Frequently asked questions
What does CE Marking stand for?
There is some debate... but it is generally thought that CE stands for "Conformité European". It is intended to facilitate the free movement of products within the EU by signifying that essential health and safety requirements have been met. It is not a quality mark or a specific statement concerning the test methodology that has been employed
What is CE Marking?
The CE marking is the manufacturers (or distributors) claim that the product meets the essential requirements of all relevant EU directives are satisfied. If a product requires CE-marking, it cannot be legally "taken-into-use" in any of the EU countries. The term "taken-into-use" applies to a wide range of situations including,
- Sold and delivered to a customer
- Hired out
- Given away!
- On loan
- Demonstration equipment
- Your own in-house equipment
CE marking a product is not an option; it is required by law if the product falls under one of the European Union New Approach Directives. The CE mark indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.
When considering any new product development or improvement it is essential to consider the regulatory requirements. It is always easier to design in compliance rather than to try and sort things out once the product has been made.
Why have CE Marking?
CE marking was introduced throughout the EU for the following reasons ,
- To harmonise standards through the European Union
- Create a single European market
- Protect the consumer/custome and the environment
- Simplify the lives of manufacturers!
The last point often comes as a surprise to people involved in the manufacture of products, however before the introduction of these harmonized standards it was not uncommon for a manufacturer involved in export to have to "jump through a variety of compliance hoops" for each European country.
What type of products need to be CE marked?
The official answer to this is anything that is covered by the New Approach Directives or older Global Approach Directives. CE marking only applies to products within the scope of these Directives and should not be applied to products if they are outside the scope. The problem is that there are a large (and growing) number of directives and interpretation of them is not straight forward. We've been doing this for a long time and so can help, often if a product is outside the scope we can tell you pretty quickly, and unless this take a vast amount of time (so borderline products take a lot of work), it will cost you nothing.
Should all products be CE Marked?
The simple answer is NO! Only products within the scope of the "CE Marking" directives should bear the CE Marking. Increasingly manufacturers are being asked to CE mark "inappropriate" products.
Does my product need to be CE Marked?
A simple question which can take a while to answer! The "directives" page gives an outline of "scope" of each of the CE Marking directives so have a quick look. Chances are you'll still be a little confused, so give us a call or email us. We don't charge for initial discussions and a lot of people go away happy without ever paying for our services
I just sell/import , does it affect me?
Any product offered for sale in the EU must carry the CE marking (if it is covered by the directives), if the product has not been put through the process by the manufacturer then it will be your responsibility... so beware.
Is third party testing/involvment required?
In most cases no, ... but some compliance requirements involve the mandatory use of approvals or certification bodies. In some cases the requirement for the involvement of a "Notified body" depends on the route chosen to demonstrate compliance.
What is a Notified Body?
These are organizations appointed by each member State under the appropriate national regulations to conduct third-party conformity assessment procedures to the product in question or its production processes, as required by the Directives, in order that it may carry the CE Marking. The procedures vary according to the Directives and third-party involvement is not compulsory for all products. Manufacturers can use the services of Notified/Approved/Competent Bodies in any member State of the European Community. Normally Notified bodies are only involved when considering higher risk products or for some directives when appropriate standards have not be applied or only partly applied. It should be noted that Notified bodies are not "permitted" to provide advice concerning solutions to any problems that are found, although a good one will provide off-the-record guidance.
Is PCL a Notified Body?
No, we are a Consultancy that can help with CE Marking, however we do work closely with Notified bodies as required. Being an independent organization we are able to provide detailed assistance concerning solutions to problems and even help to implement those remedial actions. When a project does require the involvement of a notified body, we can help to define the scope, identify a suitable body and act as liaison throughout the project.
What does the CE Marking signify?
CE marking indicates that a declaration has been made by the manufacturer (or distributor/importer) that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives.
What is a Declaration of Conformity?
A declaration of conformity (DoC) is a document (usually a single page) that is produced by the Manufacturer (or distributor/importer) that provides addition details in support of the CE Marking. The detailed requirements for a DoC depend on the individual directives but a typical DoC will include the following i) of contact details for the manufacturer (or distributor/importer) ii) information concerning which directives have been covered and any standards that have been used and iii) details of the designated signatory and iv) details of any notified body that might have been involved. It is common for customers or prospective customers to ask for copies of the Declaration, the must be supplied on request.
