Counter question: does your product have an antenna?

It may sound strange, but this question is sometimes not so easy to answer.
At first glance a product might appear to have no visible antenna but could still be considered a radio product according to the Radio Equipment Directive 2014/53/EU (RED).

In these cases antennas are often glued to the inside of the housing or implemented directly on a printed circuit board. Products that support wireless charging, for example, may also fall under the Radio Equipment Directive and must be evaluated accordingly.

We will be happy to support you with your specific concerns and work with you to find the best solution for you.

If your device contains a radio technology, the Radio Equipment Directive 2014/53/EU (RED) is applicable in most cases in the European Economic Area. It should be noted that the RED includes the requirements of both the EMC and the Low Voltage Directives. The RED even goes a bit further and overrides the voltage lower limit of the Low Voltage Directive, at least for handheld terminal equipment. Depending on the product, other directives (machines, motor vehicles, toys, ...) may also apply. In this case, it is primarily the manufacturer's task to record this in a suitable risk analysis.

So-called radio modules must also be subjected to a conformity procedure before being placed on the market. Therefore, they also fall under the RED. If a radio module that has been declared compliant and is subsequently integrated into another device, a number of points must be observed. In addition to newly developed standards, it must be considered in general terms that the product in which the radio module is integrated then falls within the scope of the RED. The "integrator" becomes the manufacturer of the new product and is thus responsible for the end product in the sense of the RED. Among other things, the basic requirements in Article 3 of the RED must be met.

Assistance is provided by ETSI EG 203 367, which distinguishes between the following scenarios for module integration:

Radio technology and non-radio technology are largely independent and can be easily separated. Furthermore, the devices are placed on the market independently of each other. This is called "combined equipment" and a combination test is recommended.

Non-radio technology and radio technology are inseparable. The entire terminal device becomes a radio system. Integration testing of radio technologies.

The integrator does not follow the manufacturer's specifications of the radio technology. Thus, a new radio product is created. A complete conformity according to RED must be performed on the end device.

If you want to read more detailed information about this topic, please have a look at the REDCA Technical Guidance Note 01 under the following link

Our article will give you guidance for this! The earlier you address the issues in the development of your products, the better.

The choice of countries not only has a decisive influence on which tests are required for your product, but also on which frequencies they are allowed to use and which components they can use.

Therefore, the question "Where do I want to market my product?" must be asked BEFORE the product is developed, if possible.

Why? Well, cost, cost, cost!

• Costs for the actual approval
• Costs for testing according to country-specific requirements
• Costs for handling (test samples, deadlines, shipping, fees, etc.)

Furthermore, you should also familiarize yourself with the regulations and requirements of the respective countries. For example, how many transmitters are installed in your device and the size of the device may play a role. Later re-designs due to insufficient planning are expensive and cause unnecessary stress. Therefore, prepare well!

Is a pre-certified module what you want to integrate also pre-certified for the countries where you want to market your final product?

Which tests are then necessary? Which approval strategy is then the most suitable?

As an expert for radio products and their approval, our team will be happy to support you in answering these and other questions.

Which test requirements and guidelines you should / must observe can only be answered concretely when it is clear in which countries your product is to be marketed. In some cases, as in the EU, a large number of countries fall under one directive (2014/53/EU). Some other countries, such as the USA and Canada, have different testing and certification requirements despite being geographically close to each other.

Whereas also in some countries, such as Brazil, test results from foreign laboratories are not accepted, but the tests are partly performed according to the same testing standards as in the EU. Which automatically leads us to the next question:

A point that is relatively easy to answer: The more countries, the higher the costs and the time required. Unfortunately, these factors are not in a linear relationship to each other and must be considered individually by our team of experts. After all, the following also applies to accreditation: different countries, different customs. Requirements, tests, costs, and speed of approval vary from country to country.

