| | Q: What is CE Marking?
A: CE Marking is the mechanism by which a manufacturer declares that their product complies with all the relevant European Union Directives |
| | Q: What products require CE Marking?
A: The CE mark is mandatory on all products covered by a EU directive. You will need to establish which, if any, of the "New Approach" or the older "Global Approach" Directives are applicable to your product. Wemtech can help with this process. |
| | Q: What does CE stand for?
A: The initials "CE" may have originally stood for "Conformite Europeen", although nowadays it's just a concept of conformity that has been adopted across the EU |
| | Q: What does CE Marking mean for my product?
A: CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country, facilitating the Free Movement of Goods in the EEC |
| | Q: Where must I display the CE Mark?
A: The CE Mark must be displayed in at least one of three places- on the product itself, on the packaging or in the manuals or other supporting literature. It is of course possible to display it one more than one or all of these places. |
| | Q: Who enforces CE Legislation in the UK?
A: Consumer goods are enforced by local Trading Standards Departments, and products used in the workplace by HSE. Medical and Automotive products are covered seperatly by the Medical Devices Agency and the Vehicle Certification Agency. |
| | Q: Who are the members of the European Union?
A: Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, and Sweden |
| | Q: What are the routes to certification?
A: There are three routes to certification- 1) Self Certification, 2) Technical Construction File, 3) Notified / Competent Body. |
| | Q: What is the Self Certification route to conformity?
A: This is where the manufacurer tests the product to the relevant harmonised standards and produces their own internal "Technical File" (note, different to Technical Construction File, TCF) and produces a Declaration of Conformity (DoC). |
| | Q: What is the Technical Construction File route to conformity?
A: A Technical Construction File (TCF) is needed when harmonised standards cannot be applied to a product. This can be if no applicable harmonised standard exists or a deviation from an existing standard has to be made because of the special nature of the product, including among other things, its size being too large for laboratory testing. |
| | Q: What is the Notified / Competent Body route to conformity?
A: This is necessary for certain types of product, and require a full test by a Notified / Competent Body |
| | Q: What is a Technical Construction File?
A: A Technical Construction File (TCF) is a loose-leaf document containing all relevant information to the compliance of the product. The file contains, among other things, the technical rationale for the test methods chosen, the product’s design details including designed-in EMC, test results and the declaration of conformity. The TCF also needs to be checked and signed off by a Competent Body and a certificate issued, and must be made available for a period of ten years. |
| | Q: What is a Declaration of Conformity?
A: A Declaration of Conformity (DoC) is a standardized document used to summarize the details of the apparatus' compliance. The manufacturer is required to issue the DoC and is responsible for it's content. All other third party references and signatures have no legal standing. You must hold your DoC "at the disposal of the Competent Authority" for ten years after the product enters the market. |
| | Q: What should be in a Technical Construction File?
A: As well as general product information, procedures used to ensure comformity should be included. These can be- technical rationale, details of significant design elements, test evidence. And also a Notified / Competent Body report. |
| | Q: What should be in a Declaration of Conformity?
A: Name and address of manufacturer (and agent), Name of Product, Name and number of directive, Standards used or TCF, Signature and date. |
| | Q: What is pre-compliance testing and how can it benefit our company?
A: The role of pre-compliance testing is to provide an early indication of whether equipment is likely to meet the requirements when full testing is carried out. It acts as a good guide to how close the product is to passing, without being too costly. |
| | Q: If my equipment fails a test and is modified, is it necessary to repeat all the tests?
A: This is a commercial issue. To be totally confident, testing should be carried out with the equipment in a final, production state. However if the modification is small, Engineering judgement could be used to decide whether further testing in necessary. |
| | Q: Can I relate the test results from one product to a range of similar products?
A: Generally the answer is yes, depending upon how similar the products are. The mechanism is called "Type Approval" with the principle being to show the worst case model passes, and thus all similar products should also pass comfortably. |
| | Q: What is Due Diligence?
A: This is when a company takes all reasonable steps to ensure that the product that they are entering on the market conforms to all the relevant Directives and Standards |
| | Q: Is a custom-made one-off item "placed on the market"?
A: The UK Regulations make use of the concept of supply rather than placing on the market, which makes the position clearer. Even one-off items are covered by the directive, when they are supplied for an end user. |
| | Q: What is a Notified / Competent Body?
A: A Notified / Competent Body (same thing, different name depending on the Directive) is a Government appointed body that has expertise and experience in conformity assessments. Notification / Competence is the process where the Member State informs the Commission that a body meets the designated requirements, such as knowledge, experience, resources, to conduct the conformity assessments. The Commission publishes a list of these for reference in the Official Journal. |
| | Q: What is a Competent Authority?
A: A Competent Authority (a.k.a. National Authority) is generally the member state's government agency responsible for control of the RF spectrum. |
| | Q: What are the "Normalized Standards"?
A: For a standard to be normalized it must meet three criteria: 1) It must be identified by an "EN" designation. 2) It must be published in the "Official Journal of the European Communities" (OJ). 3) It must be adopted by at least one of the member states. |
| | Q: What is the advantage of using a laboratory which is accredited by UKAS?
A: The United Kingdom Accreditation Service (UKAS) is the body responsible for accrediting laboratories in the UK. Once accredited, they are subject to regular scrutiny and this should offer confidence when testing and assembling Declarations of Conformity. |
