Equipment installed on board ships may perform functions that are critical to survival, navigation, fire protection, pollution prevention and safe operation. For ships flying the flag of an EU Member State, specified marine equipment is therefore subject to a dedicated European conformity framework.
Directive 2014/90/EU — commonly known as the Marine Equipment Directive or MED — establishes requirements for marine equipment to be placed on board EU ships where international maritime conventions require approval by the flag State administration.
MED conformity differs significantly from conventional CE marking. Compliant marine equipment within the Directive’s scope normally carries the distinctive Wheel Mark rather than the CE marking as evidence of conformity under the MED.
The technical requirements are closely connected with international maritime instruments and testing standards. Manufacturers therefore need to establish not only whether the MED applies, but also the current requirements and testing standards applicable to the particular equipment item.
This GAR Insight explains MED scope, equipment categories, international maritime requirements, testing standards, conformity assessment modules, Notified Body involvement, technical documentation, the EU Declaration of Conformity and application of the Wheel Mark.
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Explore MED scope, marine equipment categories, international requirements, testing, conformity assessment, technical documentation and Wheel Marking.
Understanding Directive 2014/90/EU
Directive 2014/90/EU establishes the European conformity framework for specified marine equipment intended to be placed on board ships flying the flag of an EU Member State.
Its objectives include enhancing safety at sea, preventing marine pollution, ensuring uniform application of relevant international instruments and facilitating the free movement of compliant marine equipment within the European Union.
Which Marine Equipment Is Covered?
The MED applies to equipment that is required by relevant international instruments to be approved by the administration of the flag State when it is placed or is to be placed on board an EU ship.
This means that a product does not fall within the MED simply because it is used at sea or installed on a vessel. The regulatory status of the specific equipment item must be established.
EU Ship
The Directive focuses on marine equipment placed or intended to be placed on board ships flying the flag of an EU Member State.
Approval Requirement
The relevant international conventions must require approval of the equipment by the flag State administration.
Listed Equipment
The current implementing regulation identifies individual equipment items and the corresponding design, construction, performance and testing requirements.
Equipment-Specific Assessment
Scope should therefore be determined against the actual equipment description and current regulatory requirements, rather than from the manufacturer’s commercial product category.
Main Marine Equipment Categories
The MED framework encompasses numerous types of safety-critical marine equipment. The applicable requirements depend on the individual item and the international instruments governing it.
Life-Saving Appliances
Equipment associated with survival, evacuation and rescue, including various life-saving appliances used aboard ships.
Marine Pollution Prevention
Equipment used to support compliance with international requirements concerning prevention of pollution from ships.
Fire Protection Equipment
Fire detection, firefighting, protective and related equipment may fall within the MED framework.
Navigation Equipment
Navigation and navigational safety equipment can be subject to MED approval and performance requirements.
Radio-Communication Equipment
Certain shipboard radio and communication equipment is subject to marine equipment conformity requirements.
Other Shipboard Equipment
Additional categories are included where international instruments require flag-State approval.
MED & International Maritime Requirements
One of the defining characteristics of the MED is its relationship with international maritime law and technical standards.
The Directive implements within the EU framework requirements arising from relevant international conventions, resolutions, circulars and testing standards.
SOLAS
The International Convention for the Safety of Life at Sea is fundamental to many marine safety and equipment requirements.
MARPOL
The International Convention for the Prevention of Pollution from Ships establishes requirements relevant to certain pollution-prevention equipment.
COLREG
International collision-prevention requirements are relevant to specified navigational equipment and shipboard arrangements.
IMO Instruments
IMO resolutions, codes and circulars can establish detailed performance and testing requirements for marine equipment.
Why the MED Implementing Regulation Matters
Directive 2014/90/EU establishes the legal framework, but a manufacturer also needs to identify the current implementing regulation applicable when the equipment is being assessed.
The implementing regulation identifies marine equipment items and links them to the applicable international design, construction, performance and testing requirements.
Directive 2014/90/EU
Establishes manufacturer obligations, conformity assessment, Notified Body requirements, marking, declarations and the overall EU marine equipment conformity system.
Current Implementing Regulation
Identifies covered marine equipment and the international design, construction, performance and testing requirements applicable to individual equipment items.
Testing & Type Approval
MED conformity commonly requires the manufacturer to demonstrate that equipment satisfies prescribed design, construction and performance requirements through the applicable testing standards.
Identify Requirements
Establish the exact MED equipment item and the international requirements referenced for that product.
Select Test Standards
Determine the testing standards applicable to the equipment under the current implementing regulation.
Define Test Specimen
Ensure the equipment submitted for assessment represents the product design intended for production.
Conduct Testing
Complete the required performance, environmental, functional or other testing applicable to the equipment.
Evaluate Results
Demonstrate that test results satisfy the acceptance criteria established by the applicable requirements.
Control Design Changes
Assess modifications to determine whether existing approval evidence remains representative of the manufactured equipment.
MED Conformity Assessment Modules
The Marine Equipment Directive uses conformity assessment modules combining examination of the product design with control or verification of production.
The precise permitted route depends on the applicable MED requirements and should be established before certification begins.
| Module | Function | General Purpose |
|---|---|---|
| Module B | EC Type-Examination | A Notified Body examines the technical design and verifies that the type meets the applicable requirements. |
| Module D | Production Quality Assurance | Conformity to type is supported through an approved production quality system. |
| Module E | Product Quality Assurance | An approved quality system provides control of final product inspection and testing. |
| Module F | Product Verification | Product conformity is verified through examination and testing under the applicable procedure. |
| Module G | Unit Verification | An individual item of marine equipment is independently assessed for conformity. |
The Role of the Notified Body
Notified Bodies perform the independent conformity assessment functions assigned to them under the MED.
