CE Marking - Frequently asked Questions
1. Why should I be bothered about CE marking?
1.1 If you want to sell (most) goods into the European Market (EU.), you
will need to have the CE marking on your product. Consider the marking
as a kind of passport for your product, into the 25 member states of the
European market.
2. What if I don't want to put this CE Marking on my goods?
2.1 If your goods are covered by one of the DIRECTIVES, then you have
just made a decision not to sell your goods into the EU. Without the CE
Marking you will not sell into the EU.
3. I looked at the DIRECTIVES and my goods are covered, but they don't
have the CE marking as my goods were being sold in the EU. before the
Directive came into force
3.1 If you want to keep selling them, you have to get the CE Marking on
the goods.
4. How do I go about getting CE Marking?
There are 5 definable stages:
A. Select the Directive and the Harmonized Standards that relate to your
product
Directives and Harmonized Standards can be found on the
Internet.
B. Using the Essential Requirements and Harmonized Standards, assess
(categories) your product
This can be a Self-Declaration, Voluntary Certification or Mandatory
Certification (The directive will describe which method is acceptable)
C. Compile a Technical File
Information on what has to be contained in Technical files is described
in the related Directives.
D. Compile and Sign the "Declaration of Conformity"
You state that your product complies with the requirements of the
related Directives and Harmonized Standards, including possible testing
to EMC and safety requirements.
E. Attach the CE Marking to your products
You create the Labels in accordance with specific requirements
described in the CE Marking Directive and attach one to each of your
products
5. Can I do all the work necessary myself, to apply the CE Marking to my
Product?
It depends on which broad category your product resides in. Carry out a
risk assessment then, if it is considered:
Simple design
The manufacture may be able to carry out the necessary operational
checks as may be necessary to demonstrate compliance with the
requirements, alternatively, if it is considered:
Intermediate design
The manufacture may need to employ a notified body to carry out the
necessary operational checks as may be necessary to demonstrate
compliance with the requirements. Lastly, if the product is considered:
High Risk Design
The manufacture must employ a notified body to carry out the necessary
operational checks necessary to demonstrate compliance with the
requirements. In many instances this will need the support of a quality
assurance system assessed by an approved third party quality auditing
organization.
Note that "Self Assessment" will most likely be challenged, be prepared
to support your conclusions.
6. Do I need to have a Quality System as well?
This needs to be assessed, based on the Directive to which you will
comply, as follows:
Title
Notified body
to
either Test and
examine or review
technical
Documentation Quality System
Low Voltage
Often
Not a requirement
Simple Pressure vessels usually Not a requirement
Electro Magnetic Compatibility often Not a requirement
Machinery Sometimes Not a requirement
Medical Devices usually usually EN46000
Gas Appliances Always usually ISO9000
Active Implantable medical devices Always Always EN46000
Telecommunications Always usually
Personal Protective equipment usually usually ISO9000
Construction Products Often often
Toys Sometimes Not a requirement
Non-Automatic weighing machines Always Often ISO9000
Hot water Boilers (efficiency) Always usually
If you need assistance with all or some part of the above, call or e-mail AQAS
E-mail: sales@aqas.com.au