CE mark FAQ
1) What is CE marking?
CE marking is a process that the manufacturer, its representative, or the importer takes to assure that the item meets all the essential requirements of all applicable directives.
The manufacturer, whether established inside or outside the Community, is the person ultimately responsible for the conformity of the product with the provisions of the relevant Directive(s) and for the affixing of the CE marking. The manufacturer may appoint an authorised representative established in the Community to act on his behalf. The person responsible for placing the product on the market may, exceptionally, be deemed to have assumed the responsibilities of the manufacturer.
2) When do I need to CE mark my products?
CE Marking is most probably required if you export to the 25 European Union member states (EU), the 3 candidate states for membership of the EU, and the 4 European Free Trade Association (EFTA) member states.
• 15 Original Member states
Austria (became a member in 1995), Belgium (Founder Member in 1957), Denmark (1973), Finland (1995), France (FM 1957), Germany (FM 1957), Greece (1981), Ireland (1973), Italy (FM 1957), Luxemburg (FM 1957), the Netherlands (FM 1957), Portugal (1986), Spain (1986), Sweden (1995) and the United Kingdom (Great Britain and Northern Ireland) (1973).
• 10 New Member states (after May 1, 2004)
Estonia (2004), Latvia (2004), Lithuania (2004), Poland (2004), Czech Republic (2004), Slovakia (2004), Hungary (2004), Slovenia (2004), Malta (2004), and Cyprus (2004).
• Candidate States
Rumania (applied for membership in 1995), Bulgaria (applied for membership in 1995), and Turkey (applied for membership in 1987).
• The EFTA countries:
Iceland, Liechtenstein, Norway and Switzerland
3) What is a Notified Body?
A Notified Body is an organization (often a third party certification or inspection body) that has been appointed by a member Government and Notified to the European Commission. A Notified Body will be appointed based on designated requirements, such as knowledge, experience, competence, independence and resources to carry out conformity assessments of products which need to be CE marked in accordance with the relevant directives.
CEM International Ltd has been appointed by the UK Department for Business, Innovation & Skills (BIS) as a Notified Body for the following directives:
4) How can CEM help me to CE mark my products?
How can CEM help me to CE mark my product
As a notified body for CE marking, we at CEM will be able to provide you with the most effective and professional service to enable you to CE mark your product. The service may include some or all of the following:
• Identification of applicable directives and harmonised standards
• Identification of test requirements, and making the necessary arrangements for testing your product
• Reviewing technical files
• Carrying out an on-site visit to ensure continuous coformity of your product to the directives
• Lodging your T(C)F
5) What are the procedures for CEM certification?
The procedure for certification includes the following stages:
• Application by the client
• Contract review by CEM
• Signing of the Contract by CEM and the client
• Assessment, including any necessary tests and the review of the T(C)F
• Implementation of correction and corrective actions, if necessary, by the client
• Recommendation from the technical assessor
• Issue of the certificate of conformity (or the assessment report)
6) How long does the certification process take?
There is no standard duration for our certification process. The time the process takes is largely dependent upon the following factors in relation to the product in question:
• Complexity of the product
• Test situation of the product
• Condition of preparation of the technical files for the product
• Cooperation and commitment of the applicant for CE marking services
7) What is a Declaration of Conformity ?
A Declaration of Conformity (DofC) is a legal requirement. The declaration is a statement that tells the purchaser of the product the directives and the harmonised standards with which the product complies and who, in the company, to contact in case of dispute.
8) Do I have to comply with the CE Mark Directives?
If your product is covered by a CE marking directive (of which there may be many), it needs to comply with all the relevant directives before it can be CE marked.
The CE marking directives are written into European law. The directives have to be converted into the National Law of each Member State. This is because there are different organisations who enforce the requirements of the directives in each country; the penalties will be different and, if financial, will have to be paid in different currencies.
In the UK all CE marking directives have been made criminal law. Failure to comply with the appropriate directive may result in one or more of the following actions: a fine, immediate withdrawal of product from the market; impounding of stock or, since an offence could result in a criminal conviction, a prison sentence.
9) Are EN standards the same as international ones?
Most EN standards are based on the international equivalent one. For example EN55022 is equivalent to CISPR 22. This helps manufacturers when designing products as it means that a single design will be acceptable for many different markets (with certain exceptions). This does not mean that market entry is automatically gained as there will be different administrative requirements through the world.
10) Who is responsible for signing the Declaration of Conformity and what is their liability in Law?
The following should at least help to clarify matters.
The Declaration has two purposes. The first is to provide the recipient (generally the user of the machine, or an enforcement officer such as the customs authorities or HSE) with some information about who was responsible for the CE marking of the equipment, what directives they CE marked it under and which standards they applied in order to do this.
The second purpose is to concentrate the mind of the ‘responsible person’ and make them consider whether the process of attestation to the Directive has been properly completed. As you will probably know, the CE marking directives all contain duties for the supplier of equipment which can generally be summarised as follows:
1. Ensure the product complies with the essential health and safety/protection requirements of the Directive (usually achieved by the application of appropriate standards);
2. Where series production is envisaged, ensure that manufacturing controls are in place so as to make sure that all products manufactured are compliant;
3. Maintain appropriate technical documentation;
4. Apply the CE mark to the product and complete the Declaration of Conformity.
Only when all of the above have been properly completed is it legitimate for the product to bear the CE Mark. The person who signs the Declaration should have the knowledge that these things have been done, and it would be appropriate for it to be someone whose management responsibility includes the processes that the above duties entail.
In signing the Declaration, the signatory makes a binding commitment on behalf of the Responsible Person (which may be a corporate body, etc.) that the above processes are properly completed. They sign as a representative of the Responsible Person, and their personal liability is dependent on their responsibilities within the company. Both individuals and companies can be held responsible for the activities of a corporate body. Normally the director(s) of a company are held liable for any activities of that company, but if the directors can show that they fulfilled their duty to provide good management and adequate resources to their staff, and it was the actions (or inactions) of a junior staff member which caused a breach, the junior staff member will have to answer for their personal actions rather than the Director. Directors have certain specific duties which is why they have to be formally appointed and notified to Companies House, but all members of staff have other legal duties which are appropriate to their position, and just because someone is not a Director does not mean that they cannot be brought before the Courts and asked to account for themselves in the event of the company making a major error in which they were involved.
It’s an important point of law that you cannot re-assign your criminal obligations by contract, although you may be able to subcontract the actions which fulfillment of those obligations entails. A company Director has many duties under the law, and most of the actions which those duties require are actually delegated to junior staff. CE marking obligations are just further such duties, which a Director will assign to appropriately qualified staff. However, the duties remain the legal responsibility of the Director and just because he tells someone else to sign the Declaration of Conformity does not mean that he is not liable if the work is not done correctly.