Notified Bodies and Mutual Recognition Agreements (MRAs)

In the field of radio equipment, conformity assessment and access to different markets are based on two key elements: notified bodies (ONs) and the agreements of mutual recognition (MRAs).

For questions and requests related to ONs and MRAs you can get in contact By the following routes:

Bodies notified under the RED Directive (2014/53/EU)

In Spain, the RED Directive has been incorporated into the legal system through Royal Decree 188/2016, of 6 May, approving the Regulation that establishes the requirements for the marketing, commissioning and use of radio equipment.

This regulation:

  • Define the figure of notified body for radio equipment in the Spanish context.
  • It regulates conformity assessment procedures and their relationship with notified bodies.
  • It determines the obligations of manufacturers, importers and distributors in relation to CE marking and technical documentation.

La notifying authority (AN) in Spain in the field of radio equipment is the State Secretariat for Telecommunications and Digital Infrastructures (SETELECO), which:

  • Designates conformity assessment bodies that can act as notified bodies for RED.
  • It notifies the European Commission and the other Member States of these bodies.
  • Supervises that they maintain their technical competence, impartiality and appropriate means.

In addition to this, the Spanish notified bodies are accredited by ENAC in the corresponding technical areas and offer both testing and certification services, so that they can accompany the manufacturer throughout the conformity assessment process in accordance with the RED Directive and Royal Decree 188/2016.

What are MRAs (Mutual Recognition Agreements)

Mutual Recognition Agreements (MRAs) are agreements between the European Union and other countries or regions whereby each party acknowledges the results of the conformity assessment (tests, certifications, etc.). carried out by bodies of the other party, for certain sectors and types of products.

In the area of telecommunications and radio equipment, an MRA may establish that:

  • Tests carried out in an EU-recognised laboratory are accepted by the regulatory authority of the third country, and vice versa.
  • Certificates issued by certain conformity assessment bodies are valid for regulatory purposes on both sides.

It is important to note that MRAs do not modify the technical requirements of the destination country: the equipment must continue to meet the specifications applicable in each market. What they simplify is the recognition of evaluation results, reducing duplication, costs and deadlines.

SETELECO as designating authority in MRAs

En España, la Secretaría de Estado de Telecomunicaciones e Infraestructuras Digitales (SETELECO) actúa como designating authority not only for bodies notified under the RED Directive, but also for bodies and laboratories involved in MRAs in the field of telecommunication and radio equipment.

Similar to what happens with the notified bodies RED, SETELECO:

  • Evaluates and designates the conformity assessment bodies and laboratories that can operate within the framework of the applicable MRAs.
  • It communicates these designations to the authorities of the European Union and to the counterparts of international agreements.
  • He supervises that these bodies maintain their technical competence, impartiality and the necessary means throughout the term of their appointment.

This guarantees that the results issued by designated bodies in Spain (test reports, certificates of conformity, etc.) can be recognized in the countries with which there is an MRA in force, providing legal certainty and trust to the regulatory authorities of the different markets.

MRAs, RED and "double marked"

For companies and manufacturers of radio equipment that are subject to the RED Directive and Royal Decree 188/2016, MRAs are especially useful when they want to market the same equipment in the European Union and in one or more third countries.

In these cases, a possible strategy is:

  • Design the team taking into account from the beginning the regulatory requirements of all target markets.
  • Carry out the tests and conformity assessment in an assessment body (laboratory and/or notified body) recognised under the applicable MRA and, where necessary, designated by SETELECO.
  • Use the same reports and certificates to obtain:
    • CE marking in accordance with the RED Directive (with the intervention of a notified body where applicable).
    • Regulatory approvals from the third country, when the MRA covers that type of product.

In this way, the manufacturer can achieve a "double marking": to have the CE marking for the EU market and, in parallel, the marking or certification required in other markets, with an optimized testing process and without the need to fully repeat the conformity assessment in each country.

Before planning a double marking, it is recommended to verify:

  • If the country of destination has an MRA in force with the EU covering radio equipment or the corresponding sector.
  • If the selected conformity assessment bodies (laboratories and notified bodies) are recognized within the scope of that MRA and, in the case of Spain, designated by SETELECO.
  • How to coordinate documentary and labelling requirements so that the product can be marketed in all target markets without further modifications.