| | Q: How do I decide if a printed wiring assembly should be CE Marked or not?
A: Boards intended for an end user should carry the CE Mark for EMC, backed by a Declaration of Conformity. Boards which are intended only to form part of another system, and intended to be incorporated into a finished product need not be marked, as they are components, and outside the scope of the directive. |
| | Q: I use a power supply in my system, does it require a CE Mark?
A: Power supplies come in many forms. If you are using it in a system then the system as a whole, at least, is tested for EMC and electrical safety. This process will also test the power supply. Hence there is no requirement for a CE Mark on the power supply alone as it's a component in the system |
| | Q: My company officers refuse to produce the doumentation required for their products. What do I do?
A: Most products today must be CE Marked before they are placed on the market. Your company officers are legally liable personally (they cannot hide behind the Ltd liability) to any accident that may occur. There is also a legal responsibility to have documentation available to prove the products are safe to put on the market. I suggest you write a memo to the Director advising him / her of the situation. At least you will be seen to have done as much as you can in these difficult circumstances. |
| | Q: I import products from outside the EU. Who is responsible for these products?
A: You are! It is important for the well-being of your business that you carry out what is called a 'Due Diligence' process on each and every product you import. This means obtaining full details of all the approvals, who tested & accredited the products. |
| | Q: I only make 1 off devices for clients. These are to order and differ each time. Sometimes the price of a 1 off is less than the cost for CE Marking. How do I reconcile this problem?
A: In simple terms you cannot. What is acceptable however is that you produce a technical file for each project. On the higher proced projects you allow for full testing. Over the years you will (or should) build up a range of technical files that generally covers most if not all of your designs. Assuming you carry out proper design reviews it becomes a fairly low-cost exercise to have proper technical documentation for each and all of your products. Even the very low-cost items. |
| | Q: I am manufacturing products to be fitted to motor vehicles. What do I require to ensure there is no problem with sales or ideed the product?
A: There are two main types of product for motor vehicles- 1) Those for additional information and entertainment, which need to undergo a simple set of tests, the costs of which are low and pre-compliance testing is recommended as the results must then be logged by the VCA (Vehicle Certification Agency). 2) Those that are connected to and have influence over the operation of the vehicle, which require a much more stringent test program.Only VCA approved test houses can fully accredit these products. |
| | Q: If an end user imports a product directly from a country outside the EEA for his own use only, does the product require a CE Mark?
A: Latest thinking from the enforcement authorities is that the end user takes the product into service, therefore no assessment, Declaration of Conformity, or CE Mark is required. The product has not been supplied within the EEA. However the end user may have to take action if interference is caused and it is shown that the product does not comply with the protection requirements of the directive. |
| | Q: I import products from China. It looks like another company is starting to market the same products, but does not have the modifications I fitted to achieve compliance. What can I do?
A: The first port of call will be to your local Trading Standards Officer. They will require you to voice your concerns, in particular the list of modifications required that could effect safety. The TSO will then advise local TSO in the area occupied by your potential competitor. This local TSO will then visit and ask to see their technical file. What happens then depends on the TSO, nature of the product, and potential dangers. |
| | Q: Does the signatory of a Declaration of Conformity go to jail if the product is shown to be non-compliant?
A: Not all offences under the UK Regulations could result in custodial penalties. Only Regulations 83 (contravention of a prohibition or suspension notice), 84 (giving false or misleading information) and 86(2) (impersonating an officer of law) carry this penalty. To date, no-one has been sent to jail in the UK for infringement of a New Approach directive. It is possible however, that this could happen at some time in the future for a very serious breach of regulations. |
| | Q: When is my product considered to have entered the market?
A: A product is considered to have entered the market when it is received by the consumer. A marked product can be warehoused in the EU. If additional requirements are adopted prior to delivery to the end user, it cannot be legally sold. If an apparatus is on order, and other requirements are adopted before the apparatus is delivered, the apparatus must meet the new requirements before delivery. |
| | Q: Our product needs to be tested to both the EMC and LV Directives. Can compliance with more than one directive be stated on one Declaration of Conformity?
A: Yes, providing all the relevant information is given for each Directive, the Declaration of Conformity can contain as many Directives as necessary. |
