Contents

CE markings
C E regulations
1. Low Voltage Directive (2014/35/EU)
2. The European Pressure Equipment Directive (PED) 2014/68/EU
3. Machinery Directive (2006/42/EC).
4. The EMC Directive (2014/30/EU)
5. Electromagnetic Compatibility (EMC) Directive
6. PPE Regulation (EU) 2016/425.
7. ATEX Manufacturers Directive 2014/34/EU

CE markings
Many products require CE marking before they can be sold in the EU. CE marking indicates that a
product has been assessed by the manufacturer and deemed to meet EU safety, health and
environmental protection requirements. It is required for products manufactured anywhere in the
world that are then marketed in the EU.
Basically, CE marking involves designing a product that meets relevant standards, building the
Technical File and the Declaration of Conformity. The key is to know exactly which steps you need to
take. All you need to do is demonstrate that you have fulfilled the essential requirements of any
relevant directive.  Also, you need to meet the relevant harmonized standards, and then produce the
Declaration of Conformity and the Technical File. Finally, you can affix the CE mark on your product
and start marketing it in the EU. Follow the flowchart below and your road to CE marking will be
smooth and fast.
Step 1: Identify the applicable Directive(s)
The first step is to identify whether your product can be CE marked or not. Not all products are
required to be CE Marked, only the products that fall within the scope of at least one of the CE
Marking Directives. There are more than 20 product Directives & Regulations covering a range of
products. Such products includes (but not limited to) electrical equipment, machines, medical devices,
toys, pressure equipment, PPE, wireless devices and construction products.
Read More…

Step 2: Identify the applicable requirements of the Directive(s)

Each Directive has slightly different methods of demonstrating conformity. This usually depends on
the classification of the product and its intended use. Every Directive has a number of ‘essential
requirements’ which the product has to meet.
The best way to demonstrate that these essential requirements have been met is by meeting the
requirements of applicable ‘harmonised European Norms’ (Standard) known as hENs. Standards may
offer a presumption of conformity to the essential requirements of the applicable Legislation.
However do not forget that the use of standards usually remains voluntary. hENs can be identified by
searching the ‘official journal’ on the European Commission’s website.
Step 3: Identify an appropriate route to conformity
The CE Marking process is always a self-declaration process however you may need to involve a
third party. This is set out in the ‘system of attestation’ and will vary between Directive. Some
products (such as invasive medical devices or fire alarm systems) may, to some extent, have a
mandatory requirement for some involvement of an authorised third party.

Step 4: Assessment of the product’s conformity

When all of the requirements have been established, you need evidence that the product meets the
essential requirements of the Directive(s).
This usually involves some assessment and/or testing. It will often involve ensuring that the
requirements of the applicable harmonised standard(s), which were identified in step 2, have been
met.
Step 5: Compile the technical documentation
Technical documentation relating to the product or range of products needs to be compiled. This
information should cover every aspect relating to conformity and is likely to include details of the
design, development and manufacture of the product. Technical documentation may also be known as
the Technical File or Technical Construction File.
 Technical description.
 Drawings, circuit diagrams and photos.
 Bill of materials.
 Specification and, where applicable, Declarations of Conformity for the critical components
and materials used.
 Details of any design calculations.
 Test reports and/or assessments.
 Instructions.
 Copy of the Declaration.
Technical documentation can be made available in any format (i.e. paper or electronic) and must be
held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in
the European Economic Area (EEA).

Step 6: Make a Declaration and affix the CE Mark

When the manufacturer, importer or authorised representative is satisfied that their product conforms
to the applicable CE Marking Directives, they must complete a Declaration. Under most Directives it
is known as the EU Declaration of Conformity but other terms exist. Such as Declaration of
Incorporation for partly completed machinery and Declaration of Performance for construction
products.

When is CE marking mandatory?

CE marking is only obligatory for products for which EU specifications exist and require the
affixing of CE marking. . Some products are subject to several EU requirements at the same time.
You must make sure that your product complies with all the relevant requirements before affixing the
CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do
not exist or do not require the affixing of CE marking.

How to obtain CE marking?

As the product's manufacturer, you bear sole responsibility for declaring conformity with all
requirements. You don't need a license to affix the CE marking to your product, however, before
doing so, you must:
 ensure conformity with all relevant EU-wide requirements
 determine whether you can assess your product by yourself or if you have to involve a
notified body
 put together a technical dossier documenting conformity: find out about technical
documentation
 draft and sign an EU declaration of conformity
 Once your product bears the CE marking — if the competent national authority requests —
you must provide them with all the information and supporting documentation concerning CE
marking.

Do you need an independent assessment?

