Compliance steps for marine equipment: essential information for the manufacturers

To sell in the European Union, marine equipment manufacturers need to comply with Directive 2014/90/EU, the Marine Equipment Directive (MED). This Directive applies to all equipment on board of ships registered under EU flags and the European Free Trade Associations (EFTA).

What products are covered by the Marine Equipment Directive?

The Directive applies to equipment placed or to be placed on board an EU ship and for which the approval of the flag State administration is required by the international instruments. In this sense, the Directive aims to increase marine safety and reduce pollution, covering various products, from navigation instruments and life-saving appliances to radio-communication and protection equipment. In brief, the MED covers the following products:

  • Life-saving appliances
  • Marine pollution prevention equipment
  • Fire protection equipment
  • Navigation equipment
  • Radio-communication equipment
  • Collision-preventing equipment
  • SOLAS (Safety of Life at Sea) equipment

How to affix the wheel mark: conformity assessment routes

All marine equipment must bear the MED mark of conformity, namely the “Wheel Mark”. The “Wheel Mark” is proof of conformity with the Marine Equipment and is an equivalent of the CE marking on other EU-compliant products.

To affix the wheel mark, the products must demonstrate compliance through third-party conformity assessment procedures and following testing standards. Notified bodies carry out third-party conformity assessment procedures, whereas testing standards are standards set by nine different entities. Some of the entities issuing standards for marine equipment are the International Maritime Organization (IMO), International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), European Committee for Standardization (CEN), and European Committee for Electrotechnical Standardization (Cenelec).

Documents necessary for a compliant file

Manufacturers of marine equipment must compile the technical documentation for their products as per Annex II, module G, point 2. The technical documentation should enable to assess the marine equipment’s conformity. Some of the core documents to include in the technical documentation are test reports, design calculations results, and a list of the requirements and testing standards for those specific products including a description of the solutions adopted to meet the requirements.

Together with the technical documentation, a compliant file also includes the Declaration of Conformity, labels, and IFUs, among other things.

Authorised Representative for marine equipment

As per Article 13, non-EU manufacturers wishing to sell marine equipment for EU-flagged ships must appoint an authorised representative. The authorised representative’s tasks include keeping the manufacturer’s documentation at the disposal of national surveillance authorities and cooperating with competent authorities to eliminate any risks the products might represent.

Obelis can act as your authorised representative in the European Union and checks your documents to guide you through the compliance process.

Check out our dedicated Library for Documents!

References:

European Commission. (2014). Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC. Retrieved on 04/04/2023.

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