A review of the relevant obligations, from CE marking to on-pack information
Adopted in 2014, transposed into European Union (EU) Member State legislation in 2014-16 and then subject to a transitional phase-in that ran until the end of 12 June 2017, the EU’s Radio Equipment Directive (RED) is not new legislation. Even so, its manufacturer obligations have only had mandatory application over the last couple of years.
This article takes a look at these obligations noting that, while many of them are the same as those found in other CE marking legislation like the Low Voltage and EMC Directives, others are of a more specific nature and unique to the RED. For the latter, it is also notable that the European Commission has yet to propose some of the supplementary legislation – “delegated acts” – foreseen by the RED and intended to fully detail particular obligations. Combined with the delay in the referencing of RED harmonized standards in the Official Journal of the European Union, this is a situation that makes complying with the RED a challenge for manufacturers supplying into the EU and necessitates closely following developments in both legislation and European standardization.
RED Scope and the Definition of a “Manufacturer”
As a starting point, the RED applies to “radio equipment” – something that is defined in the Directive’s Article 2.1(1) as:
“…an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radio determination.”
Examples of in-scope equipment are mobile radio transceivers, mobile phones, Wi-Fi and Bluetooth equipment, satellite transceivers including GPS receivers, domestic television and radio sets and radar equipment.
As a CE marking Directive aligned with the EU’s New Legislative Framework (NLF), the RED specifies obligations for four types of economic operator: manufacturers, authorized representatives of manufacturers, importers and distributors. This article is concerned with one of these, manufacturers. The RED uses the definition for manufacturers found in all NLF aligned product laws, which is as follows (in this case referring to radio equipment as the product):
“A ‘manufacturer’ means any natural or legal person who manufactures radio equipment or has radio equipment designed or manufactured, and markets that equipment under his name or trademark.”
RED Manufacturer Obligations Consistent With Those Obligations Found in Other NLF-Aligned Product Laws
These are as summarized in Table 1.
|Technical documentation||Manufacturers must prepare and retain technical documentation for 10 years after placing their radio equipment on the EU market. It is to contain at least the nine elements that are referenced a) to i) in Annex V of the RED.|
|Declaration of Conformity||Manufacturers must prepare and retain a Declaration of Conformity (DoC) for 10 years after placing their radio equipment on the EU market. The DoC is to be written in a particular way, with its “model structure” found in Annex VI of the RED.|
|Affixing the CE marking to radio equipment||This is to be done in accordance with Article 30 of Regulation (EU) No 765/2008. This stipulates that: a) the CE marking is to be affixed only by the manufacturer or his authorized representative; b) this affixing indicates that the manufacturer takes responsibility for the conformity of the radio equipment with all applicable requirements set out in relevant legislation; and c) for the EU, the CE marking is to be the only legal marking to attest legal conformity. Minimum size (i.e., height of no less than 5mm) and format obligations also apply.|
|Provision of instructions and safety information||Manufacturers must ensure that radio equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Instructions are to include the information required to use the radio equipment in accordance with its intended use. Instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible. The following information shall also be included “in the case of radio equipment intentionally emitting radio waves”: a) frequency band(s) in which the radio equipment operates; and b) maximum radio frequency power transmitted in the frequency band(s) in which the radio equipment operates.|
|Traceability||Manufacturers must ensure that procedures are in place for the series production of radio equipment to remain in conformity. Manufacturers must ensure that radio equipment bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the equipment does not allow it, that the required information is provided on radio equipment packaging or in a document accompanying the radio equipment.|
|Sample testing, register and corrective actions||
When deemed appropriate with regard to any health and safety risks presented by radio equipment, manufacturers are obliged to carry out sample testing, investigate, and, if necessary, keep a register of a) complaints, b) non-conforming radio equipment, and c) product recalls, and shall keep distributors informed of any such monitoring.
Manufacturers that consider or have reason to believe that their radio equipment, once placed on the EU market, is not in compliance with the RED, must immediately take the necessary corrective measures to bring the radio equipment into conformity, to withdraw it or recall it, if appropriate, and immediately inform the competent national authorities of the Member States in which it made the radio equipment available to that effect, giving details of the non-compliance and of corrective measures taken.
Manufacturers are additionally obliged to respond to reasoned requests from market surveillance authorities.
|Harmonized standards and the presumption of conformity||For manufacturers, the RED provides a presumption of conformity with its essential requirements when the radio equipment is designed and constructed in accordance with relevant harmonized standards, references to which are found in the EU Official Journal.|
Table 1: General manufacturer obligations found in CE marking legislation
RED-Specific Manufacturer Obligations
There are several of these, which are now introduced and discussed in turn.
Radio equipment must be of a construction that ensures: a) the health and safety of people and domestic animals are protected consistent with Low Voltage Directive Annex I safety objectives, but with no voltage limits applying; and b) an adequate level of electromagnetic compatibility as set out in the EMC Directive. The radio equipment must also be “so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference” (Article 3(2) of the Directive).
