|A Quick Walk-through|
A Quick Walk Through the Directive (but slowly through the juicy bits!).
This paper is intended to give an insight into the R&TTE directive from a manufacturer's point of view. At each of the articles you can link instantly to the relevant place in the directive and use the "back" button to return here. The articles shown in bold type are of most interest to a manufacturer or supplier.
The first part of any European Directive is a justification why the directive was written the way it is. You won't want to waste time reading lots of paragraphs starting with "Whereas" but if you suffer from insomnia they are more powerful than any sleeping pills you can buy!
Article 1 Scope - Details which equipment is covered by the directive, i.e. Radio Equipment and Telecommunications Terminal Equipment; (see Definitions in article 2). Special mention is given to Medical and Automotive devices such that this directive applies but without prejudice to their own directives. It should be noted at this point that Annex I contains a list of excluded equipment and in particular, equipment intended for military or police use is excluded. Thus the exclusions are: (this list is simplified, be sure to read the directive in order to determine if a particular type of equipment is excluded).
Article 2 Definitions - Gives detailed definitions of the terms used. There is no point in simplifying these any further, just read them.
Article 3, Essential Requirements - This is the real meat of the directive and deserves a more detailed treatment. A major difference between this directive and it's predecessor, the TTE directive, is that there are no performance requirements for connection to the network. Non-radio telecoms terminals need only meet requirements for Electrical Safety and EMC, it is considered that market forces will exclude terminals that do not perform well.
The best way to demonstrate conformance with these requirements is by testing but care must be taken to avoid excessive costs.
3.1(a) This is the requirement for Health and Safety and calls up the Low Voltage Directive (LVD). Normally the LVD does not cover battery operated devices but with the almost throw away line "... but with no voltage limit applying." they are included if they come within the scope of this directive.
As safety testing is a mixture of inspection and testing there are a number of options in the way the assessment is performed. If you are using a third party test laboratory you should find out what options they have available so that you can minimise costs.
3.1(b) The EMC requirements are called by referencing the EMC directive. The easiest route is to test to the correct standard but careful planning and design are required if re-tests and escalating costs are to be avoided.
3.2 Radio equipment has this additional requirement to avoid harmful interference. This includes parameters such as Effective Radiated Power, Frequency Stability and Spurious Emissions. Also implied by this requirement is that the use of the frequency must permit the intended application. As an example, the PMR446 frequency band must not be used for data transmission.
3.3 To understand these requirements we have to know a little about the history behind them. Prior to this directive telecoms equipment was highly regulated and there were many performance requirements to ensure correct operation over the network. The R&TTE directive radically changed the situation by relying on market forces to ensure operational integrity. As you can imagine, many representatives were fearful that networks might be deluged with malfunctioning equipment that might impact the service so article 3.3 was added so that performance requirements could be added later if required.
Currently only 3 requirements have been implemented under this clause, all of them for radio equipment. Each has it's own European Commission Decision:-
If you don't fall into one of the above categories you need not worry about article 3.3.
Article 4 Notification and publication of interface specifications - Places a requirement on member states (countries) to notify the commission of interfaces that are provided in their country. There is a further requirement on telecom Network Providers to publish details of their network interfaces so that terminals can be designed.
Article 5 Harmonised Standards - Introduces Harmonised Standards that can be used to demonstrate compliance. This article describes the procedure used by the commission to amend or withdraw these standards. A list of standards, and the type of equipment they can be used with, is published in the Official Journal of the European Community, which is often abbreviated to the "OJ". A copy of this list, with thanks to the Europa website (www.europa.eu), is available here.
Article 6. Placing on the market - A number of important points are given regarding "Placing on the market".
6.1 inhibits member states from imposing additional requirements. I use the word "inhibit" rather than "prohibit" because some states did try to add requirements when the directive first came into force but were eventually made to remove them.
6.2 provides safeguards for existing equipment. If it becomes subject to a new essential requirement as a result of article 3.3 of this directive it can continue to be sold for a "reasonable period" determined by the commission.
