Stress free guide to product compliance

2021-02-24
ProductIP
Experienced

Conformity assessment modules

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Conformity assessment

The obvious objective of conformity assessment is to demonstrate that all products conform to relevant legislation.
The manufacturer always remains responsible for the execution of conformity assessment, even if design, tests, documentation or production is subcontracted.
The manufacturer also remains responsible when part of the conformity assessment is carried out by a Notified Body.

It is the manufacturer that is responsible for:

  • Taking all measures necessary to ensure compliance of the products and production;
  • Drawing up the technical documentation of the product;
  • Signing the EU Declaration of Conformity and affixing CE marking (if legislation so requires);
  • Showing the Notified Body's identification number next to CE on the product (if legislation so requires).

Modules for conformity assessment procedures

So, conformity assessment is the process carried out by the manufacturer to demonstrate product compliance.
Conformity assessment of a product is carried out during the design phase and the production phase.
There are only a limited number of procedures or "modules" available for the conformity assessment,
at the same time there are sufficient modules available to cover a wide range of product legislation.

EU Decision

All conformity assessment modules are described in Annex II of EU Decision 768/2008/EC.
Decision 768/2008/EC is part of the New Legislative Framework (NLF).
Product legislation often refers to Decision 768/2008/EC for the conformity assessment procedures; although in some cases reference is made to earlier but withdrawn Decisions 93/465/EEC or 90/683/EEC.

Most modules require the involvement of a so-called Notified Body.

Notified Bodies

A Notified Body is an independent assessment organisation that is designated by national authorities,
They assess the conformity of certain products with the essential requirements of the applicable EU legislation. Notified bodies must have appropriate facilities and qualified technical staff. Typically, Notified Bodies must be accredited and they under surveillance of national authorities.
Manufacturers are free to choose any notified body to carry out the conformity assessment procedure.

All Notified Bodies for each applicable product legislation can be found in the NANDO information system.

There are 4 (actually 3) possible involvements by Notified Bodies:
No Notified Body involvement at all: module A;
Involvement, but only in the production phase: modules A1, A2;
Involvement in the design phase: module B followed by production phase: modules C1, C2, D, E, F;
Involvement in design and production phases: modules D1, E1, F1, G1, H, H1.

Directives, regulations and modules

The applicable directive or regulation describes the modules that are allowed for conformity assessment.
The table below lists the possible conformity assessment modules for certain common product legislation.

PRODUCT LEGISLATION

MODULES

Outdoor noise directive 2000/14/EC

Module A   (only if not subject to sound level limits), else:  

Modules A2 or G or H   (subject to sound level limits).

Toys safety directive 2009/48/EC

Module A   (with harmonised standards), else: 

Module B+C.

RoHS directive 2011/65/EU

Module A only.

EMC directive 2014/30/EU

Module A; or

Module B+C.  (voluntary alternative).

Non-automatic weighing instruments 2014/31/EU

Modules B+D or B+F, Modules D1 or F1 or Module G.

Low Voltage directive 2014/35/EU

Module A only.

Radio equipment directive 2014/53/EU

Module A  (with harmonised standards), else: 

Module B+C or Module H.

Personal protective equipment (EU) 2016/425

Module A   for PPE category I only; 

Module B+C   for PPE category II only; 

Modules B+C2 or B+D   for PPE category III only.

Gas appliances regulation (EU) 2016/426

Modules B+C2 or B+D or B+E or B+F; or 

Module G    only for single units / small quantities.

Medical devices regulation (EU) 2017/745

Module A   (Only for Class I devices), else: 

Consult a Notified Body (for Classes Ia, IIa, IIb and III).

Other common product legislation but with specific assessment procedures

The following directives and regulations are not (yet) based on the common conformity assessment procedures.
For some products specific deviations from the existing modules were deemed necessary.

  • Food-contact materials regulation (EC) 1935/2004;
  • Machinery directive 2006/42/EC;
  • Chemical regulation REACH (EC) 1907/2006;
  • Cosmetics regulation (EC) 1223/2009;
  • Ecodesign directive 2009/125/EC;
  • Construction products regulation (EU) 305/2011;
  • Measuring instruments directive 2014/32/EU.

