copy the linklink copied!Annex B. Overview of conformity assessment modules in the EU New Legislative Framework

copy the linklink copied!

Modules

Description

A

Internal production control

Covers both design and production.

The manufacturer himself ensures the conformity of the products to the legislative requirements (no EU-type examination)

A1

Internal production control plus supervised product testing

Covers both design and production.

A + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer.

A2

Internal production control plus supervised product checks at random intervals

Covers both design and production.

A + product checks at random intervals carried out by a notified body or in-house accredited body.

B

EU-type examination

Covers design.

It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated.

A notified body examines the technical design and or the specimen of a type and verifies and attests that it meets the requirements of the legislative instrument that apply to it by issuing an EU-type examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type.

C

Conformity to EU-type based on internal production control

Covers production and follows module B.

Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.

C1

Conformity to EU-type based on internal production control plus supervised product testing

Covers production and follows module B.

Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.

C + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer.

C2

Conformity to EU-type based on internal production control plus supervised product checks at random intervals

Covers production and follows module B.

Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.

C + product checks at random intervals tests on specific aspects of the product carried out by a notified body or in-house accredited body.

D

Conformity to EU-type based on quality assurance of the production process

Covers production and follows module B.

The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EU-type. The notified body assesses the quality system.

D1

Quality assurance of the production process

Covers both design and production.

The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to legislative requirements (no EU-type, used like D without module B). The notified body assesses the production (manufacturing part and inspection of final product) quality system.

E

Conformity to EU-type based on product quality assurance

Covers production and follows module B.

The manufacturer operates a product quality (=' production' quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system.

The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D (and D1 too) aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process.

E1

Quality assurance of final product inspection and testing

Covers both design and production.

The manufacturer operates a product quality (=' production' quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to the legislative requirements (no module B (EU-type), used like E without module B). The notified body assesses the quality system.

The idea behind module E1 is similar to the one under module D1: both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final product, while the quality system under module D1 aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E1 is thus similar to module D1 without the provisions relating to the manufacturing process.

F

Conformity to EU-type based on product verification

Covers production and follows module B.

The manufacturer ensures compliance of the manufactured products to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to EU-type.

Module F is like C2 but the notified body carries out more systematic product checks.

F1

Conformity based on product verification

Covers both design and production.

The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to the legislative requirements (no EU-type, used like F without module B)

Module F1 is like A2 but the notified body carries out more detailed product checks.

G

Conformity based on unit verification

Covers both design and production.

The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type).

H

Conformity based on full quality assurance

Covers both design and production.

The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system.

H1

Conformity based on full quality assurance plus design examination

Covers both design and production.

The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system and the product design and issues an EU design examination certificate.

Module H1 in comparison to module H provides in addition that the notified body carries out a more detailed examination of the product design.

The EU-design examination certificate must not be confused with the EU-type examination certificate of module B that attests the conformity of a specimen 'representative of the production envisaged', so that the conformity of the products may be checked against this specimen. Under EU design examination certificate of module H1, there is no such specimen. EU design examination certificate attests that the conformity of the design of the product has been checked and certified by a notified body.

Metadata, Legal and Rights

This document, as well as any data and map included herein, are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area. Extracts from publications may be subject to additional disclaimers, which are set out in the complete version of the publication, available at the link provided.

https://doi.org/10.1787/4e919492-en

© OECD 2020

The use of this work, whether digital or print, is governed by the Terms and Conditions to be found at http://www.oecd.org/termsandconditions.