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MED2019 DOC 6.1

MED Approved Q&A vs. 2019

Marine Equipment Expert Group

APPROVED QUESTIONS AND ANSWERS

CONCERNING THE IMPLEMENTATION OF THE

MARINE EQUIPMENT DIRECTIVE

Contents

INTRODUCTION ................................................................................................................................... 2

DECLARATION OF CONFORMITY ................................................................................................... 3

MUTUAL RECOGNITION AGREEMENT WITH US CG .................................................................. 3

WILL THE ELECTRONIC TAG BE MANDATORY? ........................................................................ 4

AMENDING MED CERTIFICATES ..................................................................................................... 5

AVAILABILITY OF CERTIFICATES .................................................................................................. 5

VALIDITY OF CERTIFICATES ........................................................................................................... 6

MARKET SURVEILLANCE UNDER MED ........................................................................................ 6

NOTIFICATION of NOTIFIED BODIES .............................................................................................. 7

CERTIFICATION OF COMPONENTS OF A SYSTEM ...................................................................... 8

Member States are requested to

consider the updates (bold italics,

marked in yellow) to these already

agreed Q&As)

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INTRODUCTION

This document gathers some questions and answers concerning the interpretation of Directive

2014/90/EU on Marine Equipment. It attempts to provide guidance to Member States,

notified bodies and economic operators.

The questions were discussed between the Commission services and the Member State

representatives competent for marine equipment and the answers provided here were

approved by the Marine Equipment Expert Group (MED EG) at the MED Expert Group

Meetings held on 16 – 17 June 2015, 24 – 25 February 2016 and 28 - 29 November 2018 in

Brussels.

The answers only represent an informal opinion but may not necessarily represent the opinion

of the European Commission. This guidance document does not constitute any formal

commitment on behalf of the Commission. Only the European Court of Justice can give an

authoritative interpretation of Community legislation.

This guidance is made available on CIRCA BC.

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DECLARATION OF CONFORMITY

How should a Declaration of Conformity (DoC) be supplied to meet the requirement to

supply this to the ship along with the equipment?

The DoC may be supplied either as a hardcopy or electronically in order to allow the DoC to be

available at all times when a product has been placed on board of an EU flagged ship as required

by Directive 2014/90/EC. For several of the same products, for example a stock of 100

lifejackets, one respective declaration of conformity will be sufficient, provided that the products

are clearly identified with a batch or serial number on the DoC.

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MUTUAL RECOGNITION AGREEMENT WITH US CG

Will the USCG mutual recognition be maintained with 2014/90/EU and will it be amended in the future? Decision No 1/2018 of the Joint Committee established by the agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment was published in the EU’s Official Journal L162 on 19.6.2019. It amends the annexes of the existing agreement and adapts it to Directive 2014/90/EU. Regular contacts between EMSA and USCG are taking place in order to look into a possible further extension of the scope of the agreement.

******** What happens to Coast Guard Type Approval when a manufacturer goes out of business?

This question stems from the USCG discussion forum for Marine Equipment.

The reply below is taken from the USCG forum webpage.

Posted by LT Amy Midgett, Friday, September 22, 2017

Submitted by the Marine Safety Center

The Coast Guard requires certain equipment used on board ships to be type approved. A list of

types of equipment and the approvals can be found on the Coast Guard’s Maritime Information

Exchange. But what happens if a manufacturer of approved equipment goes out of business?

All equipment manufactured during the validity of the type approval certificate remains

“Approved” as long as it is manufactured, installed, and operated according to the terms of the

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type approval certificate. Any maintenance and repairs to this equipment must also be

performed in accordance with the manuals and components specified as part of the type

approval. If the equipment fails to operate and parts from the original equipment manufacturer

are no longer available, then the equipment is no longer operating under its type approval and

must be replaced.

Type approval certificates are issued for five years. After five years, only the manufacturer listed

on the certificate can request renewal, unless otherwise transferred as noted below. After a

period of five years, if not renewed, the certificate will be placed in an “Expired” status. At this

point, the product is no longer approved for production, but items manufactured prior to the

expiration of the approval remain “Approved” as described above.

If another company purchases the original manufacturer and wants to retain type approval, the

company must contact the Coast Guard to request that the certificate be updated to reflect the

name and address of the new company. The certificate will be updated with a revision number,

and the previous number issued to the original manufacturer will be marked “Former-May Use.”

This allows any equipment manufactured by the original manufacturer during the period of

validity of the certificate to continue to be installed. Further, the new entity can continue to

produce the system as long as it is manufactured, installed, and operated according to the terms

of the type approval certificate. If the new entity intends to make changes to the design, then

they must do so in accordance with the requirements for changes to approved systems in 46 CFR

162.060-16.