Their role depends on the selected conformity route and can include examination of technical design, product verification, assessment of quality systems and surveillance.
Type Examination
The Notified Body evaluates whether the representative type satisfies the applicable MED requirements.
Technical Documentation
Relevant design, testing and product documentation is reviewed as required by the applicable module.
Quality-System Assessment
Where a quality-assurance route is used, the Notified Body assesses and monitors the manufacturer’s approved quality system.
Product Verification
Under verification routes, individual products or appropriate samples may be examined and tested as required.
Maintaining Production Conformity
Certification of a representative type does not by itself ensure that every subsequently manufactured product conforms.
Manufacturers therefore need appropriate production controls to ensure that Wheel-Marked products remain consistent with the approved design and applicable MED requirements.
Approved Design
Production specifications should correspond with the design assessed during conformity assessment.
Supplier Control
Safety-critical materials and components should remain consistent with approved specifications.
Manufacturing Control
Production processes should be controlled where they can affect product performance or regulatory conformity.
Inspection & Testing
Appropriate production inspection and testing should confirm continued conformity.
Change Control
Design and component changes should be assessed before implementation.
Traceability
Product and production records should allow conformity evidence to be linked to the equipment placed on the market.
MED Technical Documentation
Technical documentation provides the evidence demonstrating that marine equipment satisfies the applicable design, construction, performance and testing requirements.
EU Declaration of Conformity
When conformity has been demonstrated, the manufacturer draws up an EU Declaration of Conformity confirming that the marine equipment fulfils the applicable requirements.
By drawing up the declaration, the manufacturer assumes responsibility for the conformity of the equipment.
Product Identity
The declaration must be connected unambiguously to the marine equipment it covers.
Manufacturer
The responsible manufacturer and relevant identification information should be stated.
Applicable Requirements
The declaration should identify the applicable conformity framework and relevant technical requirements.
Notified Body
Relevant Notified Body and conformity assessment information should be identified as required.
The Wheel Mark
The Wheel Mark is the distinctive conformity marking established for marine equipment under Directive 2014/90/EU.
It indicates that the equipment has been demonstrated to comply with the applicable MED requirements through the required conformity assessment procedure.
CE Marking
Used under numerous EU product-safety and conformity frameworks where the applicable legislation requires CE marking.
Wheel Mark
The distinctive conformity marking used for equipment conforming with the Marine Equipment Directive.
Common MED Compliance Problems
Assuming All Marine Products Need MED
A product is classified from its marine use without checking whether it is actually subject to MED approval requirements.
Using Outdated Requirements
Testing is based on an earlier implementing regulation or obsolete international standard.
Wrong Equipment Item
The product is matched to an incorrect regulatory equipment description, resulting in the wrong test programme.
Testing Before Classification
Laboratory work begins before the applicable MED item and testing standards have been established.
Type Certificate Only
Type examination is incorrectly treated as the complete conformity assessment without addressing production conformity.
Uncontrolled Product Changes
Components, materials, software or construction are changed without evaluating their effect on the existing approval.
Wrong Marking
CE marking is treated as a substitute for the MED Wheel Mark.
Incomplete Technical File
Test reports, drawings, certificates and production records do not correspond with the equipment actually manufactured.
From MED Classification to Wheel Marking
A structured MED strategy establishes the regulatory requirements before significant testing and certification expenditure begins.
Define Equipment
Establish product design, function and intended shipboard use.
Confirm MED Scope
Determine whether Directive 2014/90/EU applies.
Identify MED Item
Match the equipment with the current regulatory item.
Map Requirements
Identify applicable international instruments and performance criteria.
Select Test Standards
Establish the required standards and applicable editions.
Select Conformity Route
Determine the permitted type and production assessment modules.
Select Notified Body
Confirm appropriate notification scope for the equipment.
Conduct Testing
Complete the required technical and performance evaluations.
Complete Type Assessment
Obtain applicable type-examination evidence.
Control Production
Complete the applicable production conformity procedure.
Declare Conformity
Prepare the EU Declaration of Conformity.
Apply Wheel Mark
Mark compliant marine equipment according to MED requirements.
From Marine Equipment Approval to Demonstrable EU Conformity
Marine Equipment Directive conformity begins by establishing the regulatory identity of the product. Manufacturers need to determine whether the equipment is subject to Directive 2014/90/EU and identify the exact marine equipment item applicable to the product.
That classification connects the equipment with the relevant international maritime instruments, design and performance requirements and testing standards. Only then can an appropriate testing and conformity assessment programme be established.
Where type examination forms part of the selected route, the approved type must remain connected to controlled production. Materials, components, manufacturing processes and product changes therefore become part of the continuing conformity system.
The resulting technical documentation, test evidence, Notified Body certification, production-conformity evidence and EU Declaration of Conformity should all describe the same equipment ultimately carrying the Wheel Mark.
The Technical Question
Has the equipment been tested against the international design, construction and performance requirements currently applicable to its MED equipment item?
The Conformity Question
Can the manufacturer demonstrate that every Wheel-Marked product placed on the market continues to correspond with the design, testing and conformity assessment on which its approval is based?