Class Guideline: Marine Equipment Directive

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The key takeaways are that the document outlines DNV GL's procedures for certification according to the Marine Equipment Directive and describes how certificates can be maintained, suspended or cancelled. It also describes the use of DNV GL and MED marks.

The purpose of the document is to describe DNV GL's certification procedures and conditions for certification according to the Marine Equipment Directive.

The main changes in the September 2016 edition were: 1) Directive 96/98/EC was replaced by 2014/90/EU and 2) recall was added as a new section.

CLASS GUIDELINE

DNVGL-CG-0214 Edition September 2016

Marine equipment directive

The content of this service document is the subject of intellectual property rights reserved by DNV GL AS ("DNV GL"). The user
accepts that it is prohibited by anyone else but DNV GL and/or its licensees to offer and/or perform classification, certification
and/or verification services, including the issuance of certificates and/or declarations of conformity, wholly or partly, on the
basis of and/or pursuant to this document whether free of charge or chargeable, without DNV GL's prior written consent.
DNV GL is not responsible for the consequences arising from any use of this document by others.

The electronic pdf version of this document, available free of charge


from http://www.dnvgl.com, is the officially binding version.

DNV GL AS
FOREWORD

DNV GL class guidelines contain methods, technical requirements, principles and acceptance
criteria related to classed objects as referred to from the rules.

© DNV GL AS September 2016

Any comments may be sent by e-mail to [email protected]

If any person suffers loss or damage which is proved to have been caused by any negligent act or omission of DNV GL, then DNV GL shall
pay compensation to such person for his proved direct loss or damage. However, the compensation shall not exceed an amount equal to ten
times the fee charged for the service in question, provided that the maximum compensation shall never exceed USD 2 million.

In this provision "DNV GL" shall mean DNV GL AS, its direct and indirect owners as well as all its affiliates, subsidiaries, directors, officers,
employees, agents and any other acting on behalf of DNV GL.
CHANGES – CURRENT

Changes - current
This document supersedes the April 2016 edition.
Changes in this document are highlighted in red colour. However, if the changes involve a whole chapter,
section or sub-section, normally only the title will be in red colour.

Main changes September 2016

• General
— Sec.1 [1]: Directive 96/98/EC replaced by 2014/90/EU
— Sec.1 [9]: Recall added

Editorial corrections
In addition to the above stated changes, editorial corrections may have been made.

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Marine equipment directive

DNV GL AS
CONTENTS

Contents
Changes – current.................................................................................................. 3

Section 1 General.................................................................................................... 5
1 Service description.............................................................................. 5
2 General conditions............................................................................... 5
3 Public administrative law.................................................................... 5
4 DNV GL certification procedures.......................................................... 5
5 Refusal of certification........................................................................ 5
6 Maintaining the certificate................................................................... 6
7 Changes in standards.......................................................................... 6
8 Changes by the manufacturer..............................................................6
9 Suspension, withdrawal, restriction or recall of the certificate............ 6
10 Cancelling of the certificate from the manufacturer...........................7
11 Complaints and appeals..................................................................... 7
12 Use of the certificate and certification mark (the DNV GL logo)......... 8
13 Use of the mark of conformity (wheelmark)......................................8
14 Publishing of certificates................................................................... 8

Historic changes..................................................................................................... 9

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Marine equipment directive

DNV GL AS
SECTION 1 GENERAL

Section 1
1 Service description
This document describes the DNV GL conditions and certification processes for certification to the Marine
Equipment Directive 2014/90/EU (MED). The document defines customer and DNV GL obligations additional
to the MED, the terms and conditions, the certification agreement between the parties and in the annex to
the certificate.

2 General conditions
DNV GL will, according to its Notifications, carry out the following conformity assessment procedure described
in the MED:
— Module B, EC-type examination
— Module D, production quality assurance
— Module E, product quality assurance
— Module F, product verification
— Module G, unit verification
If the requirements in MED do not provide sufficient guidance for the assessment of conformity, DNV GL
will use the recommendations from the MED Co-ordination Group for the Notified Bodies (MarED) which are
commonly accepted by the Notified Bodies.
DNV GL will not provide any consultancy services aiming to facilitate the certification.
All product information needed for the DNV GL evaluation of the product is treated as confidential.