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WILL THE ELECTRONIC TAG BE MANDATORY?

Regarding Article 11. The wording suggests that the manufacturer MAY use the

electronic tag. Is this to suggest that if the Commission highlights a piece of equipment

benefitting from the electronic tag that it is not mandatory for manufacturers to adopt

the use of the tag?

Making the use of the Electronic Tag mandatory would require a new co-decision proposal

with full involvement of the Council and the European Parliament, since Directive

2014/90/EU does not grant the Commission implementing powers in this regard.

Even though the study foreseen in Article 11.2 has demonstrated the cost effectiveness of the

measure, the Electronic Tag will remain a voluntary measure for the time being.

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AMENDING MED CERTIFICATES

How to amend clerical mistakes on EC Type Examination Certificates?

What happens if a product for which an EC Type Examination Certificate has been issued

only changes its name while maintaining identical product characteristics?

It has been reported that in some cases EC Type Examination Certificates may contain clerical

mistakes.

In such cases these mistakes should be promptly addressed by the NB by re-issuing a formally

correct certificate.

It has also been reported that manufacturers of MED products sometimes change product names

for commercial or other reasons.

In such cases and under the condition that the product remains unchanged, the NB may re-issue

the certificate of conformity with the new name; in addition when re-issuing a certificate due to

a changed product name, an explanation and the old product name(s) should be provided.

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AVAILABILITY OF CERTIFICATES

Is there a requirement for Notified Bodies and Manufacturers to supply the Commission

copies of Certificates issued and Declarations of Conformity to be kept as per Article 35(4) a

and b?

There is no legal requirement to do so.,and there is currently no system for storing this

information However, some MS noted that there is a strong incentive to supply such

documents since Notified Bodies and Manufacturers would want proof of the conformity of the

respective products to be available to Flag Administrations and Market Surveillance Authorities.

This issue will be further investigated during the development of the Cost/Benefit analysis

on the introduction of an electronic tag for marine equipment under the Directive. The

Certificates can be centrally stored in the new MED database and will be linked to the product

through the future electronic tagging system.

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VALIDITY OF CERTIFICATES

Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on

Marine Equipment and repealing Council Directive 96/98/EC takes effect on the 18

September 2016 and the Council Directive 96/98/EC of 20 December 1996 on marine

equipment has been repealed. Have existing certificates issued by Notified Bodies under the

Marine Equipment Directive (96/98/EC) become invalid on 18 September 2016 irrespective

of changes to performance and testing standard requirements for marine equipment within

the scope of the Marine Equipment Directive?

No, existing certificates issued under the Marine Equipment Directive 96/98/EC will remain

valid until either:

They reach their expiry date (according to MarED Approved Recommendation GEN 006,

5 years for a Module B certificate);

The conditions of the certificate’s validity are breached;

or

Marine equipment meeting the specified standards within the existing certification is no

longer accepted for being placed on board an EU ship in accordance with the

Commission Regulations pertinent to Article 35(2) and (5) of Directive 2014/90/EU.

MARKET SURVEILLANCE UNDER MED

Are the market surveillance authorities within the MED coordinated by your branch of the

Commission? Which is the official channel for communicating market surveillance activities

in this area?

The EU market surveillance framework is based chapter III of Regulation (EC) No 765/2008

setting out the requirements for accreditation and market surveillance relating to the marketing

of products.

According its Article 24.1, Member States shall ensure efficient cooperation and exchange of

information between their market surveillance authorities and those of the other Member States

and between their own authorities and the Commission and the relevant Community agencies

regarding their market surveillance programmes and all issues relating to products presenting

risks.

The New Marine Equipment Directive furthermore obliges the Commission to provide for the

organisation of exchanges of experience as regards market surveillance. The Commission

services therefore have set up a so-called ADCO (Administrative Co-operation on Market

Surveillance) group for market surveillance in 2015.

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In case that a non-compliant product has been identified, Member States are advised to

communicate this directly to the other Member States and the responsible Commission

services through ICSMS (https://webgate.ec.europa.eu/icsms/).

When a Member State has taken measures, in line with Article 22 of Regulation (EC) No

765/2008, it should also notify serious non-compliances of products through the Commissions

rapid alert system (RAPEX). A list of national contact points for RAPEX can be found on:

https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/cont

ent/pages/rapex/docs/rapex_appointed_authorities_en.pdf

The competent authorities for marine equipment in the Member States should also inform their

national market surveillance authorities about any planned market surveillance activities in

relation to marine equipment, so that these can be included in the market surveillance

programmes established in accordance with Article 18.5 of Regulation (EC) No 765/2008.

