CE Marking The
CE mark is about enabling free trade of safe products throughout
Europe in a legally accountable manner. But like most legislation
it can sometimes prove confusing. We aim to translate the legalistic
and techno-speak into no-nonsense actions that you can apply.
Call us for a no-obligation,
confidential discussion about your requirements.
CEMarkit is normally asked:
1. What needs to be done?
2. How long will it take?
3. How much will it cost?
If you can provide us with some basic product
information (sales literature / instruction manuals) we can let
you know and our experience is that clients are pleasantly surprised
with what we can do.
We will provide you with a fixed price quotation
for the full CE marking job, or we will be equally pleased to work
with you on a day rate basis – as suits you best.
Either way, the procedure to be followed is fairly
consistent to all clients: Assess
Identify relevant New Approach Directives.
Classify product and identify the best Conformity Assessment Route.
Research relevant Product Conformance (BS/EN) standards.
Inspect
Conduct Hazard Analysis
Create Essential Health And Safety Requirements (EHSR) reports.
Test the product to conformance standards or source specialist external
testing services on your behalf as appropriate.
Review
Operator and Maintenance instructions.
Technical drawings and circuit diagrams.
Supplier information.
Quality procedures to ensure conformity of series production.
Sales literature (where relevant).
Record
Build the mandatory Technical File.
Create a Declaration of Conformity / Incorporation for the product
as appropriate.
Training Additionally, we can provide CE mark training, where
we would take you through the European legislation and the methods
used to comply.
We have delivered CE training sessions to large
groups at companies, Business Links and Chambers of Commerce as
well as smaller teams or even one to one learning.
You can choose a standard training package or
if you would prefer we can tailor the training to suit your organisations
requirements.
Please contact
us to discuss what we can offer in more detail.
Examples of Typical Work:-
1. Japanese Medical Device Manufacturer requiring
Notified Body Approval
This Japanese manufacturer wished to enter the European Medical
Device market, but did not understand how to. We assessed the product
and completed Technical Files, sourced a Notified Body on behalf
of the manufacturer, advised them and co-ordinated auditing of the
company in Japan.
2. UK manufacturer with Health & Safety Executive
(HSE) investigation
An HSE investigation required a manufacturer of food processing
machinery to provide a copy
of a CE certificate and Technical File for its product. The manufacturer
was not in a position to supply the information. We conducted a
CE marking exercise, creating an action list of product improvements
for the manufacturer and we provided the necessary compliance documentation
to HSE within six weeks to their satisfaction, keeping the product
on the market.
3. European distributor asked by Customer for
CE certificates
A European distributor was asked to provide a Declaration of Conformity
for their product prior to gaining a large contract to supply a
machinery hire company. Although the product had been sold successfully
in the USA with no safety problems, the machine had not been assessed
to European Safety Regulations. The machine was tested and recommendations
made for ‘European modifications’ within two weeks of
the original contact.