition arrangement for laboratory accreditation. Accreditation bodies that are signatories to the ILAC MRA agree to recognize the accreditation granted by other signatories, facilitating international acceptance of test results.

IAF (International Accreditation Forum): IAF provides a similar function for certification body accreditation. The IAF MLA (Multilateral Recognition Arrangement) enables recognition of certifications across national boundaries.

These arrangements mean that a test report from a laboratory accredited by an ILAC MRA signatory should be accepted by regulators and certification bodies in other signatory countries, reducing the need for duplicate testing.

Notified Bodies and Designated Organizations

In regulatory systems requiring third-party involvement, governments designate specific organizations to perform conformity assessment activities. The terminology varies by jurisdiction:

Notified Bodies (EU): Organizations designated by EU member states to perform conformity assessment activities under EU directives. Notified bodies are assigned identification numbers and listed in the NANDO database.

Telecommunication Certification Bodies (US): Organizations recognized by the FCC to certify equipment subject to certification requirements. TCBs must be accredited and designated under specific FCC procedures.

Conformity Assessment Bodies (various): The general term for organizations performing any conformity assessment activity, including testing, inspection, and certification.

Designation as a notified body or recognized certification body typically requires both technical accreditation and regulatory approval. The designation may be limited to specific product categories or regulatory requirements.

Selecting Appropriate Partners

When selecting testing laboratories and certification bodies, manufacturers should consider:

• Accreditation scope: Verify that the organization is accredited for the specific tests and standards required
• Regulatory recognition: Confirm that certifications will be accepted in target markets
• Geographic coverage: Consider whether the organization can support multi-market certification needs
• Technical expertise: Evaluate the organization's experience with similar products
• Service capabilities: Assess turnaround times, support services, and communication quality

Using a laboratory or certification body with broad international recognition can streamline multi-market compliance by reducing the need to work with multiple organizations in different countries.

Types of Technical Barriers

Technical barriers to trade in EMC take various forms:

Divergent standards: Different countries may use different technical standards with different limits, test methods, or frequency ranges. Products compliant with one standard may not meet another without modification.

Unique national requirements: Some countries impose requirements that differ from international standards without clear technical justification. These may include unusual test configurations, additional test parameters, or non-standard frequency bands.

Non-transparent procedures: Complex, unclear, or frequently changing regulatory requirements create uncertainty and compliance risk. Lack of published guidance or inconsistent interpretation of requirements adds to the burden.

Discriminatory treatment: Requirements that apply more stringently to imported products than to domestic products, or procedures that favor domestic testing and certification bodies.

Excessive documentation: Requirements for extensive documentation, translations, legalization, or local representation that go beyond what is necessary to verify compliance.

WTO TBT Agreement

The World Trade Organization Agreement on Technical Barriers to Trade (TBT Agreement) establishes principles to prevent technical regulations from becoming unnecessary obstacles to trade. Key principles include:

Non-discrimination: Technical regulations should not discriminate between domestic and imported products or between products from different trading partners.

Necessity: Regulations should not be more trade-restrictive than necessary to achieve legitimate objectives, such as protecting health, safety, or the environment.

Use of international standards: Countries should use relevant international standards as the basis for their technical regulations unless those standards would be ineffective or inappropriate for achieving the legitimate objective.

Transparency: Countries should notify proposed technical regulations to other WTO members and allow opportunity for comment before adoption.

Manufacturers who believe they face unjustified technical barriers can raise concerns through their national TBT enquiry point, which can pursue the matter through WTO channels if appropriate.

Addressing Barriers

Practical approaches to addressing technical barriers include:

Engagement with standards bodies: Participating in international standards development helps ensure that standards meet the needs of global trade. National positions in IEC and other international bodies influence the technical content of standards used worldwide.

Industry association advocacy: Trade associations can represent industry concerns to regulators and in international forums. Collective action is often more effective than individual company efforts.

Regulatory dialogue: Direct engagement with regulatory authorities can clarify requirements, address misunderstandings, and sometimes influence regulatory development.

Design for global compliance: Products designed from the outset to meet the most stringent international requirements are less likely to face market access barriers.