3 Public administrative law


DNV GL’s exercise of the role as Notified Body may be subject to public administrative law requirements
insofar following from background law and/or set out in the authorization letter from the relevant Public
Authority.

4 DNV GL certification procedures


A manufacturer wishing a Notified Body service should submit an application to DNV GL. The DNV GL
application form, available on DNV GL MED website, should be used in this connection. If requested by the
customer, the notified body provides general information on the fees charged and will prepare a quotation.
The manufacturer agrees to promptly supply to DNV GL, where duly justified, any relevant information
data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen
procedure.
The manufacturer will further ensure that DNV GL, other acting on behalf of DNV GL and observers (e.g.
accreditation/notification auditors) will get all necessary work and access permits.
When all assessment activities according to the MED are completed and found satisfactory, the project is
ready for Certificate issuance. DNV GL will issue all formal documents and certificates according to the MED.

5 Refusal of certification
Certification shall be refused if the product or the quality system is found not to comply with MED.
DNV GL shall communicate refusal of certification to the applicant in writing. Information regarding the
appeal procedures shall be given.

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Marine equipment directive

DNV GL AS
Section 1
6 Maintaining the certificate
The manufacturer is responsible, at all times, to ensure that the products and systems at all times meet the
relevant requirements set out in the Directive and to undergo all DNV GL assessment activities and visits.
The assessment of conformity carried out by DNV GL does not release or otherwise discharge customer from
the sole responsibility for the compliance of the product and systems with these requirements. Corrective
actions to identified findings must be implemented within the set time limit.
The manufacturer shall authorize DNV GL to pay unannounced visits to the manufacturer’s premises when
foreseen by the directive or when DNV GL in its sole discretion finds that there is doubt regarding the
compliance of the product or the appropriate function of the approved quality system.
The fees as stipulated in the agreement between customer and DNV GL) must be paid following the
conditions for payment stated therein.
The manufacturer is also obliged to keep a record of all complaints concerning the products under the
certification scope. DNV GL will verify that the manufacturer has taken relevant corrective actions for these
complaints in conjunction with the surveillance visits for modules D and E.
DNV GL must be informed of any sub-suppliers for main parts of the product to be certified.
DNV GL reserves the right to report the following items of information to the designating / notifying
authority:
— any refusal, restriction, suspension or withdrawal of certificates
— any circumstances affecting the scope of and conditions for notification
— any request for information on conformity assessment activities performed which DNV GL has received
from market surveillance authorities
— on request, conformity assessment activities performed within the scope of their notification and, any
other activity performed, including, cross-border activities and subcontracting.
— Any third party complaints regarding the products or the certification
DNV GL reserves the right to disclose information about products or certification status to the relevant
market surveillance authorities.

7 Changes in standards
DNV GL will assess the products subject to certification to the valid versions of the standards under the
certification scope. The manufacturer is therefore always obliged to keep itself informed about the up-to-
dated standards/MED amendment and inform DNV GL, if modifications to the equipment/production are
necessary. DNV GL does not undertake an obligation to inform the manufacturer of any changes to the
applicable requirements.

8 Changes by the manufacturer


Manufacturer must report all changes with regard to design and/or production (hereunder changes in the
organization, ownership, new products, modifications to the production method and quality system, site
locations, etc.), which may reasonably be considered to have an effect of the certified product(s), to DNV
GL within a reasonable time and preferably before execution of such change. Failure to do so may result in a
non-compliance being raised by DNV GL.
It will be the decision of DNV GL whether or not a further inspection visit or audit is necessary at the time of
the announcement of any such changes.

9 Suspension, withdrawal, restriction or recall of the certificate


DNV GL may decide to suspend, withdraw, restriction or recall the certificate and, in such cases, the
manufacturer will be informed as soon as this is practicable.