The following costs for an approval of radio products must be considered:

• Fees for authorities, notified bodies, external service providers
• Shipping costs for test samples abroad
• Testing costs
• Approval planning and management
• Customs duties

As a professional service-provider, our team here at Phoenix Testlab will create a transparent overview plan for you, in which all costs for approval in the individual countries can be seen and the time planning is tailored to your needs. You will also receive an overview of which test samples are required when, and when and where additional documents must be submitted in order to meet the schedule.

Depending on the scope and complexity of your approvals, a project can take anywhere from a few weeks to about a year. This usually involves several sub-projects, i.e. the approval may already have been completed for one country, while it is still pending for another. This is particularly relevant if you want to sell your product to an OEM who requires you to obtain approval for all the necessary countries.

To help you plan for and estimate the time and expected cost of bringing your product to market, contact us at your earliest convenience.

As mentioned in the second part of the series, it is very important to think about the marketing of the product BEFORE development, not only for cost reasons.

This is because despite some regions having common test standards, the sticking points are often in the details. While the advantage of the European Economic area lies within it having uniform regulation for radio products in the form of RED (Radio Equipment Directive) or 2014/53/EU, it is important to note that country-specific regulations may also still apply.

Generally speaking, before a product is marketed in the EU the manufacturer must subject it to a conformity assessment procedure provided for in the applicable directive in order to be allowed to affix the CE marking.

For radio products, this is the RED, among others. However, the manufacturer also has the obligation to check whether other directives may apply.

In doing so, a manufacturer has the following tasks:

• perform the applicable conformity assessment or have it performed
• prepare the required technical documentation
• issue the EU declaration of conformity
• provide the product with instructions for use and safety information in a language easily understood by consumers and end users and determined by the Member State concerned
• mark the product with a type number, batch number, serial number or other mark for identification purposes
• affix the CE marking indicating the manufacturer's name, its registered trade name/brand and only contact address

The RED (2014/53/EU), also known as the Radio Equipment Directive, does not include specific test procedures. However, the so-called "essential requirements" for a radio product are formulated here, compliance with which is demonstrated using harmonized standards.

Using harmonized standards, the presumption principle then applies. It is therefore concluded that by applying harmonized standards listed in the Official Journal of the European Commission, a product complies with the essential requirements of the European Union. With regard to the RED, a CE mark may now be applied to the product, and thus marketing is permitted in the European Economic Area.

As a manufacturer or distributor, you must therefore declare which harmonized standards you have taken into account and applied to your product.

The RED applies to so-called radio equipment. But what is radio equipment? Well, according to the RED: “a radio installation is an electrical or electronic product that emits and/or receives radio waves for the intended purpose of radio communication and/or radio location, or an electrical or electronic product that requires accessories, such as an antenna, in order to emit and/or receive radio waves for the intended purpose of radio communication and/or radio location.”

There are a number of things to consider, especially when retrofitting radio modules into devices that have not previously fallen under the scope of the RED (e.g. washing machine, toothbrush, lighting...).

Think about what kind of product you have, what you want to do with it and what the intended use case for it (product determination) is.

A first step can be to write a risk assessment. In doing so, it is crucial to identify what potential hazards your product may pose with respect to the essential requirement (risk determination). Therefore, manufacturers must perform a risk assessment to first identify all possible risks of the product and determine the essential requirements that apply to the product in question. In the risk analysis, the hazards are qualified and then assessed.

We will explain what needs to be considered in a risk assessment according to RED in a later part of this series.

In certain cases, e.g. if a test standard is not listed in the Official Journal, a so-called Notified Body (formerly Notified Body) must be consulted, which then certifies conformity.

Phoenix Testlab has several Notified Bodies (e.g. for EMC and RED) and is happy to help you.

Overview of our Notified Bodies

In the previous articles we have written about what a radio product is in the first place, what influence the selection of countries can have on the end product and how the placing on the market in the EU is done. In this post, we address another critical issue: the integration of radio modules.

In many cases, a successful product is configured for modern communication requirements by integrating a radio module already available on the market into the device. Does it all sound simple? It is - if the following points are taken into account:

This is a clear misconception!

