Subsidiary Legislation 427.35, Electromagnetic Compatibility Regulations, transposes Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility.

 

Scope

The Electromagnetic Compatibility (EMC) Regulations aim to ensure that electrical and electronic equipment complies with an adequate level of electromagnetic compatibility. It also lays down uniform rules to ensure protection against electromagnetic disturbance so as to guarantee the free movement of electrical and electronic equipment within the EU’s internal market.

 

Applicability

The Electromagnetic Compatibility Regulations applies to any product that contains active electronic components and hence are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance.

There are a number of important exclusions, including:

• equipment covered by other specific EU instruments governing the conformity of the equipment with the essential requirements;
• aeronautical apparatus, parts and appliances referred to in Regulation (EC) 216/2008; and
• equipment which is incapable of generating electromagnetic interference that is harmful to radio and telecommunication equipment.

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

The regulations do not apply to apparatus placed on the market before 13^th June 2016.

 

Obligations of manufacturers

The obligations of manufacturers of apparatus include:

1. Before placing apparatus 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 have a relevant conformity assessment procedure carried out and technical documentation drawn up.
2. Once this has been done, a manufacturer must draw up an 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 apparatus has been placed on the market.
4. Before placing apparatus on the market, the manufacturers must also label apparatus with their name, registered trade name or registered trademark and postal address; the type, batch or serial number (or other identification) and ensure that they are accompanied by relevant instructions and by information concerning the use of apparatus, in a language easily understood by the end user. If the end user is in Malta, the language must be either in Maltese or English.
5. They must take action where they have reason to believe that the apparatus that they have placed on the market is not in conformity with the regulations.
6. 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 apparatus 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 apparatus is placed on the market, an importer must ensure that the relevant conformity assessment has been carried out by the manufacturer.
2. The importer must ensure the manufacturer has drawn up technical documentation and EU Declaration of Conformity; the apparatus 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 apparatus has been placed on the market.
4. The importer must not place apparatus on the market unless it conforms with the essential requirements.
5. The importer must provide their name, registered trade name or registered trademark and a postal address at which they can be contacted, on the apparatus.
6. The importer must ensure that when placing apparatus on the market, it is accompanied by instructions and by information concerning the use of apparatus, 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 English.
7. The importer must ensure that apparatus under their responsibility is safely stored and transported, remaining in conformity with the regulations.
8. The importer must take action where they have reason to believe that the apparatus that they have placed on the market is not in conformity with the regulations.
9. 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 apparatus available on the market, a distributor must take due care to ensure that it is in conformity with the regulations, meaning that the apparatus is in conformity with the essential requirements and that each relevant economic operator has complied with their obligations imposed on them under the regulations.
2. They must verify that the apparatus bears the CE marking, is accompanied by the required documents as well as by instructions and information concerning the use of apparatus, either in Maltese or 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 apparatus available on the market if they think it is not in conformity with the essential requirements.
4. The distributor must take action where they have reason to believe that the apparatus that they have made available on the market is not in conformity with the regulations.
5. The distributor must ensure that apparatus 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 apparatus on the market under their name or trademark or modifies apparatus already placed on the market in such a way that compliance with the regulations may be affected.

 

Enforcement and penalties

The regulations provide powers to Market Surveillance Directorate (MSD), within MCCAA, 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 authority and on request, must provide information and take action as appropriate.

The MSD is required to take all appropriate measures to withdraw from the market or to prohibit or to restrict the supply of products bearing CE Marking which may endanger the health and safety of persons, property or the environment. The MSD must inform the European Commission and other EU Member States immediately of any enforcement action taken indicating the reason justifying that action. This will enable Member States to take action against similar products placed on the market on their territories. Similarly, if another Member State initiates the procedure with respect to action taken on their territories, certain actions are required of the local market surveillance authority.

The regulations also allow the MSD 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 electrical 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 EMC 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/emc-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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