EU approval (MED)
Approval of marine equipment
In implementation of the international requirements, the approval of marine equipment in the EU is regulated by the Marine Equipment Directive (MED) and its respective implementing regulations.
The implementing regulations contain an exhaustive list of marine equipment for which harmonised requirements already exist. If harmonised requirements do not yet exist, national approval by the flag state is required.
In the case of MED approval, the manufacturer may affix a symbolic wheel mark as a conformity mark, the identification number of the notified body and the year of marking to the equipment. Equipment marked in this way can be placed on the market, installed on board and used throughout the EU without further national approval.
Marine Equipment Directive – MED
The European Directive 2014/90/EU (PDF, 1MB, Not barrier-free file.)is the essential set of rules on the subject of marine equipment. Among other things, it regulates the approval procedure for marine equipment on ships under European flags.
The list of marine equipment subject to approval with the applicable performance and testing standards is published in the respective MED implementing regulations. Currently, this is the Implementing Regulation (EU) 2019/1397 (PDF, 1MB, Not barrier-free file.). The following areas are covered in principle:
- life-saving appliances
- marine pollution prevention
- fire protection equipment
- navigation equipment
- radio-communication equipment
- equipment required under COLREG 72
- other safety equipment
- equipment under SOLAS Chapter II-1
- equipment for which the set of standards for MED certification is not complete (MED approval is therefore not possible)
EU conformity assessment bodies (notified bodies)
For MED approval, a specific conformity assessment procedure must be carried out. This procedure can be ordered by the manufacturer from any notified body in the EU. The approvals by a notified body are valid throughout the EU.
EU conformity assessment procedure
The conformity assessment procedure is defined in Annex II of the MED. It usually consists of a combination of type examination (module B) and a quality assurance module (modules D, E or F). In individual cases an individual test (module G) may be carried out. With the exception of individual testing, proper approval always consists of a module combination (B + D, B + E or B + F). For each successfully tested module, the notified body will issue a MED certificate.
After receipt of the certificates, the conformity assessment procedure is concluded with the issue of the declaration of conformity by the manufacturer. He also affixes the conformity mark (wheel mark symbol) as well as the identification number of the notified body and the year of marking to the product. You will find an overview of marine equipment approved throughout Europe in the MarED database.
EU Declaration of Conformity
By issuing the EU Declaration of Conformity (DoC), the manufacturer declares that his product complies with the requirements of the Marine Equipment Directive. With this declaration, the manufacturer assumes the responsibility and obligations according to Article 12 paragraph 1 MED. The EU Declaration of Conformity must be carried on board as a central accompanying document. An overview of the essential contents of an EU Declaration of Conformity has been drawn up by the European market surveillance authorities.
Mutual recognition agreement EU – USA
Since 2004 there has been a Mutual Recognition Agreement (MRA) between the EU and the USA for tests and approvals under Directive 96/98/EC on marine equipment. Although Directive 96/98/EC has now been replaced by Directive 2014/90/EU, the original MRA with the US remains in place as it has not yet been adapted to the new Directive 2014/90/EU. The Annex to the MRA contains a list of marine equipment to which this Agreement may apply.
The website of the American Coast Guard (USCG) contains information on the current design of the MRA. In addition to the MRA, the USA accepts tests carried out in recognised laboratories (Accepted Laboratories). The USCG maintains a database for this purpose. The BSH test laboratory was recognized for individual aspects.