MECA Report Types
The following is a list of report types offered by MECA, with descriptions of what is provided.
Informative Report (often referred to as CB Style Report, Compliance Reports)
An Informative Report is issued by MECA and utilizes the IECEE Test Report Form (TRF), which is a report template controlled by the IECEE CB Scheme. This report style includes a verdict for all the clauses that are being evaluated per the applicable standard(s). This report can be tailored to the manufacturer’s needs as MECA is not required to evaluate all requirements of the applicable standards. It is important to note that what MECA does not evaluate, the manufacturer will be responsible for providing evidence of compliance. This report type is accepted by the FDA, Health Canada, EU Notified Bodies for CE Marking, and nearly all International Agencies (except for South Korea, limited in Brazil, and China at this time). It does not authorize the use of a certification mark by itself; a NRTL Certification Report is required for this. An Informative Report is essentially identical to a CB Report, but it does not have an IECEE CB Scheme Certificate/License and is not reviewed & issued by MECA’s NCB.
Accredited Report
An Accredited Report is an Informative Report that is issued by MECA under the scope of our A2LA Accreditation and bears our A2LA Accreditation Mark. The only difference between an Informative Report and an Accredited Report is the A2LA Accreditation Logo being applied to the Test Report. For an Informative Test Report to also be Accredited, MECA must follow the A2LA Accreditation rules and the standards applied must be in MECA’s Scope of Accreditation. Any subcontracted testing must also be conducted at a facility that is accredited by A2LA or an accrediting body that is recognized by A2LA.
CB Report (National Certification Body Report)
A CB Report is issued by IECEE CB Scheme members and is a program managed by the IECEE. CB Reports are generated by MECA but issued by our NCB after it is passed through an additional non-technical review. To issue this report type, MECA must perform a clause-by-clause assessment of compliance with all requirements of the applicable standards. The official purpose of a CB Report is to allow for the exchange of test data between Certification/NRTL labs. This allows a manufacturer to test with one lab and obtain multiple certification marks. It can also be used for regulatory purposes without needing to retest in country. A CB Report does not authorize the use of a certification mark by itself; a NRTL Certification Report is required for this. It is the same as an Informative Test Report, but it includes a CB Certificate that is valid for 3 years from the issue date.
*Note, at this time, CB Reports cannot be issued for MECA EMC projects.
NRTL Certification Report (with authorization to apply a US/Canada Safety Mark)
A NRTL Certification Report is issued by a Certification Agency, not MECA. MECA has partnerships with several Certification Agencies. This report typically an Inspection Report (for the OSHA Required Production Inspections) and are generally support by either an Informative Report or a CB Report where full compliance with the necessary standards are documented. Each NRTL has their own program requirements that define what standards are acceptable or required to obtain certification. A NRTL Certification report authorizes the manufacturer to apply the NRTL Safety Mark (e.g. UL, TUV Rheinland, TUV SUD, CSA, ETL (Intertek), MET Labs, Bureau Veritas, etc.). Obtaining an NRTL Mark/NRTL Certification Report requires audits to be conducted at the device’s factory(ies). Audits are typically conducted biannually or quarterly depending on the Certification Agency. A NRTL Certification Report is used to verify the equipment is manufactured the same as the sample that was tested, and that production line testing is being performed.
*Note, NRTL Certification Reports do not require compliance to EMI/EMC standards.
ASCA Summary Test Report
An ASCA Summary Test Report is issued by MECA and is intended to be submitted to the FDA along with the manufacturer’s Declaration of Conformity in order to support the 510(k) submission. It is a summary of the Informative Report or CB Report associated with the device’s evaluation.
Letter Report
A Letter Report is issued by MECA and aims to summarize the findings of our limited evaluation. It does not utilize the IECEE Test Report Form (TRF) and instead is a template created by MECA. This report can be tailored to the manufacturer’s needs depending on the evaluation/testing being conducted. Letter Reports are often provided for the limited evaluation required to conduct clinical studies or to provide the manufacturer with information regarding their device. A Letter Report can include the following:
- Applicable standards being applied
- Device Information
- Intended Use
- Device Description
- Essential Performance Description
- Evaluation Information
- Scope of Evaluation
- Accompanying Documents & Markings Reviewed
- Construction Reviewed
- Risk Management Documentation Reviewed
- Usability Documentation Reviewed
- Software Development Life-Cycle Documentation Reviewed
- Testing Information
- Summary