CB Scheme

The IECEE CB Scheme is a multilateral agreement for acceptance of test reports and certificates for electrical and electronic products. While primarily focused on safety, the scheme also covers EMC under its recognized certification bodies.

Key features of the CB Scheme:

• A CB Test Report issued by a recognized laboratory documents test results against IEC standards
• National Certification Bodies (NCBs) in member countries agree to accept CB Test Reports as the basis for national certifications
• National differences are documented and addressed through additional testing where necessary
• The scheme reduces duplicate testing while preserving national certification authority

For manufacturers, the CB Scheme allows efficient multi-market certification. A single test program, documented in a CB Test Report, can support certification applications in numerous countries, with only national differences requiring additional testing.

Regional Harmonization

Regional trade agreements often include provisions for regulatory harmonization or mutual recognition that facilitate market access within the region:

European Union: The EU's internal market allows free movement of goods that comply with EU directives. Products legally placed on the market in one member state can generally be sold throughout the EU without additional certification.

ASEAN: The Association of Southeast Asian Nations is developing harmonized technical regulations and mutual recognition arrangements to facilitate trade among member states.

Eurasian Economic Union: The EAEU (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan) has established common technical regulations that allow products certified in one member state to be sold throughout the union.

Gulf Cooperation Council: The GCC countries are working toward harmonized technical regulations and conformity assessment procedures.

Authorized Economic Operator Programs

Many countries have implemented Authorized Economic Operator (AEO) or trusted trader programs that provide benefits to companies with strong compliance records. While primarily focused on customs and security, these programs can also facilitate regulatory compliance:

• Reduced physical inspection of shipments
• Priority processing of import/export documentation
• Mutual recognition of AEO status between countries with bilateral agreements
• Enhanced relationship with regulatory authorities

Companies with AEO status may find it easier to navigate regulatory requirements and resolve compliance questions quickly.

Pre-Market Consultation

Many regulatory authorities offer mechanisms for pre-market consultation or preliminary review that can help manufacturers understand requirements before committing to full certification:

Pre-submission meetings: Some authorities allow manufacturers to discuss product characteristics and compliance strategies before formal submission, identifying potential issues early.

Advisory opinions: Written guidance on the applicability of requirements or the acceptability of proposed compliance approaches.

Draft documentation review: Some certification bodies offer preliminary review of technical documentation to identify gaps before formal evaluation.

Utilizing these mechanisms can reduce the risk of delays and rework during formal conformity assessment.

Market Prioritization

Not all markets are equally important for every product. Factors to consider when prioritizing markets include:

• Market size and potential: Larger markets may justify greater compliance investment
• Regulatory complexity: Some markets have simpler requirements that can be addressed quickly
• Standard alignment: Markets using similar standards may be efficiently addressed together
• Competitive requirements: Market presence may be necessary to match competitor offerings
• Customer requirements: Specific customer needs may drive market prioritization

A phased approach, addressing high-priority markets first while planning for broader expansion, can balance time-to-market pressures against resource limitations.

Test Planning for Multi-Market Compliance

Efficient test planning can minimize duplicate testing while ensuring coverage of all target market requirements:

Gap analysis: Compare requirements across target markets to identify common tests and unique requirements. Testing to the most stringent requirement often satisfies multiple markets.

Standard mapping: Identify which international standards are accepted in each market and plan testing to maximize recognition of results.

Laboratory selection: Choose laboratories with broad accreditation and international recognition to maximize the utility of test reports.

Parallel processing: Where possible, conduct testing and certification activities for multiple markets in parallel to reduce overall time to market.

Documentation Management

Comprehensive documentation supports efficient multi-market certification and ongoing compliance:

Technical file structure: Organize technical documentation in a logical structure that can be adapted to different market requirements with minimal effort.

Version control: Maintain clear version control for all compliance documentation, linking documentation versions to product versions.

Translation planning: Identify translation requirements for each market and plan translation activities efficiently.

Retention requirements: Understand and meet documentation retention requirements for each market, which may extend for many years after product discontinuation.