CE marking
Are you familiar with Communauté Européenne?
Believe it or not, the answer is definitely yes!
It means European Community and is known by the abbreviation CE, i.e. the CE marking.
Application:
Often mentioned in the same sentence as the GS mark, it is not a test mark or seal of approval, but rather a declaration by the manufacturer, importer, authorised representative or distributor, in accordance with EU Regulation 765/2008, ‘that the product complies with the applicable requirements laid down in the Community harmonisation legislation governing its affixing’ .
It therefore confirms conformity with European directives before the product is placed on the market in the EU. As EU law is transposed into the national law of the member states, it coincides, for example, with the German requirements under the Product Safety Act, the Construction Products Act, the Medical Devices Act and the Ordinance on Electrical Equipment and the Machinery Ordinance. It is therefore a prerequisite for distribution in Europe and confirms basic health, safety and environmental protection requirements. The framework for this is provided by the EU’s New Legislative Framework, which defines the terms for legislation harmonising the European internal market.
Labelling requirement:
There are 30 different CE directives for which harmonised European product standards exist, whereby a product may also fall into several product groups. Conversely, this means that a product that is not subject to labelling requirements may not voluntarily bear a CE mark.
The CE marking, with a minimum height of 5 mm, must be affixed to the product independently, stating the manufacturer’s name and full postal address.
The European Commission provides a template for use: https://ec.europa.eu/growth/single-market/ce-marking/
CE marking is mandatory for the following products, for example:
- Active implantable medical devices
- Gas appliances
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Hot water boilers
- Lifts
- Low voltage
- Machinery
- Measuring instruments
- Personal protective equipment
- Pyrotechnics
- Radio equipment and telecommunications equipment
- Toy safety
- Electrical equipment for use within certain voltage limits
Declaration of conformity:
For products requiring CE marking, a declaration of conformity must be drawn up which, due to its legal binding nature, must be signed by an authorised representative.
Regulations specify whether this is done on the basis of a self-written confirmation of compliance with harmonised standards or whether a so-called notified body, such as auditing and certification bodies, must be involved.
It is imperative to ensure accuracy when drawing up the declaration, as liability may be incurred for any errors and authorities may order the submission.
It is therefore advisable to seek external help when preparing the documentation!
In order to prepare the documentation, it is necessary to research which guidelines, standards and regulations are relevant and whether a third party must be involved in the conformity assessment procedure. A risk analysis and risk assessment are necessary, and the technical documentation also takes a lot of time.
If you need assistance with this topic, please contact us.