6.3 requires the supplier to provide certain information to the user and in some cases this needs to be on the packaging. There are particular requirements when the equipment is a radio and has potential restrictions or cannot be used in some member states. Telecoms equipment has to have details of which interfaces it is intended to attach.
6.4 Spectrum Usage Notification. This is a new and very important requirement introduced in this directive. If you sell radio equipment that uses frequencies where the usage is not harmonised throughout Europe (this is the case with most radio equipment), you need to notify the Spectrum Usage Authority in each European country where you intend to market the product. If your equipment is in this class you will need to use the services of a Notified Body, either by submitting your Technical Construction File as in Annex IV or by using the Full Quality Assurance route as per Annex V. The notifications should be made as soon as possible and at least four weeks before the launch of the product in that country. Although the directive says four weeks before placing on the market, some countries have different interpretations of when that four weeks starts so you may find that a request for slightly more information will reset the clock and you start the four weeks all over again.
Article 7 Putting into service and right to connect - Equipment that complies with the directive must be allowed to be "put into service" and network operators must not refuse connection. There are, however, some safeguards so that if equipment is found to cause "harmful radio interference" or "serious damage to a network" it can be forced to be withdrawn from service. The detailed procedure to be followed in such a case should ensure that this provision is not abused.
Article 8 Free movement of apparatus - Member States should not restrict the free movement of equipment that meets the requirements of this directive and displays the CE mark. At Exhibitions and Trade Fairs equipment that does not yet comply can be displayed provided it is clearly indicated that it cannot be put into service. Where equipment comes under other directives as well as the R&TTE the CE mark will normally indicate compliance with all the relevant directives but where, due to transitional arrangements, this is not the case the CE mark should indicate which directives are compliant.
Article 9 Safeguards - Unlike it's predecessor, where once you held an approval it was unlikely that any surveillance measures would be taken, this directive encourages member states to set up surveillance authorities to check equipment to determine if it is compliant with the directive.
Article 10 Conformity Assessment Procedures - This article lays down the ways that compliance to the essential requirements, given in Article 3, can be demonstrated, although the details are given in the referenced annexes II, III, IV and V.
10.2 - we saw in Article 3.1 that the essential requirements for health and safety are given in the Low Voltage Directive and likewise the EMC requirements in the EMC directive. Here the manufacturer is given the option of using those two directives to demonstrate compliance. This becomes useful when a range of models is produced and not all of them come within the scope of this directive. To give a trivial example: a range of Tea Makers has a modem in the Top-of-the-Range model so that you can phone home and start the tea making process before you get there. Only the model with the modem comes under the R&TTE Directive but the whole range can be taken through the EMC directive and the LVD, it is then only necessary to make a declaration under the R&TTE directive for the modem model based on the EMC and LVD compliance.
10.3, 4 and 5 give the manufacturer the options for using the relevant annexes.
|Radio Transmitter||Not a Radio Transmitter|
|Harmonised Standards applied in full||Annex III, IV or V||Annex II, IV or V|
|Harmonised Standards not applied or applied in part||Annex IV or V||Annex II, IV or V|
More details of the Assessment Procedures will be given under the relevant annexes.
10.6 Requires that the correspondence with the Notified Body should be in a suitable language.
Article 11 Notified Bodies and Surveillance Authorities - Requires the Member States to set up Notified Bodies and Surveillance Authorities and a list will be published in the Official Journal (OJ). This list can be found on the Europa Web Site (www.europa.eu.int).
Article 12 CE Marking - All good CE Marking directives have a section to show how the CE mark should be displayed, and this is it! Where the manufacturer just uses the self-declaration route, Annex II, only the CE Mark is applied but if the services of a Notified Body are used the CE mark is followed by the notified body number.
Radio equipment also needs a Class Identifier mark if it comes within that class. Currently only one class identifier has been assigned, , Commission Decision 2000/299/EC for radio transmitters using frequencies who's use is not harmonised across Europe (which includes most of the frequency spectrum). As an example, a PMR radio demonstrating compliance with Annex IV and using BABT as the notified body would have the mark CE 0168 followed by the Class Identifier mark, .