The modules

For an extensive description of the modules one needs to study the applicable product legislation.
A short description of the modules is given below; this is a summary from the Blue Guide.

Module A: Internal production control
This is the only procedure that does not require involvement of a Notified Body.
This procedure is also known as "first party attestation" or "self declaration", the assessment is done "internally".
The Manufacturer himself takes care of all required tests, technical documentation and ensures the conformity of the product and the production process against the relevant requirements, there is no third-party involvement.

Module A1: Module A plus supervised product testing
The Manufacturer himself ensures the conformity of the products to the requirements.
Additionally tests on specific aspects of the product are carried out by - or under supervision of - a Notified Body.

Module A2: Module A plus supervised product checks at random intervals
The Manufacturer himself ensures the conformity of the products to the requirements.
Additionally product checks at random intervals are carried out by - or under supervision of - a Notified Body.

For all of the following modules the involvement of a Notified Body is compulsory.
There are ONE-module and TWO-module procedures.

TWO-MODULE PROCEDURES - PROCEDURES BASED ON EU-TYPE EXAMINATION

In some cases the conformity assessment procedure is in two steps:
First examination of the conformity of a sample or the design of the product: EU-Type examination (module B);
Then, determination of the conformity of the manufactured products (production) against the approved sample.

In these cases conformity assessment procedures are composed of two modules; the first module is always module B.
And then Module B is followed by module C1, C2, D, E or F.
It is allowed to involve two Notified Bodies, one for the first module and another one for the second module.

Module B: EU-type examination
EU type-examination is the procedure whereby the Notified Body ascertains and certifies that the technical design of a product (representative sample), including its technical documentation, complies with a directive / regulation.

Module C: Conformity to EU-type based on internal production control
The Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved product under module B.

Module C1: Module C plus supervised product testing
The Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved product under module B.
The Notified Body tests the product on specific aspects.

Module C2: Module C plus supervised product checks at random intervals
The Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved product under module B.
The Notified Body tests the product on specific aspects at random intervals.

Module D: Conformity to EU-type based on quality assurance of the production process
The Manufacturer operates a production quality assurance system (manufacturing and inspection of final product) in order to ensure conformity to EU-type.
The Notified Body assesses the quality system.

Module E: Conformity to EU-type based on product quality assurance
The Manufacturer operates a product quality assurance system (final product inspection only) and testing in order to ensure conformity to EU-type.
The Notified Body assesses the quality system.
Module E is thus similar to module D without the provisions relating to the manufacturing process.

Module F: Conformity to EU-type based on product verification
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 module C2 but the Notified Body carries out more systematic product checks.

ONE-MODULE PROCEDURES - ONE PROCEDURE FOR BOTH PHASES (DESIGN AND PRODUCTION)

Module D1: Quality assurance of the production process
Similar to module D but without module B, no EU-type examination.
The Manufacturer operates a production quality assurance system (manufacturing and inspection of final product) in order to ensure conformity to the requirements.
The Notified Body assesses the production quality system.

Module E1: Quality assurance of final product inspection and testing
Similar to module E but without module B, no EU-type examination.
The Manufacturer operates a product quality assurance system (final product inspection only) and testing in order to ensure conformity to the requirements.
The Notified Body assesses the quality system.
Module E1 is similar to module D1 without the provisions relating to the manufacturing process.

Module F1: Conformity based on product verification
Similar to module F but without module B, no EU-type examination.
The Manufacturer ensures compliance of the manufactured products to the requirements.
The Notified Body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to the requirements.
Module F1 is like A2 but the Notified Body carries out more detailed product checks.

Module G: Conformity based on unit verification
The Manufacturer ensures compliance of the manufactured products to the requirements.
The Notified Body verifies every individual product (each unit) in order to ensure conformity to requirements.

Module H: Conformity based on full quality assurance
The Manufacturer operates a full quality assurance system in order to ensure conformity to requirements.
The Notified Body assesses the quality system.

Module H1: Module H plus design examination
The Manufacturer operates a full quality assurance system in order to ensure conformity to requirements.
The Notified Body assesses the quality system and the Notified Body carries out a detailed examination of the product design product and issues an EU design examination certificate.

Conformity assessment modules image

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