Services for export in the EU

 

> WE offer, since 2014,

an advanced and complete range of services for the foreign companies that want to export products and services in the European market.

 

> WE help and supports 

the customers to manage all the obligations the European law and regulations provide for marking of conformity, appointment of Authorised Representative, meet the European and international standards and fulfill the requests of national and European authorities.

 

> We also assists 

the customers for custom compliance, risks analysis/assessment/management, technical support, translation, accreditation and representation before the European bodies, classification, labelling and packaging.

 

  INTRODUCTION on the figure of the  EC REP

According to the EU laws, a manufacturer that is not established within the European Union must be appoint a representative, a person other than the importer or the distributor, who will represent the manufacturer in the whole European Union (whereas may have many distributors and/or sales agents in the EU).

The duties of the EU Authorised Representative are firstly those of being a point of contact for the European and national authorities responsible for market surveillance and product safety, that may contact at any time the Authorized Representative for information about the products.

Manufacturers are obliged in ensuring that their products, placed on the extended Single Market of the EEA (27 European Union Member States + Iceland, Liechtenstein and Norway) meet European safety, health, and environmental protection requirements.

It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the European market.

The EU regulations set a list of products for which, due to the higher safety risks, safety cannot be checked by the manufacturer alone and must be performed by an independent organisation, a notified body appointed by national authorities.

Under the EU decision N. 768/2008/EC on a common framework for the marketing of products, the Authorized Representative shall perform the tasks specified in the mandate received from the manufacturer. The “new approach” directives have an explicit obligation of the written form for the appointment of the Authorized Representative by the manufacturer.

 

 The mandate shall allow the authorized representative to do at least the following tasks:

a) keep available for the national supervisory authority the EC declaration of conformity and the technical documentation for a period of ten years following the placing on the market of the product;

b) following a reasoned request from a competent national authority, provide all information and documentation necessary to demonstrate the conformity of a product;

c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate. 

 The figure of the "authorized representative" can in no way be confused with other figures belonging to the trade chain, such as "importers" and "distributors".

 

 

> Our experts provide fast and efficient  service as Authorised Representative  ( EC REP  ) in accordance with the Marine Equipment Directive 2014/90/EU for your Marine equipment used on board ships:

 

•             Life-saving appliances (SOLAS III)

•             Marine pollution prevention equipment (MARPOL)

•             Fire protection equipment (SOLAS II-2)

•             Navigation equipment (SOLAS V)

•             Radio-communication equipment (SOLAS IV)

•             COLREG 72 – equipment

•             SOLAS II-1 – equipment

 

 

> If you wish, we also help you in your  MED certification process,  also known as the “wheelmark”,  with advice on the assessment procedures (modules) relevant for your product.

Then we safely guide you through the certification process. This includes your completed MED form and all the other necessary documents as well as testing by a recognised laboratory or with the presence of a  our surveyor.  For Module D or E, a quality audit needs to be performed at your production site. Your MED certificate is immediately issued after completion of the process. 

 

 

Services for export in the EU

  

     > We  works together with clients to achieve the success of their business, with optimum efficiency and reasonable price.  

 > We provides a full service for Consulting for International standard : (ISO, CE Mark, etc) 

 > We help customers and their importers and distributors, on the Italian territory, to solve any problem, relating to Industrial Property rights, sof goods in transit in the Italian ports.


 > We interact with Italian and European customs.


 > We are certified consultants by the UIBM - Italian Patent and Trademark Office and by the EUIPO- European Union Intellectual Property Office.  www.italypatent.it

 

DEVICES

  

 

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devices listdevices list [960 Kb]

DB MARINE EQUIPMENT (MED)

 

 

 

 

 

The data of MED certificates of our customers,   are published on the our DB.

 

Section under construction

Obtaining the Certificate

 To be able to bring the MED equipment/products into the EU market a valid EC Certification of the following Module combinations is necessary:

B+D or B+E or B+F or G

 

▪ Module B: EC Type examination of the product design
▪ Module D: Assessment of the quality system for production to ensure that the products will be produced conform to type as described in Module B
▪ Module E: Assessment of the quality system for the product to ensure that the products will be produced conform to type as described in Module B
▪ Module F: Verification of single products or statistical verification of homogeneous lots to ensure the conformity with the type as described in the Module B
▪ Module G: Assessment of the design and testing of a single product, to ensure the conformity with the requirements
The Implementing Regulation shows the allowable module combinations for each MED item.

The Module B certificate (Type EC Assessment of product), the Module D certificate (Quality Assessment of production) and the Module E certificate (Quality Assessment of product) are valid until their expiry date, unless otherwise indicated by later Implementing Regulations issued after the EC certificate.
There is no time limitation for the validity of a Module F certificate (Assessment of Product series) and a Module G certificate (Single Unit verification).
If the product is changed or new Implementing Regulations to MED introduces changes to requirements/testing standards, a Re-Assessment by a notified body is necessary.  

 

The 3rd Implementing Regulation (EU) 2019/1397 is applicable since 3rd of October 2019 and will apply until replaced by the 4th Implementing Regulation (EU) 2020/1170 (valid from 2020-09-01)

(Indicating design, construction and performance requirements and testing standards for marine equipment).

 

Implementing Regulation (EU) 2018/773 Applicable from 2018-06-19 

Implementing Regulation (EU) 2018/608

(Laying down technical criteria for electronic tags for marine equipment)

Implementing Regulation (EU) 2018/414

(Identifying the specific items of marine equipment which can benefit from electronic tagging)

   

SMALL and MEDIUM BOATS CERTIFICATION

 SECTION IN CONSTRUCTION