Note that the equipment must be identified by batch and/or serial numbers and the name of the manufacturer or importer. It must also be identified by its name and/or type number as shown in the Declaration of Conformity.
Article 16 Third Countries - Although rather curiously worded this article is intended to encourage countries outside of Europe to accept equipment that complies with this directive. Indeed, a number of non-European countries have adopted this directive in full or in part.
Article 17 Review and reporting - Provision for the commission to report to the European parliament every 3 years about the state of this directive and to make changes if necessary.
Article 20 Repeal - This directive repeals it's predecessor and this article also states that equipment within the scope of the R&TTE Directive does not need to comply with the LVD or EMC directives except for the parts we have seen earlier.
Article 21 Entry into Force - This directive is already in force!
Article 22 Addresses - This is the normal concluding article in a European directive, the names of those who presided at the time.
Demonstrating Compliance - The following 4 annexes detail different ways of demonstrating compliance, it is important to choose the correct route for your product type and marketing requirements. They can be considered as increasing in costs to third parties (but not necessarily increased overall cost) and decreasing in risk. Annex II has the greatest risk but no notified body Costs, whilst Annex V carries minimum risk but with annual payments to the notified body.
Remember that you do not have a full choice over the annexes you can use, see article 10.
Annex II Internal Production Control - This is often referred to as the "Self Certification" route as there is no involvement of a notified body. Under this route the manufacturer, or his authorised representative (usually a distributor) has to ensure the following:-
This last point is often overlooked because there are no provisions to enforce it. However, it is foolish to ignore it because any uncontrolled change to the product could make it different to that described in the documentation and render the compliance invalid.
Annex III Internal Production Control plus Specific Apparatus Tests - This includes all the requirements in annex II but where radio equipment does not have test suites defined in the relevant harmonised standard or no harmonised standard exists, a notified body must be used to identify suitable test suites to use. The manufacturer must declare that the equipment complies and affix the notified body number after the CE mark.
Annex III has been treated by some manufacturers as a loophole to get the notified body number without having to submit the TCF under annex IV. Because of this a number of Notified Bodies will not process an annex III application if the test suites to use are easily identified. Most manufacturers that use this annex follow up with an annex IV application.
Annex IV Technical Construction File - This procedure includes all the elements of annex II and, where applicable, annex III but the Technical Construction File (TCF) is submitted to a notified body for assessment. The notified body issues an "opinion" as to whether compliance has been adequately demonstrated. Strictly speaking they only need to issue an opinion if it is negative but most Notified Bodies will issue positive opinions as well. BABT, for example, issue a positive opinion as a certificate that can be included in the TCF to give it more credibility.
Here is a summary of the advantages and disadvantages of annex IV compared to annex II:-
Most Notified Bodies will allow the annex IV route to be used for part of the essential requirements. For example, a telecoms product might use annex IV for the EMC requirements but use annex II for safety.
Annex V Full Quality Assurance (FQA) - Under this annex your Quality System for design, manufacturing and testing is audited by the Notified Body which then allows you to introduce as many products as you wish without having to submit product information to them. You still get to use the notified body number after the CE mark.
This option is attractive to manufacturers that produce a number of new products each year but it is not just for the big players. Many medium sized companies have benefited from this approach and some Notified Bodies offer good packages with a number of additional benefits as well as being the minimum risk route. BABT, for example, offer a comprehensive package, which includes access to a consultant to address issues before they become major problems.
If you choose to use this route you should also consider combining your FQA and ISO 9000 registration, as many of the requirements are common.
Annex VI Designation of Notified Bodies - This annex simply lists the criteria to be used by member states when designating Notified Bodies and is of no particular interest to a manufacturer.
Annex VII Marking of equipment - Here we have the dimensions of the CE mark and the Class Identifier for equipment using non-harmonised frequency bands. The class identifier, , was decided later so is not illustrated in the directive.