MED 2014/90/UE - Conformity assessment SCHEME
GENERAL
Text of the MED 2014/90/EU
The text of the MED is given in attached document.
EU Regulations associated to the MED 2014/90/EU
The text of the last applicable implementing regulation is available in attached documents.
Items and their applicable requirements
The products which can be subject to the conformity assessment procedure by Recognised Organisation (RO) in accordance with the MED are those listed by the last applicable implementing regulation excluding the items given in .
The applicable International Regulations, Resolutions, Circulars of IMO and Testing Standards are those listed by the last applicable implementing regulation.
Requirements other than IMO are to be applied in the version listed in the last applicable implementing regulation.
IMO requirements are to be applied in their up-to-date version which is given in circulars regularly made available by DO-EMC.
| Excluded item number | Excluded item designation |
|---|---|
MED/1.3 | Lifebuoys self-activating smoke signals |
MED/1.8 | Rocket parachute flares (pyrotechnics) |
MED/1.9 | Hand flares (pyrotechnics) |
| MED/1.10 | Buyoant smoke signals (pyrotechnics) |
| MED/1.11 | Line-throwing appliances |
| MED/3.3 | Fire-fighter’s outfit: protective clothing (close proximity) |
| MED/3.4 | Fire-fighter’s outfit: boots |
| MED/3.5 | Fire-fighter’s outfit: gloves |
| MED/3.6 | Fire-fighter’s outfit: helmet |
| MED/3.7 | Self-contained compressed air-operated breathing apparatus |
| MED/3.8 | Compressed air line breathing apparatus |
| MED/3.41 | Emergency escape breathing devices (EEBD) |
| All items MED/5.xx | Radiocommunication equipment |
| MED/7.1 | Self-contained compressed air-operated breathing apparatus for entry and work in gasfilled space |
DEFINITIONS
Manufacturer
The definition is given by MED article 2:
Manufacturer
Manufacturer means any natural or legal person who manufactures marine equipment or has marine equipment designed or manufactured, and markets that equipment under its name or trademark.
Authorised representative
The definition is given by MED article 2:
Authorised representative
Authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specific tasks.
Conformity assessment route
Definition of Modules
The conformity assessment route is made of modules related to design phase and production phase.The MED is using the following routes depending on the type of product :
Modules B + D
Modules B + E
Modules B + F
Modules G
Requirements for each module are given in MED Annex II and Recognised Organisation (RO)’s instructions about each module are given in the TTE for each module.Module B is defined as "EC Type-examination".Module D is defined as "Production Quality assurance"Module E is defined as "Product Quality assurance"Module F is defined as "Product Verification"Module G is defined as "Unit Verification"
The route allowed for each type of product (item) is given by the MED.
Selection of the Notified Body
As required by the MED article 12.2, the manufacturer is responsible to have the applicable conformity assessment procedures carried out.
As required by the MED Annex II for each module B, D, E, F or G, the Notified Body is chosen by the manufacturer.
Several Notified Bodies (NB) may be involved in the conformity assessment process :
The manufacturer may decide to chose a Notified Body NB1 to carry out the EC type-examination certification (module B) and may decide to chose a Notified Body NB2 to carry out the quality system approval (module D or E);
The manufacturer may decide to chose a Notified Body NB1 to carry out the EC type-examination certification (module B) and may decide to chose a Notified Body NB2 to carry out the product verification (module F);
Selection of the modules
As required by the MED article 12.2, the manufacturer is responsible to have the applicable conformity assessment procedures carried out.
The modules permitted for the concerned type of equipment are given by the MED.
The modules are chosen by the manufacturer among those permitted.
US - EC Mutual Recognition Agreement
General
The European Community and the United States have signed a Mutual Recognition Agreement (MRA) on February 27, 2004.
The MRA entered into force on July 1st, 2004.
The MRA allows a manufacturer to apply for an additional marking with USCG format as far as the product is covered by the MRA.
The USCG and the EU COMM have confirmed that the MRA is still in use with the new MED.
Products concerned by the MRA
The scope of products of the MRA is detailed in Annex II of Decision No. 1/2023 of the joint committee established by the agreement between the European Union and the United States of America..
The list of products with the corresponding USCG approval category is given in attached documents.
Marking of products
The provisions for marking of products are detailed in MARKING OF PRODUCT
The unique identifier used by Recognised Organisation (RO) is the EC type-examination certificate number.
Reference text
The reference text of the MRA is given in attached document.
A guidance to stakeholders issued by the USCG for the MRA is given in the document “NVIC 2-19 CH-2_Guide to Marine Equipment Approval Covered by a Mutual Recognition Agreement_28 December 2023.pdf" made available in attached document.
DOCUMENTS to be issued BY THE MANUFACTURER AND BY THE NOTIFIED BODY
Untitled
| Conformity route | Documents issued by the Manufacturer | Documents issued by the Notified body |
|---|---|---|
B + D | EU declaration of conformity to type as per MED article 16 | EC type-examination certificate� (B)Quality system approval certificate� (D) |
B + E | EU declaration of conformity to type as per MED article 16 | EC type-examination certificate (B)Quality system approval certificate (E) |
B + F | EU declaration of conformity to type as per MED article 16 | EC type-examination certificate (B)Certificate of conformity (F) |
G | EU declaration of conformity for the unit as per MED article 16 | Certificate of conformity (G) |
MARKING OF PRODUCT
Marking in compliance with the MED
Reference is made to the MED articles 9 and 10 for the requirements on marking.The format of marking is defined in MED Annex I.
In case Recognised Organisation (RO) is the Notified Body for the production surveillance module (D, E, F) or Module G, the mark shall be followed by the Recognised Organisation (RO) Marine & Offshore identification number 2690 and by the year (4 digits or last 2 digits) in which the mark is affixed.The mark shall be affixed at the end of the production phase.
Exemple of MED marking :
Such marking is corresponding to a product marked in year 2017.
Marking of product where the USCG marking is requested based on the US - EC MRA on marine equipment
Case 1:Recognised Organisation (RO) Marine & Offshore has performed the assessment for both modules B+D, B+E, B+F or for module G. In that case the marking is to be according to the following format :
USCG Approval category / EC2690 / number of EC type-examination certificate issued by Recognised Organisation (RO) Marine & Offshore where the USCG approval category is the number assigned by USCG to the type of product concernedExample of USCG marking:
165.101 / EC2690 / 9999 A.0 MED in case of a magnetic compass.
Case 2:The assessment for module B has been performed by an other Notified Body but Recognised Organisation (RO) Marine & Offshore has performed the assessment for the module D, E or F.
In such case the marking is to be according to the following format :
USCG Approval category / number of NB 1 / Unique identifier assigned by NB1 / EC2690 where the USCG approval category is the number assigned by USCG to the type of product concerned and where the unique identifier is the identifier given by the Notified Body 1 for the product concerned (refer to the Module B certificate which shall contain such information, in general it is the certificate number).Example of USCG marking :
165.101 / EC00xx / xxxx / EC2690 in case of a magnetic compass with EC type-examination certificate issued by the Notified Body EC00xx who has given the unique identifier number xxxx.
EU declaration of conformity
Untitled
As required by the MED article 12.3, where the compliance of marine equipment with the applicable requirements has been demonstrated by the conformity assessment procedures, manufacturers shall draw up an EU declaration of conformity in accordance with MED article 16.
As required by the MED article 16.4, a copy of the EU declaration of conformity covering the equipment concerned shall be provided to the ship when marine equipment is placed on board.
As required by the MED article 16.5, a copy of the EU declaration of conformity shall be provided to the Notified Body.