CE - Frequently asked questions
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
Before CE marking your product, you need to apply the conformity assessment procedure, as specified in the relevant EU Product Supply Directive. The basic process is to carry out a risk assessment, considering all the essential requirements relevant to your product and ensuring you have met them. Standards may help in meeting these requirements, with some standards giving a presumption of conformity to the Directives. As manufacturer, you have to declare the product's conformity with all relevant product supply Directives when you place the product on the market.
For much work equipment, you can carry out this procedure yourself, provided you have access to the necessary engineering expertise, although you may wish to use the services of a consultant. However, for some products - such as those listed in Annex IV of the Machinery Directive, and most lifts, much pressure equipment and all gas appliances - the use of a notified body is required. They will issue you with a certificate of adequacy or conformance. You can then apply the CE mark and issue the required Declaration of Conformity, quoting the notified body's name, address and unique identifier.
No. This only applies to those products that come under one of the relevant product supply Directives that require CE marking, for example:
- pressure equipment
- low-voltage electrical equipment
- equipment for use in potentially explosive atmospheres
Products that do not fall under these Directives - such as manually-powered machinery (except those used for lifting), tools and ladders - must not be CE marked.
Yes. When you combine a series of complete machines and / or partly completed machines so they operate as a single assembly line (ie under a single control system), you have to:
This must be done for the complete assembly line as a whole, even if each individual machine has its own CE mark. The technical file only needs to contain the design details and drawings of any control systems and other parts you've had to supply or modify, and the Declarations of Conformity / Incorporation for each of the items in the line.
In most cases, no. However, you need to ensure it is safe and continues to meet the requirements of the Provision and Use of Work Equipment Regulations (PUWER). Depending on the modifications, you may wish to get advice from the original manufacturer and will need sufficient engineering expertise for the type of modifications involved - you may need to bring this in if not available in-house.
- is so extensive that the item is basically a new machine
- affects the function of safety devices or systems, or
- introduces significant hazardsthat could not have been assessed in the original design, such as converting a manual machine to full computer control
A Declaration of Conformity (DoC) is a formal written statement by the manufacturer or their authorised representative, stating that the product meets all relevant product supply Directives (occasionally there may be several DoCs, one for each Directive). For details about the other information that must be included see the Declaration of Conformity page
The Declaration of Conformity and the nameplate on the product must contain the name and details of the legal entity taking fu ll responsibility for the product. If your trading name is registered to your company then it can be used. This can also be done if the product is made by another company. However, if your company name is on the DoC then you have to take on all the manufacturer's duties under the relevant Directive. These duties include supplying technical information on request to any European market surveillance authority, and being fully responsible for the product's design and user information.
A Declaration of Incorporation (DoI) is a formal written statement, very similar to a Declaration of Conformity. However, the DoI states that 'the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of this Directive'.
The Declaration of Incorporation may only be issued for partly completed machinery, which cannot operate independently. It enables identification of the original manufacturer of the part and shows the customer that it complies, as far as it is able, with the Machinery Directive.
Instructions for the safe and correct assembly of partly completed machinery must be provided along with the DoI but the product must not be CE marked. When the customer has incorporated the partly completed machinery into a complete machine and CE marked the final assembly, they should place the DoI in their technical file.
If such items are supplied independently to customers, including other manufactures who use the items in their own products, they are considered as 'safety components'. Under the Machinery Directive, these must be CE marked and meet the conformity assessment requirements (as if they were machinery). The exceptions are where such components form part of a complete machine (in which case the machine's CE mark covers these items too); or if they are supplied as spare parts by the original machine manufacturer.
No. This file contains confidential information that the manufacturer does not have to release to their customers. However, manufacturers must supply full instructions for the safe use of the product, as well as certain other information, such as the noise and vibration levels of the machinery, and how to combine the item with other products (if this is envisaged).