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NOTIFICATION of NOTIFIED BODIES

In the process of implementing Directive 2014/90/EU on Marine Equipment into national law a

seemingly discrepancy in the Directive has been identified by a MS: this leads to the question

whether accreditation of conformity assessment bodies to be notified is mandatory or not under the

Directive.

There are two indications in the Directive that accreditation is not mandatory:

Firstly, Article 18(3) of the directive states that ‘Member states may decide that the assessment and

monitoring referred to in paragraph 1 (assessment and monitoring of Notified bodies) are to be

carried out by a national accreditation body’. Secondly point 2.5 of annex IV to the Directive states

that ‘……within two weeks of a notification where an accreditation certificate is used or within two

months of a notifications where accreditation is not used’, giving a clear indication that there is

choice between accreditation and other means of providing proof that the conformity assessment

body meets the requirements listed in annex III.

However, there is also an indication that accreditation is mandatory: point 18 of annex III to the

Directive states that Conformity Assessment bodies shall meet the requirements of standard EN

ISO/IEC 17065:2012. According to the guidance papers on accreditation (DG Growth, version July

2014) only national accreditation bodies are allowed to give an attestation that a conformity

assessment body meets the requirements of a harmonized accreditation standard, such as ISO

17065:2012. Therefore we interpret point 18 of annex III as an obligation for candidate notified

bodies to be accredited against ISO 17065:2012. This leaves no room for Conformity Assessment

bodies to be notified without accreditation. This seems to be in contradiction with the two

possibilities for notified bodies to prove that they meet the requirements of annex III. Especially

because the requirements in annex III are also covered by the requirements in ISO 17065:2012. This

is made transparent in this guidance document for national accreditation bodies:

http://www.european-accreditation.org/publication/ea-2-17-rev02-december-2014

In this particular case precedence should be given to the provisions contained in Article 18. This

interpretation allows for an assessment by the notifying authority that the body in question

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meets the requirements of standard EN ISO/IEC 17065:2012 without involving the national

accreditation agency.

This means that ALL bodies notified for Directive 2014/90/EU will be required to either:

be accredited according to EN ISO/IEC 17065:2012

OR

demonstrate by other means to the notifying authority of the relevant Member State that

they comply with the requirements of ISO/IEC 17065:2012.

The notifying authority may decide whether it will only allow accreditation or if it wants to

verify compliance with the requirements of EN ISO/IEC 17065:2012 itself.

In addition, testing laboratories used by conformity assessment bodies for conformity

assessment purposes have to meet the requirements of EN ISO/IEC 17025:2005. It can be

assumed that laboratories which have been inspected in the framework of an OECD good

laboratory practice (GLP) monitoring programme and which are in compliance with the

principles of GLP also fulfil these requirements.

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CERTIFICATION OF COMPONENTS OF A SYSTEM

How should component equipment be certified regarding its compatibility with other

equipment?

This question is raised in relation to the certification of components of a system (or for systems

of systems) that are presumed to be compatible only in relation to a specific system.

A simple example could be a lifejacket light that may only be compatible with certain lifejackets.

How should this be taken into account on the type examination certificate issued by the Notified

body and / or the Declaration of Conformity issued by the Manufacturer?

Additionally which Declaration of Conformity should be supplied to a ship in this example, the

DoC for the lifejacket or for the lifejacket and the lifejacket light?

Answer (see also p. 16 of the The ‘Blue Guide’ on the implementation of EU product rules (Commission Notice 2016/C 272/01)):

“A combination of products and parts, which each comply with applicable legislation, does not always constitute a finished product that has to comply itself as a whole with a given Union harmonisation legislation. However, in some cases, a combination of different products and parts designed or put together by the same person is considered as one finished product which has to comply with the legislation as such. In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it

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complies with the provisions of the laws concerned, and for fulfilling all the requirements of the legislation in relation to the assembly, the EU declaration of conformity and [CE marking]1. The fact that components or parts are [CE2 marked] does not automatically guarantee that the finished product also complies. Manufacturers must choose components and parts in such a way that the finished product itself complies. ”

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Is there a need for a Notified Body to repeat the conformity assessment for already wheel

marked components?

A component of a system is produced by a company A which holds a module B and D issued

by the NB X.

When this component is integrated into a system (which also falls under the MED) by a

company B and it is certified by NB Y, is there the need for the NB Y to re-audit the module

D of the company A?

If there is a relevant and valid certificate by another NB (NB X) on a component of a

system like in this case, NB Y, which takes responsibility for the conformity assessment

it performs to the full system, should accept the certificates for the component issued by

NB X.

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1 Read : wheelmarking 2 Read : wheelmarked