The significance of the Radio Equipment Directive in mechanical and plant engineering

On April 16, 2014, the European Commission published the Radio Equipment Directive 2014/53/EU, or RED for short. This legislation has been in force in all member states of the Union since June 13, 2016 and has since regulated the provision of radio equipment on the market.

In addition to that, the directive is significant in the interaction with machinery products, as machines with a permanently installed radio element are considered radio equipment. As a result, manufacturers of such products must also comply with the requirements of the RED Directive in addition to the Machinery Directive and any other directives.

Moreover, a November 2021 decision is important for manufacturers of machinery: in a published implementing regulation, the Commission has extended the scope of the Radio Equipment Directive to include machines with a "radio function" that can communicate with the Internet and thus - regardless of the medium - must meet specific security requirements.

This article provides a brief overview of the Radio Equipment Directive and its interaction with the manufacture of machines with radio equipment. It also provides insight into the current significance of the directive with regard to cybersecurity aspects of Internet-enabled machines. 

1. General information on the radio equipment directive

The Radio Equipment Directive ensures in the EU "an adequate level of electromagnetic compatibility and the effective and efficient use of radio spectrum to avoid harmful interference"¹. Above all, however, like all EU legislation, the directive is intended to ensure the free movement of goods in the Union market for the electrical equipment covered.  

Scope of application

The products covered by the Radio Equipment Directive are broad, according to Article 2.1 the definition of a radio equipment is "an electrical or electronic product intended to transmit and/or receive radio waves for the purpose of radiocommunication and/or radiolocation (...)". If one goes by this definition, any product becomes a radio installation as soon as it emits or receives radio waves - which is equally true, for example, for a machine with such a function when incorporated into another product.  

Support from standards

To support the implementation of the health and safety requirements of the directive in radio equipment, the European Commission has commissioned the standardization organization ETSI² to draw up and revise harmonized standards. These are intended to assure manufacturers that the requirements of the RED have been met when they are applied. At present, around 150 standards fulfil the directive's presumption of conformity.  

2. Interaction with the Machinery Directive 2006/42/EC

The Guide to the Radio Equipment Directive explains in chapter 1.6.3.1 that non-radio products (e.g. machines, toys, medical devices, kitchen appliances, luminaires, ...) can function together with radio equipment. In this context, the Radio Equipment Directive stipulates that products with a permanently integrated radio element are radio equipment within the meaning of the Directive. This does not apply to products that are merely connected to such an installation. Integration can therefore be assumed if the built-in radio installation is built into the non-radio product (=machine) and is permanently attached to the non-radio product, so that it cannot be removed from the machine without further ado.

If the non-radio product is a machine, the Machinery and Radio Equipment Directives must be applied together to the product. The Radio Equipment Directive refers to the contents of the Low Voltage Directive in terms of health and safety requirements - however, when two directives are applied, the safety requirements of the more specific legislation, in this case the Machinery Directive, apply to the overall product.

The permanent installation of a radio element in a machine thus creates a new overall product in accordance with the Radio Equipment Directive, for which an EU Declaration of Conformity must also be issued. If the manufacturer of the machine or the overall product has installed the radio equipment of another manufacturer (with CE marking), he can refer to the latter's declaration of conformity - this must not be affected by the installation in the machine!

If a radio element is subsequently added to a machine that has already been put into operation, it must be determined whether this represents a significant change to the machine. This would entail a conformity assessment procedure. In this case, a conformity assessment procedure would have to be carried out, regardless of whether the (modified) machine is used by the user or sold after modification.⁴

3. Security requirements for Internet-enabled machines

On 29.10.2021, within the framework of Delegated Regulation 2022/30, the Radio Equipment Directive was amended in its sections Article 3(3) (d-f). Here, it was specified that "radio equipment connected to the Internet" is also covered by the requirements of the RED. Thus, Internet-connected machines must not exert "any harmful effects on the network or its operation" and must ensure protection against fraud and protection of personal data.

A detailed explanation of this regulation and a link to the full text can be found in one of our technical articles.

To meet these requirements, the European standardization organizations (CEN, CENELEC and ETSI) have already been tasked with creating harmonized standards. In the "Joint Technical Committee - Cybersecurity and Data Protection", harmonized standards are being created for this purpose, such as a "General Framework for Sector-Specific Information Security or Cybersecurity Bundles of Measures". However, none of these standards have yet been published.

4. Notes for Safexpert users

Since July 2022, there is a new "Radio Equipment Directive (EU) data package" on the Safexpert Live Server. This data product ensures that Safexpert users are prepared for these innovations at an early stage.

The data package includes the bibliographical data of the published harmonized standards in the OJEU according to the Radio Equipment Directive, such as standard number, issue date, date of termination of presumption of conformity, etc. By continuously updating this standard data, you can keep your project documentation up to date at all times.

Here you can find further information on standard packages and data packages. 

Footnotes:
¹See Radio Equipment Directive 2014/53/EU
²The European Telecommunications Standards Institute, in short ETSI
³Summary list of titles and references of harmonised standards under Directive 2014/53/EU on radio equipment
⁴See position paper: „Die neue Funkanlagenrichtlinie: Anforderungen an Hersteller von Maschinen mit Funkeinrichtung“ (Zvei: Die Elektroindustrie)

Posted on: 2022-07-05

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