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.

Scope

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.

Applicability

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:

• equipment exclusively used for public security and defence activities;
• equipment covered by other specific EU instruments governing the conformity of the equipment with the essential requirements;
• airborne products, parts and appliances referred to in European Regulation (EC) 216/2008;
• marine equipment falling within the scope of Council Directive 96/98/EC; and
• custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

For a full list of exclusions please refer to the regulations.

Obligations of manufacturers

The obligations of manufacturers of radio equipment include:

1. Before placing radio equipment on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements and that they have had a relevant conformity assessment procedure carried out and technical documentation drawn up.
2. Once this has been done, a manufacturer must draw up the EU Declaration of Conformity and affix the CE marking to the product.
3. Manufacturers must keep technical documentation and the EU Declaration of Conformity for 10 years after the radio equipment has been placed on the market.
4. Manufacturers must also label radio equipment with their name, registered trade name or registered trademark and postal address; the type, batch or serial number (or other identification) and ensure that accompanied by relevant instructions and safety information in a language easily understood by the end user. If the end user is in the Malta, the language must be either in Maltese or in English.
5. When placing radio equipment on the market, the manufacturer must ensure that it is accompanied by information concerning any restrictions on putting into service or requirements for authorisation of its use.
6. The manufacturers must put procedures in place to ensure that series production remains in conformity with the regulations.
7. When appropriate, the manufacturers must take action to monitor equipment made available on the market by them which may present a risk or is not in conformity with the regulations, keeping a register of such equipment and any complaints or actions taken. They must immediately inform the market surveillance authority of any radio equipment that presents a risk.
8. They must also cooperate with and provide information to enforcing authorities following any requests.

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:

1. They must comply with all the duties as specified in the mandates, including the obligation for retention of technical documentation and EU Declaration of Conformity, and the provision of information and co-operation.

Obligations of importers

The obligations of importers include:

1. Before placing radio equipment on the market, an importer must ensure that it is in conformity with the essential requirements and that the obligations in the regulations are met. If the radio equipment presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.
2. The importer must ensure that the relevant conformity assessment has been carried out by the manufacturer; the manufacturer has drawn up technical documentation and EU Declaration of Conformity; the radio equipment is CE marked and is accompanied by the required documents and information regarding the manufacturer.
3. The importer must keep a copy of the EU Declaration of Conformity and technical documentation for a period of 10 years after the equipment has been placed on the market.
4. The importer must provide their name, registered trade name or registered trademark and a postal address at which they can be contacted, on the radio equipment.
5. The importer must ensure that when placing radio equipment on the market, it is accompanied by instructions and safety information, which can be easily understood by end user in the Member State where it is to be made available. If the end user is in Malta, that language must be either in Maltese or in English.
6. The importer must also ensure that the radio equipment is accompanied by information concerning any restrictions on putting into service or requirements for authorisation of its use.
7. The importer must ensure that the radio equipment under their responsibility is safely stored and transported, remaining in conformity with the regulations.
8. The importer must, when appropriate, with regards to any risk posed to consumers, carry out sample testing of equipment and investigate complaints about radio equipment that is not in conformity with the regulations and keep a register of those complaints.
9. The importer must take action where they have reason to believe that the radio equipment that they have placed on the market is not in conformity with the regulations.
10. They must also cooperate with and provide information to enforcing authorities following any requests.

Obligations of distributors

The obligations of distributors include:

1. Before making radio equipment available on the market, a distributor must act with due care to ensure that it is in conformity and that the obligations in the regulations are met. If the radio equipment presents a risk, the distributor must inform the manufacturer or importer and the market surveillance authority of that risk.
2. They must verify that the equipment bears the CE marking, is accompanied by the required documents and by instructions and safety information, either in Maltese or in English. The distributor must also make sure that the obligations on the manufacturer and importer regarding their identification has been complied with.
3. The distributor must not make non-conforming equipment available on the market, until the equipment has been brought into conformity with the regulations.
4. The distributor must take action where they have reason to believe that the equipment that they have made available on the market is not in conformity with the regulations.
5. The distributor must ensure that equipment under their responsibility are safely stored and transported, remaining in conformity with the regulations.
6. They must also cooperate with and provide information to enforcing authorities following any requests.

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

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.

Further Information

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/

The Malta Communications Authority (MCA) is the responsible local authority that manages and protects the radio spectrum. The MCA website provides more information on the radio spectrum, here.

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