You need to check if your product has to be tested by a notified body. You can find this information
in the relevant legislation applicable to your product: check the rules by product category.
This step is not obligatory for all products.
If you need to involve a notified body, the CE marking must be accompanied by the identification
number of the notified body. The CE mark and the identification number can be affixed separately, as
long as they appear clearly linked to each other. You can use the Nando database to search for a
notified body that can certify your product.
If your product doesn't need to be verified by an independent body, then it is up to you to check
that it complies with the technical requirements. This includes estimating and documenting the
possible risks when using your product.

Do you need to pay any fees?

If you as a manufacturer carry out the conformity assessment yourself, you won't have to pay any
fees. However, if you opt to use the services of a notified body, or if the EU specifications
applicable to your product require the independent assessment by a notified body, then you must pay
the notified body for the service they provide. The cost depends on which certification procedure that
applies to your product and the complexity of the product etc.
Source : https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/
index_en.htm

Important CE Regulations
Low Voltage Directive (2014/35/EU)
The Electrical Equipment (Safety) Regulations (LVD) applies to all electrical equipment designed for
use with a voltage rating of between 50 and 1000 V AC and between 75 and 1500 V DC. Broadly, the
scope of the LVD covers consumer and capital goods designed to operate within those voltage limits,
including in particular electrical appliances, lighting equipment including ballasts, switch gear and
control gear, electric wiring, appliance couplers and cord sets, electrical installation equipment, etc.
and electrical equipment intended for incorporation into other equipment such as transformers and
motors. As per the requisite law the participation of the notified body in the conformity assessment
procedure is not required.

The European Pressure Equipment Directive (PED) 2014/68/EU

This directive came into force on 20 July 2016. The Pressure Equipment Directive (PED)
(2014/68/EU) applies to the design, manufacture and conformity assessment of stationary pressure
equipment with a maximum allowable pressure greater than 0.5 bar
Why apply the PED?
Legislation across the EEA requires that all applicable items of pressure equipment must be fully
compliant with the PED. As a result, manufacturers must revise their working practice and develop
the appropriate Technical Files for their full product range. The PED encompasses design verification,
material selection, manufacturing/fabrication practices and qualification, product testing, product
marking and user instruction compilation.

Scope of the directive :

Pressure Equipment is defined as
 Vessels
 Pressure accessories
 Safety Accessories
 Assemblies
With a pressure housing with a maximum pressure greater than 0.5bar is defined as Pressure
Equipment
Essential steps : Product Inspection & certification, Material Approval, Type Examination, Quality
System Approval, Welder Approval

Machinery Directive (2006/42/EC).

This Directive applies to all machinery and safety components. A machine is defined as “an assembly
of linked parts or components, at least one of which moves.”. There are exclusions such as military
equipment, machines which are already covered by other, more specific, directives and equipment
which falls within the scope of the Low Voltage Directive.
The essential protection requirements demand that machine manufacturers identify the hazards that
their products contain and assess the risks these hazards present to users. Any risks identified must be
reduced to as low a level as is practicable. Detailed requirements are laid out in a series of safety
standards. The administrative provisions of the Directive require manufacturers to produce a
Technical File, sign a Declaration of Conformity and label the product with certain markings.
Annex IV contains a list of about 15 types of machine which are subject to special procedures. These
must either be made fully in accordance with the provision of the standard, or be subjected to type
examination by a Notified Body.

Essential steps:
 Product Evaluation and Gap analysis visits.
 Testing as per harmonized, international, national standards, or client’s own specification.
 Technical file review
 Issuance of Certificate

The EMC Directive (2014/30/EU)

Electromagnetic Compatibility (EMC) Directive
All electric devices or installations influence each other when interconnected or close to each other,
e.g. interference between TV sets, GSM handsets, radios and nearby washing machine or electrical
power lines. The purpose of electromagnetic compatibility (EMC) is to keep all those side effects
under reasonable control. EMC designates all the existing and future techniques and technologies for
reducing disturbance and enhancing immunity.