In addition to the above, the RED envisages certain categories or classes of radio equipment (yet to be determined by the European Commission) are to provide:
- Interwork with accessories, in particular with common chargers;
- Interwork via networks with other radio equipment;
- Connection to interfaces of the appropriate type throughout the EU;
- That no harm is caused to networks or their functioning, nor are network resources misused;
- Protection of personal data and privacy of the user and subscriber;
- Protection from fraud; and
- Access to emergency services via certain features, equally that specific features a) facilitate use by users with a disability, and b) ensure that software can only be loaded into equipment when the compliance of the combination of the radio equipment and software has been demonstrated.
Ensure Operation in at Least One Member State
The RED requires manufacturers to ensure that radio equipment can be operated in at least one EU Member State without infringing applicable requirements concerning the use of the radio spectrum. These requirements are specified by spectrum management authorities in each EU Member State and reflected in their national frequency allocation plans.
Provision of Information on Compliance Combinations
Manufacturers must provide EU Member States and the European Commission with information on the compliance of intended combinations of radio equipment and software with the RED’s essential requirements. Such information shall result from a conformity assessment (see below) and shall be given in the form of a statement of compliance that includes the elements set out in the RED’s Annex VI (i.e., the Declaration of Conformity). Depending on the specific combinations of radio equipment and software, the information shall precisely identify the radio equipment and the software that have been assessed, and shall also be continuously updated.
Registration of Certain Categories of Radio Equipment
Manufacturers of certain, yet-to-be-specified categories of radio equipment must register their products with an envisaged “central system” to be implemented by the European Commission (pending at the time of writing). Future registration is envisaged to entail supplying some or all of the technical documentation that a radio equipment manufacturer is expected to compile and retain (see Annex V of the RED).
Manufacturers must undertake conformity assessment. This is to consider all intended operating conditions and, with respect to meeting Low Voltage Directive Annex I safety objectives, the assessment shall also take into account reasonably foreseeable conditions. The RED offers a choice of conformity assessment procedure, that is, internal production control,
EU-type examination, or conformity based on full quality assurance. These are, respectively, Modules A, B, C and H of Annex II of Decision 768/2008/EC.
It is worth elaborating further on these procedures, as follows:
- Internal production control (Module A): This relates to a manufacturer’s own controls with the manufacturer then declaring radio equipment compliance on the basis of technical documentation compiled, checks undertaken in manufacturing and by ensuring relevant markings are affixed (e.g., the CE marking, but also anything required by relevant harmonized standards applied such as input/output ratings and insulation class). A Declaration of Conformity is also to be written. One important point to note with respect to internal production control is that, for manufacturers that wish to employ harmonized standards but do not necessarily have equipment/expertise to test against them, it is likely to extend to third party product testing/certification. This can make the title “internal production control” a little misleading. In circumstances where the manufacturer has not applied harmonized standards, or else only in part, then they cannot use Module A and must use Module B or H.
- EC-type examination (Module B): This procedure differs from internal production control since conformity assessment will always involve a third party – a “Notified Body” – to examine radio equipment technical design, and to verify and attest that this design meets relevant legal requirements.
- Conformity to type based on internal production control (Module C): This conformity assessment procedure is, in effect, a merger of Modules A and B described in the preceding bullets.
- Conformity based on full quality assurance (Module H):
This conformity assessment procedure combines elements of internal production control (specifically, compilation of technical documentation) with examination, by an EU Notified Body, of a manufacturer’s quality system.
Additional On-Product Information
Depending on a manufacturer’s choice of conformity assessment procedure, this will include a Notified Body number (this is not relevant when Module A, internal production control, is pursued by a manufacturer).
Where restrictions on putting into service or requirements for authorization for use of radio equipment exist, RED Article 10(10) requires manufacturers to add information on radio equipment packaging that allows the identification of the EU Member States – or the geographical area(s) within an EU Member State – where these restrictions or requirements exist. Further information on the actual restrictions or requirements shall be completed in the instructions accompanying the radio equipment.
Commission Implementing Regulation (EU) 2017/1354 specifies how to present the information. In particular, the Implementing Regulation provides two options on how the information can be presented on the packaging. The manufacturer may either provide, visibly and legibly, a brief written statement or a pictogram (as illustrated) on the packaging. The pictogram is available to download from the European Commission website at https://ec.europa.eu/growth/sites/growth/files/pictogram-red.png (see Figure 1).
A Complex and Still-Evolving Product Law
At least compared to the Low Voltage and EMC Directives, the RED is a relatively complex product law specifying obligations that manufacturers of in-scope radio equipment must consider and address before placing their products on the EU market.
Even if manufacturers choose to use an EU Notified Body for conformity assessment purposes and get a third-party certification as a result, they would be wrong to assume full RED compliance. For example, are their products traceable in practice? Has operation in at least one Member State been confirmed? Are they monitoring what is happening with regards to the European Commission determining categories of radio equipment for future registration? These are just a few questions that radio equipment manufacturers should be mindful of in their regulatory compliance management (i.e., it is not just a case of achieving
Although the RED was adopted as EU law five years ago, in many ways it is still taking shape – we can expect supplementary legislation in the years ahead. For manufacturers of in-scope radio equipment supplying into the EU, it will be important to keep on top of this and be conversant with how things like registration play out. Watch this space.