Class Guideline: Marine Equipment Directive
Class Guideline: Marine Equipment Directive
Class Guideline: Marine Equipment Directive
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and/or verification services, including the issuance of certificates and/or declarations of conformity, wholly or partly, on the
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DNV GL is not responsible for the consequences arising from any use of this document by others.
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FOREWORD
DNV GL class guidelines contain methods, technical requirements, principles and acceptance
criteria related to classed objects as referred to from the rules.
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
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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.
• 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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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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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.
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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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.
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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.
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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.
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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HISTORIC CHANGES
Historic changes
April 2016 edition
This is a new document.
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