The Marine Equipment Directive (MED) is a piece of legislation written by the European Commission to ensure the quality of marine equipment placed onboard European Flagged Ships. The aim of the Directive is to increase marine safety and reduce the risk of marine pollution. Directive 2014/90/EU stipulates that marine equipment to be installed on new or existing ships shall be approved to, and bear the MED mark of conformity, the “Wheel Mark”.
ABS, through its European Division, ABS Europe Ltd., has been involved from the outset in the development of the MED as one of the industry members in the working group meetings at the European Commission in Brussels. ABS Europe Ltd is also an active member of the MarED group of Notified Bodies that develop and implement the MED. Further information about MarED can be obtained from their website at: http://www.mared.org.
Designation of ABS Europe Ltd. as a Notified Body is under Regulation 4 of the Merchant Shipping (Marine Equipment) Regulations 2016 SI 2016/1025 as implementing Directive 2014/90/EU of the European Parliament and the council of July 23, 2014 on the Marine Equipment and repealing council Directive 96/98/EC as amended.
ABS Europe Ltd. is designated for the purposes of the approval and conformity assessment of marine equipment as detailed in Annex II of Directive 2014/90/EU and Merchant Shipping Notice 1874 (M+F) for the following types of Marine Equipment:
As a Notified Body, ABS Europe Ltd. can type approve the above types of equipment under the MED and issue EC Type-Examination (Module B) and Quality Assurance/Product Verification (Modules D or E/F) or Unit Verification (Module G) certificates.
On completion of approval process ABS Europe Ltd can authorize a manufacturer to stamp the product with the MED mark of conformity (the “Wheel Mark”) in accordance with Annex I of the Directive 2014/90/EU detailing the ABS Europe Ltd notified body identification number, 0729 and the year the mark was affixed.
Directive 2014/90/EU has introduced the provision for either two digit or four digit year reference on the mark of conformity. Both below examples are applicable.
Existing certificates issued under the current MED (96/98/EC) will remain valid until either:
Annex A.1. The current Annex A.1 details the regulations and testing standards applicable to marine equipment within the scope of the MED shall be replaced by a set of new implementation acts.
The aforementioned implementation acts are yet to be published in the official European Journal and therefore are yet to be applied. Until the new implementation acts are published (EU) 559/2015 Annex A.1 shall be applied.
Notable amendments as a result of the new implementation acts:
Authorized Representative. Directive 2014/90/EU Article 13 reinforces the previous requirement for an authorized representative. As of September 18, 2016, all manufacturers located outside of the EU are required to appoint an authorized representative to market the approved equipment.
The selection of an authorized representative is the responsibility of the manufacturer. The Authorized representative shall be a natural person or legal entity within an EU territory. As part of the module B or G application, contact details of the authorized representative shall be provided. The mandate required by Article 13 shall be reviewed as part of the production conformity phase to confirm that the written mandate meets the requirements of Directive 2014/90/EU Article 13.
The key task of the authorized representative’s appointment is to ensure the cooperation with competent national authorities based in EU. However, if an EU based manufacturer fulfils his obligations according to Article 12, then there is no need to appoint an authorized representative.
Adequate Analysis and Assessment of the risks. Directive 2014/90/EU Annex II, Part I Module B: EC Type-Examination, point 3, third indent and Part V Module G: EC Unit Verification, point 2 requires that technical documentation, which is part of the application, shall also include “an adequate analysis and assessment of the risk(s)”.
ABS Europe Ltd. interpretation of the requirement for “an adequate analysis and assessment of the risk(s)” requires an assessment of risk against the equipment’s intended use. The manufacturer shall consider whether a combination of the type, production and installation testing addresses the associated risks for the approved equipment. In addition the manufacturers shall consider whether any additional risk(s) as a result of the intended use require further mitigating measures.
Where a combination of the type, production and installation testing is considered by the manufacturer to fully address the risk(s) for the intended use of the equipment, the manufacturer may submit a declaration within the technical documentation. Where the assessment of risk(s) identifies additional risk(s), the manufacture shall provide details of the risk(s) and what measures have been taken to reduce the risk(s) to an acceptable level.
Equipment Marking - Data Tagging. Directive 2014/90/EU has introduced the provision for electronic data tagging to complement the mark of conformity. The technology required to implement this system remains under development. Further details maybe given on request.
Declaration of conformity. The requirements and obligations of the manufacturer in relation to the declarations of conformity have changed. The following now applies to the control and formatting of the DoC:
Please contact our dedicated team of engineers to discuss your MED requirements, ABS-MED@eagle.org.
Or start your approval process by completing the following form and emailing to the address above.
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