Recently, the European Commission’s Group of Administrative Co-operation Under the Radio Equipment Directive 2014/53/EU has issued the Information sheet on obligations associated with the placing on of radio equipment on the market. The sheet is a non-binding act that lays down the administrative requirements for placing equipment on the market and aims to assist in the interpretation of requirements. Let’s take a look!
Conformity Assessment
The manufacturer must perform a conformity assessment in order to demonstrate the essential requirements set out in art.3 of the Radio Equipment Directive 2014/53/EU (the RED) are fulfilled). The assessment must also consider the reasonably foreseeable conditions. On the other hand, if the radio equipment is capable of taking different configurations, the conformity assessment must confirm whether the radio equipment meets the essential requirements for all configurations indeed [1].
Manufacturers must demonstrate compliance by taking one of the conformity assessment paths:
- Internal production control – set in Annex II of the RED;
- EU-type examination followed by the conformity to type based on internal production control – set in Annex III of the RED;
- Conformity based on full quality assurance – set in Annex IV of the RED.
Compliance paths described in Annex III and Annex IV must be applied if a harmonised standard published in the Official Journal has not been applied, has been applied partially, or does exist [2].
The importer must ensure the manufacturer has taken the appropriate conformity assessment path [3].
Only once compliance has been demonstrated, manufacturers can draw up an EU declaration of conformity and affix the CE marking.
Technical documentation
Manufacturers must draw up the technical documentation (TD) before the products are placed on the market and keep it for 10 years after the placing on the market [4]. The content of it is described in Annex V, but it must always include an analysis and assessment of the risks. The TD must be continuously updated.
Importers must also keep a copy of Declaration of Conformity for 10 years after the placement on the market, at the disposal of the authorities upon their request [5].
EU Declaration of Conformity
The structure and elements of the Declaration can be found in Annex VI of the RED. If the product is subject to more EU legislations requiring the EU Declaration of Conformity, a single EU declaration of conformity must list of all the relevant EU legislations [6]. It can also be in the form of a dossier with all the individual declarations.
Manufacturers must assure that every product is accompanied by either:
- A copy of the EU declaration of conformity; or
- A simplified EU declaration of conformity – containing the internet address with the full text of the declaration and all elements set out in Annex VII.
Importers and distributors should also check if the radio equipment is accompanied by the EU Declaration of Conformity.
Identification and traceability of the radio equipment
Radio equipment must bear on them or where the size or nature of radio equipment does not allow it, on its packaging, or in a document accompanying the radio equipment:
- Type, batch/serial number or other element for identification [7];
- the name, registered trade name or registered trademark of the manufacturer and the postal address at which they can be contacted;
- The name, registered trade name or registered trademark of the importer and the postal address at which they can be contacted.
CE-Marking and NB-Identification Number
The CE marking must be affixed visibly, legibly and indelibly on both:
- The product or to its data plate (unless that is not possible due to the nature of the product);
- The packaging.
The height of CE marking is 5mm with some exceptions detailed in article 19.
If the taken conformity assessment path is the one from Annex IV, the CE marking is to be followed by the identification number of the notified body the tests.
Instructions and safety information
Instructions and safety information must be clear, understandable and in accordance with the intended use of the product. If a product is subject to restrictions, the restriction must be indicated in the packaging and additional information about the type of restriction must be provided it in the accompanying documents in a language that is easily understood by end-users.
The following information shall also be included if the radio equipment intentionally emits radio waves:
- Frequency band(s) in which it operates;
- Maximum radio-frequency power transmitted in the frequency band(s) in which it operates.
Nika Gavrilovic
24/08/2020
Regulatory Affairs department
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[1] Art. 17(1) RED
[2] Art. 17(4) RED
[3] Art. 12(2) RED
[4] Art. 10(3) and Art. 10(4)
[5] Art. 12(8)
[6] Art. 18(3) RED
[7] Art. 10(6) RED