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Marine equipment directive

DNV GL AS
Information regarding the applicable appeal procedure will be provided on request, including any applicable

Section 1
public administrative law procedures.
Reasons for suspension/withdrawal/restriction/recall:
— Termination of the agreement between customer and DNV GL, if required by the applicable scheme.
— The certificate, mark of conformity, or certification mark is being misused
— The requirements as set out in the MED were not fulfilled
— The product is changed and the manufacturer has not informed DNV GL about it
— The requirements for the quality system or product are no longer fulfilled
— The product is no longer covered by the Directive
— The product is no longer in compliance with the Directive, and the shortcomings observed are
not corrected by the manufacturer within an appropriate time period as defined by DNV GL under
consideration of the severity and potential impacts of these shortcomings.
— substantial defects of the equipment have come to light during operation
— Violation of the terms of the signed SFA, including non-payment of fees or refusal of access to
unexpected/periodic/planned assessments.
— Scheduled assessments not completed.
— Periodical surveillance audits not performed (Module D and E only)
— Customer voluntarily requesting temporary suspension.
Suspension of a certificate is normally initiated as the first step, followed by a withdrawal/recall if the issue
of concern is not resolved within due time. However, dependent on the seriousness of the situation, DNV GL
may decide a direct withdrawal/recall of the certificate.
DNV GL shall inform the customer about the decision on suspension/withdrawal/recall and that no products
are allowed to be put on the marked in the suspension period.
The manufacturer must delete any reference to a non-valid MED certificate in public documentation like
marketing material, websites, advertising etc.
DNV GL shall make relevant information regarding the certification it has withdrawn/recalled available to the
other Notified Bodies through MarED.

10 Cancelling of the certificate from the manufacturer


The manufacturer may cancel the certificate at any time provided that DNV GL receives a written
communication at least 60 days before the wished cancellation date authorizing DNV GL to invoice all
activities up to that date.

11 Complaints and appeals


All complaints are taken seriously, and DNV GL will do its utmost to perform according to what is expected.
An acknowledgement of received complaint will be sent without delay.
The complaint shall always include as a minimum:
— Name of the person filing the complaint
— Company name (if relevant)
— Post address and/or e-mail address
— The reason for the complain
A written complaint can be sent to DNV GL either as e-mail or by letter. Complaints addressing the
performance of one of our customers will be forwarded to the customer for their considerations and
response. All complaints will be logged and a person responsible for the handling of the complaint will be
appointed. The person responsible for handling the complaint shall organize an analysis and decide if an
immediate or corrective action is needed. A written response to the complainant shall be prepared and
forwarded. The complainant shall be informed about possibility to escalate a complaint in case the response
is not satisfactory.

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Marine equipment directive

DNV GL AS
Section 1
12 Use of the certificate and certification mark (the DNV GL logo)
The DNV GL certification mark may only be used, if the complete conformity assessment (Module B+D,
B+E, B+F, G) is performed by DNV GL. The Manufacturer shall have the right to use the valid certificate
and certification marks in standard size and design as provided by DNV GL for the purposes for which such
certificates are generally intended and used, including on letters, documents and other promotional material.
The Certification Mark may be shown on Manufacturer’s public relations material, provided it is directly
related to the product which has been certified under this Agreement, and that the explanatory text is
sufficiently precise.
The Certification Mark, together with the instructions on use, will be sent to the manufacturer, on request.

13 Use of the mark of conformity (wheelmark)


The DNV GL certification mark shall not to be mixed up with the mark of conformity (wheelmark) according
to the MED! The mark of conformity shall be applied by the manufacturer according to the MED.

14 Publishing of certificates
Copies of the MED certificates, issued by DNV GL, are published on the DNV GL external website (DNV GL
Approval Finder). They are also listed on the MarED website.

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Marine equipment directive

DNV GL AS
HISTORIC CHANGES

Historic changes
April 2016 edition
This is a new document.

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Marine equipment directive

DNV GL AS
DNV GL
Driven by our purpose of safeguarding life, property and the environment, DNV GL enables
organizations to advance the safety and sustainability of their business. We provide classification and
technical assurance along with software and independent expert advisory services to the maritime,
oil and gas, and energy industries. We also provide certification services to customers across a wide
range of industries. Operating in more than 100 countries, our 16 000 professionals are dedicated to
helping our customers make the world safer, smarter and greener.

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