Each product is different, has different functions, target users,
is made of different components and different materials.
Therefore legal profile and CE compliance process vary for each product.
In other words applicable legal regulations will impose different requirements,
even if the items are quite similar.
CE consulting helps to understand complex matters of EU legal compliance.
That is to say it organises the available information and consequently allows
to make proper decisions.
For example let’s compare two simingly identical groups of products:
a walkie-talkie toy and a wooden toy train (not remotely-operated)
|GROUP OF APPLICABLE REGULATIONS
||Wooden toy train
Both of those items are electronic, battery-operated toys.
Hence regulations that apply to them are those that have toys,
electronic equipment and batteries as a subject.
Naturally they are sold in packaging so packaging regulations apply as well.
Also REACH regulation would apply as those articles contain various
substances (additive plasticizers or wood treatment chemicals).
However Walkie-talkie uses radio waves and as a result additionally
falls under Radio equipment regulation (RED).
The toy train, on the other hand, does not. To sum up, the more into details we get,
the more characteristics of those two items will differ.
The EU law makers are aware how complex the matter is. That’s why CEN and CENELEC come to our rescue.
Those two bodies issue harmonized standards. To clarify, harmonized standards are documents that cover specific requirements
for particular product type and indicate prodcedures of compliance demonstration with these requirements.
Moreover most of the harmonized legal acts introduce presumption of conformity.
That is to say – if it’s demonstrated that a product is compliant with the harmonized standard
– it’s presumed that it’s also compliant with the corelated legal requirement.
In fact there are several of them:
1.Check of publication. Not all harmonized standards create the presumption of conformity.
Only those, reference to which has been published in the OJEU. Therefore it’s worth checking first,
if such a publication has actually took place.
2. Selection. There may be quite many standards published, which could seem applicable
to your product at a first glimpse. However it’s not necessary to apply all of them just because
they are available. As we already said, the harmonized standards are related to specific legal requirements.
Consequently the decision, which harmonized standards to use, shall be based on the listed
requirements applicable to your product. In order to make that list of requirements – firstly
one must do a proper legal research.
3. Cost. Harmonized standards are NOT free. The cost of a single document is not
significant – it’s usually EUR 15 – 30. However you need to keep in mind that sometimes
there are more than 30 different standards applicable to a single product. At the same time
it’s usually not necessary to buy a the standard, if the testing would be performed
by a notified body (a qualified third party).
On the other hand it’s highly recommended to purchase the standard, if the testing
would be processed in-house (within manufacturing premises). To sum up, even if the
standard is applicable it may not be necessary to buy it.
In addition, one needs to keep in mind that even if the producer has followed the above
CE compliance procedure, the item may still need additional checks or tests.
To give an example: if, in the course of post market surveillance, a new hazard
related to the item is discovered.
Above all the presumption of conformity is not a guarantee, but just a pre-judgement.
CE consulting allows you as a producer to take a proper, individual approach to the product
and take a deep look into its specifics. To put it simply CE consulting allows you to focus
on only applicable requirements and be make sure that you meet all of them.
In the course of CE consulting you may either:
- get full elaboration of the legal status of your product (legal expertise), or
- get clarification, interpretation or, simply, answers to any questions you may have
as to the legal status of your product and your own obligations.
We are a team of lawyers, who specialise in manufacturing business area.
Easily navigating throughout EU legal regulations we provide compliance recommendations.
Contact us to inquire on CE consulting for your product.