MED about Safety: the Marine Equipment Directive

Council Directive 96/98/EC of 20 December 1996 on Marine Equipment amended by:

• Commission Directives
• 98/85/EC of 11 November 1998 (Annex A)
• 2001/53/EC of 10 July 2001 (Annex A)
• 2002/75/EC of 2 September 2002 (Annex A)
• Directive 2002/84/EC of the European Parliament (EP) and of the Council (Coun.) of 5 November 2002 (Art.2, 17 & 18) on the same day:
• Regulation 2099/2002 of the EP+Coun. established the COSS (Committee on Safe Seas and the Prevention of Pollution from Ships)

The Marine Equipment Directive (MED) covers certain statutory equipment carried and used on ships registered under the flags of the Member States of the European Union (including Norway and Iceland) and which are required to meet certain IMO Conventions.

The Directive includes:

• Main body: Preamble and Articles
• 5 Annexes
• Annex A.1; Equipment for which detailed testing standards exists; To be Type Approved by a Notified Body
• Annex A.2; Equipment for which no detailed testing standards exists (application of national standards is required due to lack of detailed testing standards at international level) To be Type Approved by the Administration or by a Body on behalf of the Administration. When detailed testing standards are adopted for equipment in Annex A.2 the equipment can be transferred to Annex A.1 (Article 7)
• Annex B; Modules for Conformity Assessment (various Modules: Module B – EC Type Examination; Module D – Production Quality Assurance; Module E – Product Quality Assurance; Module F – Product Verification and Module G – Unit Verification)
• Annex C; Minimum criteria to be taken into account by Member States for the designation of Bodies
• Annex D; Mark of conformity - Wheel mark

The purpose of the directive is "…to enhance safety at sea and the prevention of marine pollution through the uniform application of relevant international instruments…" MED Article 1

The Directive intends also to ensure the free movement of the listed equipments (see Annex A of the Directive) within the European Union, the European Economic Area (EEA), Norway and Iceland.

The products and relevant reference documentation

Products (Marine equipment related to Annex A.1 of MED)

• LSA (lifeboats, launching ap).
• MPP (Oil filterin eq., sewage treatment).
• FIRE (A B Class div, non combustible materials and surface coverings).
• NAV (Radars and Radars with EPA).
• RAD (406 MHz SARSAT and MF/HF radio).

Reference documentation:

• SOLAS, MARPOL, Load Lines, ColReg Conventions: over 600 references;
• 53 IMO Assembly Res., 15 IMO MSC Res., 29 IMO MSC Circ;
• European Std’s CEN, CENELEC, ETSI; International Std’s ISO, IEC, ITU-R;
• The IMO latest references at current MED are IMO Res.A.889(21), IMO Res.MSC.98(73) and IMO MSC Circ. 1009.
  

The role of EMSA is to provide technical assistance to the European Commission. In the field of marine equipment, this assistance includes inter alia the following tasks:

• Monitoring the development of performance and testing standards (Article 7.4)
• Preparation of updates of technical annexes
• Monitoring the work of the group of Notified Bodies (MarED group)
• Manage a database of EU approved equipment (Article 12.4)
• Support the Commission in the resolution of Article 13 Procedures (The Safeguard Clause)
  

The main implementation requirements (other than the standard legal aspects) are covered by :

• Art.1: To enhance safety, to ensure free ME movement.
• Art.4: ME on board Community ships meet MED provisions.
• Art.6: No WM ME shall be prohibited (market + on board).
• Art.9: To notify NB and to audit once every two years.
• Art.12: Market Surveillance (market + on board).
• Art.13: Safeguard (failure to comply, incorrect app., Std shortcm).

Member States have the obligation to implement the MED

The role of Notified Bodies (NB)

NB are servants of the Member States for the specific purpose of conformity assessment. They act always on behalf and under the entire authority of the notifying Member States. This encompasses the following duties:

• To provide MS with complete evidence about Annex C criteria.
• To carry out the Art.10 conformity-assessment procedures. To justify decisions.
• To examine tech. doc and verify that the type has been manufactured in accordance with the tech doc.
• To perform appropriate examinations and necessary tests or to get evidence of having them performed.
• To agree with applicant the location for examinations and necessary tests.
• To hold updated technical doc. concerning the certificates issued. (Including acceptable ME design modifications along the cycle of production life).
• To assess the applicant quality system.
• To audit periodically the manufacturer.
• To pay unannounced visits to manufacturer.
• To accept reapplications when documentary evidence is provided by the applicant.
• To carry out manufacturer-product surveillance as per WM exhibits.
• To provide MS and other NB information about approvals and withdrawals.
• To undergo periodic audit by designating MS.

NB must ascertain and attest that the approved products comply with the provisions of the international instruments that apply to it along the whole cycle of life of production.

• A manufacturer is a person who is responsible for designing and manufacturing a product with a view to placing it on the Community market on his own behalf
• The Manufacturer has an obligation to ensure that a product intended to be placed on the Community market is designed and manufactured, and its conformity assessed, to the essential requirements in accordance with the provisions of the Directive (Type Approved)
• The Manufacturer may use finished products, ready-made parts or components, or may subcontract these tasks. However, he must always retain the overall control and have the necessary competence to take the responsibility for the product
• Under the General Product Safety Directive (GPSD), in addition to the basic requirement to place only safe products on the market, the producers-manufacturers must inform consumers of the risks associated with the products they supply. They must take appropriate measures to prevent such risks and be able to trace dangerous products.

In adopting the Directive, the legislator delegated to the Commission a number of implementation tasks. Some of these are subject to a committee procedure, whereby the Commission needs to consult the COSS committee on the measures concerned and obtain a favourable opinion by qualified majority before it can proceed.

Among these tasks the most important ones are a) the update of the directive annexes and b) the resolution of safeguard clauses in the cases where the Commission considers that the alleged deficiencies stem from shortcomings in the applicable standards themselves.

This notwithstanding, it is current practice for the Commission to consult the Member States informally on any important items concerning the implementation of the directive, and this is normally done by means of discussion with the COSS.

The European Commission will be launching a revision of the Marine Equipment Directive (MED) in the beginning of 2008.

The Revision will be focusing on the following 3 areas:

• Annexes (A and B)
• Notified Bodies (NB)
• Safeguard clause
• Other issues stemming from the ongoing revision of the new approach, if any.

At present any time the IMO updates the list of equipment in the above Conventions, the relevant annexes in the MED need to be updated in turn. The present system has shown inefficiency given the inevitable time lag between these two exercises. The Revision of the Directive could introduce a most effective system in order to update the Annexes.

Certain conformity assessment procedures referred in the MED require the intervention of a third party, the so-called notified bodies. These bodies are chosen by the Member States and notified to the Commission. Member States are responsible for ensuring that notified bodies have a sufficient level of competence, impartiality and integrity to perform these tasks.

Practical experience has shown that the services provided by Notified Bodies performing EC Type Examination and Conformity Assessment under the premises of the MED can be improved as well as the general quality level of certain NB. It is desirable that the Revision would include some more criteria as to ensure an increased level of quality among the NB.

The current safeguard clause mechanism has proven cumbersome and particularly lengthy. This is not efficient and may be counterproductive from the perspective of both fair procedure and safety.

While a revision of the safeguard clause mechanism is currently under examination in the revision of the New Approach, the specific mechanisms in the Marine Equipment directive will need to be adapted in order to a)resolve the above mentioned problems, b) introduce the changes resulting from the revision of the New Approach, and c) cater for the specific features of the marine equipment market.