Information for Manufacturers (MED)

The following are the information for manufacturers about the procedures for inspections, auditing and certification
for products under the European Parliament and the Council Directive 2014/90/EU on marine equipment.

General
At the request of manufacturers, the Croatian Register of Shipping the Notified Body no. 2489
(hereinafter referred to as the “Notified Body”), may conduct the conformity assessments in accordance with the requirements of the Directive 2014/90/EU on marine equipment for materials and equipment (hereinafter referred to as the “products”).
2489/yy


Upon satisfactory completion of these assessments, the manufacturers may affix the Wheel Mark to their products, issue an accompanying EC Declaration of Conformity and place their products on the market.

Conformity Assessment Procedures

STEP 1 - Products listed in Regulation (EU) 2021/1158
A manufacturer is to ascertain that its products in questions are listed in Regulation (EU) 2021/1158.

STEP 2 - Selection of Conformity Assessment Procedures
Annex of Regulation (EU) 2021/1158. List specifies the conformity assessment procedures applicable
to individual products.
The manufacturer is to choose the appropriate procedures for conformity assessment among those specified in Annex of Regulation (EU) 2021/1158. List, such as the assessment by means of inspections or auditing, or of the combination of inspections and auditing,
bearing in mind the frequency of delivery / quantity of the products manufactured, and other factors. One example is either of combination for inspection and auditing as the conformity assessment procedures for lifejackets as accepted in Annex as follows:
EC Type-Examination (module B) + Production-Quality Assurance (Module D),
EC Type-Examination (module B) + Product-Quality Assurance (Module E) and
EC Type-Examination (module B) + Product Verification (Module F)

STEP 3 - Submission of Applications
The manufacturer is to submit an application for conformity assessment for its products to the
Notified Body using CRS Application
Form.

STEP 4 - Inspections and Auditing
(1) Initial Inspections and Auditing
It is to be noted that among the conformity assessment procedures is the EC Type-Examination
(Module B) which is always required to be chosen except where the Unit Verification (Module G) is chosen. The manufacturer who has decided to choose the EC Type-Examination (Module B) is to submit an application for the EC Type-Examination (Module B) to the
Notified Body. Once the EC Type-Examination (Module B) has been completed, the manufacturer may choose either the Production-Quality Assurance (Module D), the Product-Quality Assurance (Module E), or the Product Verification (Module F), (in accordance with
permitted modules in the A.1 List), based on its quality system and the level of implementation, and submit the application for the procedures chosen. If the manufacturer has chosen the Unit Verification (Module G), no further procedures other than this need
to be chosen additionally.
(2) Periodical Inspections and Surveillance Auditing
EC Type-Examination (Module B)
An EC Type-Examination Certificate has a validity of four years.
At the request of the manufacturer, the Certificate may be renewed for another 4 years after conducting tests and examinations as necessary.
Production-Quality Assurance (module D) and Product-Quality Assurance (Module E)
Periodical surveillance is to be carried out to ascertain that the quality management system
implemented by the manufacturer is maintained.
If the manufacturer has its quality management system certified by and registered with the Society with the applicable standard of ISO 9001 and with the audit scope covering the products concerned, it may be having an advantage when applying for the Production-Quality
Assurance (Module D) or the Product-Quality Assurance (Module E) , as it can demonstrate that it has an effective certified quality system.
These audits are conducted concurrently with the annual audits and renewal audits under ISO 9001.

STEP 5 - Completion of the Conformity Assessment Procedures
After satisfactory completion of the inspections and auditing, the Notified Body is to issue
the following certificates:
EC Type Examination Certificate after
completion of the EC type-examination
EC Certificate of Conformity after completion of the Production-Quality
Assurance (Module D), Product-Quality Assurance (Module E), Product Verification (Module F) or Unit Verification (Module G).

STEP 6 - Affixing of Wheel Mark and Issue of Declaration of Conformity
After satisfactory completion of the inspections and auditing, the manufacturer can issue the
following certificates/statements:
Declaration of Conformity after
completion either of the Production-Quality Assurance (Module D), Product-Quality Assurance (Module E), Product Verification (Module F) or Unit Verification (Module G)

Any Inquiries

For further information and/or for any inquiries including the procedures for inspections, auditing
and certification, please contact:


Croatian Register of Shipping
Marasovica 67
21000 Split
REPUBLIC OF CROATIA
Person in charge:
Marinko Popović
Phone: +385 (0) 21 408 190
Facsimile: +385 (0) 21 358 159
e-mail: marinko.popovic@crs.hr

Certification of materials and components