The electromagnetic compatibility (EMC) Directive 2014/30/EUEN••• ensures that electrical and

electronic equipment does not generate, or is not affected by, electromagnetic disturbance.
The EMC Directive limits electromagnetic emissions from equipment in order to ensure that, when
used as intended, such equipment does not disturb radio and telecommunication, as well as other
equipment. The directive also governs the immunity of such equipment to interference and seeks to
ensure that this equipment is not disturbed by radio emissions, when used as intended.
The main objectives of the directives are to regulate the compatibility of equipment regarding EMC:
 equipment (apparatus and fixed installations) needs to comply with EMC requirements when
it is placed on the market and/or taken into service
 the application of good engineering practice is required for fixed installations, with the
possibility that competent authorities of EU countries may impose measures in instances of
non-compliance

This directive regulates electromagnetic interference of electrical and electronic equipment. Have
you ever heard a buzzing noise on your audio speakers when you hold a phone or electronic device
next to it? What you hear is electromagnetic interference.
‘Electromagnetic compatibility (EMC) is the ability of electrical equipment and systems to function
acceptably in their electromagnetic environment, by limiting the unintentional generation,
propagation, and reception of electromagnetic energy which may cause unwanted effects such as
electromagnetic interference (EMI) or even physical damage in operational equipment. The goal of
EMC is the correct operation of different equipment in a common electromagnetic environment. It is
also the name given to the associated branch of electrical engineering’.
The EMC Directive (2014/30/EU) aims to ensure that any electrical and electronic equipment
minimizes the emission of electromagnetic interference that may influence other equipment. The
directive also requires equipment to be able to resist the disturbance of other equipment.
In order to comply with the EMC Directive manufacturers must:
 Design the equipment to comply with the electromagnetic emission and immunity
requirements;
 document test results and calculations that provide evidence for EMC compliance;
 apply the labelling and marking requirements.
PPE Regulation (EU) 2016/425.
Personal Protective Equipment (PPE) is defined as any device intended to be worn or held for
protection from injury. In Europe, placing PPE products on the market is regulated by Regulation
(EU) 2016/425.
PPE Regulation (EU) 2016/425 has replaced the PPE Directive 89/686/EEC in April 2018, covers the
manufacturing of PPE to ensure the highest level of protection. The CE mark on PPE is an evidence
that the PPE Complies with relevant standards and are safe for use.
Our expertise in assessing Personal Protective Equipments manufacturers around world to test and
certify their products. Our experienced Certification team can assist manufacturers in choosing the
correct procedures and test methods for their products, and provide guidance on aspects of the type-
examination such as Technical File content, Labelling, and User Information.

CE Certification of Face Mask/Respirator:

Face masks typically fall into one of two categories — surgical (MDD) or respirator (PPE). Both
variants are designed to offer various levels of protection against the transmission of bacteria.
“Respirator masks” Fall under PPE Regulation. Respirator masks are divided into three categories:
FFP1, FFP2 and FFP3. Protective masks are PPE of category III according to the Regulation (EU)
2016/425. This means that the conformity assessment includes a type examination by a notified body,
resulting in a ‘EU type examination certificate’ as well as production follow-up by a notified body
(random checks or system audit). This results in CE marking with the number of the notified body
responsible for the production follow-up next to the CE marking. The manufacturer is obliged to issue
the EU Declaration of Conformity, which must accompany the PPE, together with the instructions for
use.

Applicable Standard on Face Mask:

EN 149:2001 + A1:2009: Respiratory protective devices. Filtering half masks to protect against
particles. Requirements, testing, marking.
The major tests in EN 149: 2001 + A1:2009 are:
1. Total inward Leakage
2. Penetration of filter material
3. ompatibility with skin
4. Flammability
5. Carbon dioxide content of inhalation air
6. Head Harness
7. Field of vision
8. Exhalation Valves
9. Breathing Resistance
10. Clogging

CE Certification of Fall Protection Equipment:

Equipment designed to protect user against fall from height fall under PPE regulation (EU) 2016/425.
Fall protection equipment fall under category III according to the Regulation (EU) 2016/425. This
means that the conformity assessment includes a type examination by a notified body, resulting in a
‘EU type examination certificate’ as well as production follow-up by a notified body (random checks
or system audit). This results in CE marking with the number of the notified body responsible for the
production follow-up next to the CE marking. The manufacturer is obliged to issue the EU
Declaration of Conformity, which must accompany the PPE, together with the instructions for use.
PPE Category wise Requirement:
Category Requirement Applicable Modules
Internal Production Control a process
that requires the development of a
Category I technical file which includes the Internal production control (module A)
manufacturer’s Declaration of
Conformity.
Category Requirement
EU-type examination by a Notified
Category II
Body.
EU Type Examination certificate and
ongoing assessment of compliance.
Category III Audit the manufacturing site annually to
ensure that quality management systems
are in place.
PPE Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?
uri=CELEX:32016R0425&from=EN
Applicable Modules
EU type-examination (module B) set out
in Annex V, followed by conformity to
type based on internal production control
(module C)
EU type-examination (module B) set out
in Annex V, and either of the following:
 conformity to type based on
internal production control plus
supervised product checks at
random intervals (module C2);
 conformity to type based on
quality assurance of the
production process (module D)

Products certification

ATEX Manufacturers Directive 2014/34/EU

This directive defines each of the following product groups for use in potentially explosive
atmospheres:

 Electrical and non-electrical equipment

 Electrical and non-electrical protective systems
 Electrical and non-electrical components
 Electrical and non-electrical safety devices

The directive places responsibilities on the manufacturer of these products. The main
responsibility of the manufacturer is to prevent the formation and ignition of explosive
atmospheres. This may be achieved by using one of the well-established protection concepts
(such as flameproof protection, or intrinsic safety), or by proving compliance directly against
a set of ‘essential health and safety requirements’, which are given in the directive.