Is a Certificate of Conformity the same thing?
No definitely not!, A "Declaration of Conformity" has a specific legal status, a CoC is something that someone might issue in relation to quality control saying that it complies with specification.
Do you issue a "Declaration of Conformity"?
A "Declaration of Conformity" cannot be issued by a third party, it must be signed by the manufacturer, authorised represenbtive or importer. But we can help you put one together.
What is the Process?
The process that you need to go through to be able to CE-mark your products vary widely and depends on a number of things including,
- The applicable directives
- The product itself
- The target user/customer
- The market requirements
- The manufacturers choice (in most cases)
In a majority of situations, the New Approach Directives allow self-declaration in place of third party involvement; but the right to self-declare compliance with the law means that a manufacturer must be responsible for completing all the procedures required by the law and must be able to prove it. This is done by the production of technical documentation (generally referred to as a Technical File).
The Technical File is the written justification that all aspects of a product are safe and should be prepared before the product is placed on the market. The Technical File includes information that demonstrates the technical basis for conformity of the product to the applicable requirements of the directive. The manufacturer must keep the Technical File for ten years after the last unit is placed on the market, unless the directive provides for a different duration.
What is a Technical File?
The CE marking process revolves around the construction of a technical file for the product. This is intended to cover all of the essential details that shows that the product complies. It supports the DoC but is a company confidential document and need only be produced in the event of a legal challenge, or in some instances when requested by government bodies.
How long do we need to keep the file?
Normally the technical file must be kept for a defined period (usually 10 years) after the product is withdrawn from the market
Who enforces the process and what would happen if I don't CE Mark a product?
In the UK, enforcement varies according to the Directives. Some are enforced by local Trading Standards Departments, others by HSE and yet others by the Medical and Healthcare Products Regulatory Agency and the Vehicle Certification Agency and OFCOM. Except where safety is at risk, the relevant enforcement authority will usually provide you with an opportunity to ensure that your product is correctly CE-marked. If you fail to comply then you will be obliged to take your product off the market, and you may also be liable to a fine and/or imprisonment
Who can help?
Depending on the product, We can! , give us a call
What is your approach?
Understanding the requirements for CE Marking can be complex and time consuming and is something of a diversion from most the mainstream of most businesses. Our assumption is that you do not want to become an expert on CE-marking; you just want the problem solved quickly and with the minimum disruption to your business, That’s what we do!
Over the years we have found that the most effective way of establishing a sustaining CE –marking process within a business is for us to lead the process and assemble the technical files etc for the first product. We use this time to transfer the knowledge to people within the business so that when we leave the process is sustainable and can be applied to subsequent products. In these circumstances we can provide assistance to your in-house team in the following areas,
- Determining the relevant directives
- Review of product and process
- Practical advice and assistance with problems
- Preparation of the Technical File
- Assistance with 3rd party testing if required
- Provision of Declaration of Conformity (or Incorporation) formats
- Assistance with modification of user documentation
- General advice and assistance
Our approach differs from many other “Compliance organizations”, as a result of our personnel’s many years of experience in the product development and manufacture. We will never just accept that a product fails a particular test; we will delve into the reasons and try practical solutions to remove the issues. Ultimately a problem may be too serious and require redesign or remanufacture but you can rest assured that Petts Consulting Limited will have made it best effort to ensure that the product legitimately passes the assessments.
What will it cost?
Costs vary greatly depending on the product, the directives and the requirement for the involvement of notified bodies. We can usually provide a fairly good estimate of the likely costs once we have information concerning the product. The more information you can give, the better service we can give you. All information is kept in strictest confidence.
How long does it take?
Again this is highly product dependent, we have done the process in less that a week but typically a elapse time of 2-3 months is more normal.
Statement: Petts Consulting Ltd will provide an Organization with the knowledge of the Directives and an appropriate process which, when applied correctly will demonstrate due-diligence. However, the CE-marking is the manufacturers claim that the product meets the essential requirements of all relevant European Directives. In many cases the process to be carried out is a self-declaration process and the responsibility for any decisions lie with the management of the Company. During the course of the project Petts Consulting Limited will provide guidance and advice but ultimately it cannot be held responsible for such decisions.