Subsidiary Legislation 427.41, Radio Equipment Regulations, transposes Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC.
The Radio Equipment Directive (RED) establishes a regulatory framework for placing radio equipment on the market, while ensuring a single market by setting essential requirements for health and safety, electromagnetic compatibility, and the efficient use of the radio spectrum.
The Directive and regulations apply to all equipment which emits or receives radio waves for radiodetermination (i.e. determining the position, velocity or other characteristics of an object using radio waves) or communication purposes. This includes devices such as mobile phones, car door openers and modems.
There are a number of important exclusions, including:
For a full list of exclusions please refer to the regulations.
Obligations of manufacturers
The obligations of manufacturers of radio equipment include:
Obligations of authorised representatives
Manufacturers are able to appoint authorised representatives, by written mandates, to perform certain tasks on their behalves. The manufacturers’ obligations for the radio equipment to be designed and manufactured in accordance with the essential requirements and to draw up the technical documentation, shall not be part of these mandates.
The obligations of authorised representatives include:
Obligations of importers
The obligations of importers include:
Obligations of distributors
The obligations of distributors include:
Obligations of manufacturers applying to importers and distributors
Importers or distributors are considered manufacturers for the purposes of the regulations and they are subject to the obligations of the manufacturers, where they place radio equipment on the market under their name or trademark or modifies the equipment already placed on the market in such a way that compliance with the regulations may be affected.
Enforcement and penalties
The enforcing authority for radio equipment, in relation to protection and management of the radio spectrum is the Malta Communications Authority (MCA), and for other aspects including safety of radio equipment is the Market Surveillance Directorate (MSD), within the MCCAA.
The regulations provide powers to enforcing authorities to take action against economic operators for products that are not in conformity with the regulations. Economic operators are required to co-operate with the enforcement authorities and on request, must provide information and take action as appropriate.
Under the regulations and the RED Directive, member states have a duty to take action in relation to equipment presenting a risk at national level and where the market surveillance authority consider any non-compliance is not restricted to their national territory, they must inform the European Commission and other EU Member States. Where this procedure has been initiated by another member state, the local enforcing authorities are required under the regulations to take action in relation to the equipment and must inform the European Commission and other member states thereof.
The regulations also allow the enforcing authorities to raise an objection against the measures taken by another Member State. The European Commission will determine whether the action taken is justified; if so, the MSD must take necessary measures to ensure radio equipment is withdrawn from the market. Where the European Commission finds the action taken by the Member State initiating the measures, is not justified, that Member State must withdraw that measure.
Economic operators failing to comply with the requirements of the regulations are subject to the provisions of article 26 of the Product Safety Act.
Notified Bodies are independent organisations appointed by EU Member State governments and notified to the European Commission to carry out the procedures for conformity assessment and certification set out in the regulations.
A list of Notified Bodies appointed under the regulations, may be found on the NANDO website.
Economic operators are free to select any suitable Notified Body from any Member State.
The European Commission has produced detailed guidance on the provisions of the RED Directive and its requirements, which should be referred to for further guidance. This guidance can be found at: https://ec.europa.eu/growth/sectors/electrical-engineering/red-directive_en
The European Commission has produced guidance regarding CE marking, which can be found at: https://ec.europa.eu/growth/single-market/ce-marking
The European Commission has produced guidance called the Blue Guide intended to contribute to a better understanding of EU product safety rules and to their more uniform and coherent application across different sectors and throughout the single market. The Blue Guide can be found at: http://ec.europa.eu/DocsRoom/documents/18027/
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