Under ATEX you can put the product in the market once you have successfully achieved EU
type Examination and Quality Assessment Notification (QAN)

EU Type Examination: Type Examination requires the products to be tested as per the
requirements of the ATEX Harmonized Standards. Based on the Intended Use and
application of the product standard for testing as per EN 60079 series shall be Tested.
Certificate under EU type is normally valid for 10 years.

Quality Assessment Notification: to put the product on the market, the manufacturer must
hold valid Quality Assessment Notification (QAN), under this it basically cover the Quality
Management System to be maintained by the manufacturer as per EN 80079-34 for the Ex
products. It requires an onsite audit and an annual surveillance audit with issuance of limited
time certificate for 3 years.

ATEX For Non Electrical Products:

For Non Electrical Products which fall into Category 2 & 3 an EU type Examination is not
required.

For category 2 Non Electrical Equipment, the technical file shall be submitted to the notified
body and shall be archived/stored with Notified body for 10 years. An acknowledgment for
archive of technical file will be issued by Notified Body, under this the technical file is not
reviewed by the Notified Body.

For Category 3 Non Electrical Equipment, there is no legal requirement to submit the
technical file with the Notified Body, the manufacture can self declare the compliance and
can use the marking once the technical file is complete.

Advantages With QCS as your Certification Partner

 Pragmatic Approach to Reduce Project Timelines and Cost.

 Trust QCS which Ensures Product Compliance with Harmonized Standards and
Directives
 One Stop Service for all Needs, Certification & Testing
 Full Scope under ATEX and Localized Auditor

USEFUL LINKS

 Applicable Directive:https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?
uri=CELEX:32014L0034&from=EN
 List of Applicable Harmonised Standard:
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/
equipment-explosive-atmosphere_en
 Notified Body Notification Scope:
http://ec.europa.eu/growth/tools-databases/nando/index.cfm?
fuseaction=notification.pdf&dir_id=153101&ntf_id=270691
 ATEX Wallchart Click here to download


Products needing CE Marking

CE marking is mandatory for products covered by the scope of the New Approach Directives. Even
product(s) manufactured outside the European Economic Area (EEA) must bear the CE Mark if they
are going to be sold within the EU. CE marking applies to products ranging from electrical equipment
and toys to medical devices and more. Here is a complete list of these product categories according to:
https://www.gov.uk/guidance/ce-marking.
1. active implantable medical devices
2. appliances burning gaseous fuels
3. cableway installations designed to carry persons
4. eco-design of energy related products
5. electromagnetic compatibility
6. equipment and protective systems intended for use in potentially explosive atmospheres
7. explosives for civil uses
8. hot-water boilers
9. household refrigerators and freezers
10. in vitro diagnostic medical devices
11. lifts
12. low voltage
13. machinery
 14. measuring instruments
15. medical devices
16. noise emission in the environment
17. non-automatic weighing instruments
18. personal protective equipment
19. pressure equipment
20. pyrotechnics
21. radio and telecommunications terminal equipment
22. recreational craft
23. safety of toys
24. simple pressure vessels

Notified Body Status

We have the product expertise and full capability to test to a variety of directives, in alliance with
Euro-tech assessment and certification services and Euro-Cer t( notified body 1128) including:
 ATEX Directive (94/9/EC)
 Construction Products Regulation (CPR)
 EMC Directive (2004/108/EC)
 EU Medical Devices Regulation (MDR 2017/745)
 ErP Directive (2009/125/EC)
 Gas Appliance Directive (90/396/EEC)
 In-Vitro Diagnostic Directive (98/79/EC)
 Low Voltage Directive (2006/95/EC)
 Machinery Directive (2006/42/EC)
 Medical Device Directive (93/42/EEC)
 PPE Directive 89/686/EEC
 Pressure Equipment Directive (PED and TPED)
 Regulation (EU) 2016/425
 RoHS Directive (2011/65/EU)
 R&TTE Directive (1999/5/EC)
 Toy Safety Directive 2009/48/EC