It is crucial to determine for which markets exactly the radio product has been approved and according to which standards. Do these coincide with your own markets and standards?

In any case, there are tests which must be  carried out in Europe for the end device with a focus on EMC and electrical safety. Furthermore, in Europe (RED) as well as for the USA (FCC) and Canada (ISED), integration measurements for the radio technologies are strongly recommended.

Just as with the complete measurement of a terminal device with wireless technologies, there are similarities in the requirements of the RED compared to the requirements of the FCC as well as the ISED for module integration. However, from a test engineering point of view, the test setups and measurement requirements differ so much that synergies do not occur in most cases.

Nevertheless, you can save costs if you choose a service provider, like Phoenix Testlab, who can offer the required tests from a single source. This often reduces the time required (you get your test reports faster) and you have less to coordinate (send test samples, arrange appointments, etc.).

There are a great variety of radio modules on the market.

In order  to make a suitable selection here, some familiarization is required. For example, it is not always advantageous to use the "all-rounder" if only a single radio technology is used.

There can be major hurdles here, especially for integration in devices for the US market. Furthermore, good contact with the module manufacturer must also be taken into account when making the selection, since various documents are required, e.g. for approval. An uncomplicated and cooperative communication will make the approval process much easier.

Last, but certainly not the least important points, are of course the price as well as the quality.

There are basically no mandatory documents required for the integration of a pre-qualified/certified radio module.

Nevertheless, it is advantageous for you to be able to request certain documents from the module manufacturer. For example, helpful documents include certification certificates, the DoC (Declaration of Conformity) and existing test reports.

Creating an approval strategy is an important item that you should do, if possible, during the development phase of your product. The following points can be determined:

• Country selection (in which countries do you want to market your product?)
• Technology (which technologies do you want to use or allow?)

From these two points, the next steps will follow. The combination of the desired countries and the used technology results in requirements that your product must comply with. The requirements are technical as well as administrative.

In the later stages of development it is often difficult to integrate requirements into a product.. You can avoid expensive re-designs if at an early stage, your development plan takes into account the requirements from the approval strategy.

The example of WLAN is a good illustration of the different technical requirements, because the permitted WLAN channels are not identical in some countries, and the permitted transmission powers also differ from country to country.

The following chart gives an overview for WLAN in three markets: the EU, USA and Japan.

Administrative requirements are usually easier to meet. They include the labelling of the products and/or the technical information listed within the manual, in addition to the requirements for the approval holder.

The marketing authorization holder may not always be a company e.g. from Germany. Often a marketing authorization holder/importer of the product in the country where you want to market is needed. Sometimes special contracts between companies in the country of registration and the company in Germany must be proven. Russia has very restrictive requirements for this contract. In some other countries like China, South-Korea or the USA, a registration of the German company in a national database must be completed before the registration can be done.

In addition, some countries such as Brazil, Mexico or Taiwan require test samples for in-country testing. Shipping and in-country testing require good documentation of the test samples. In these circumstances tests are often performed by a purchased module. Therefore, the support of the module manufacturer is necessary. This documentation requires a time effort that should not be neglected.

Please consider this already when choosing your module manufacturer.

The number of available test samples determines whether several country approvals can be performed in parallel or whether they can be performed serially. A serial approval takes correspondingly longer, furthermore the transport risk and the logistical effort for the timely testing in the individual countries increases.

If you want to approve your product in several countries, it is best to plan a few more test samples in order not to lose too much time.

The number of test samples depends primarily on how much time you have available for approval.

If you must meet strict time-to-market requirements, it is best to talk to our approval experts at an early stage - they will be able to draw up a plan showing the minimum number of test samples you need to meet this target.

This brings me to my last point, the time required and, of course, the cost you should budget for approval. Both are strongly dependent on the number of countries and the technologies used.

For a worldwide approval you can expect without problems a duration of at least half a year (if everything goes well) up to one year. The complexity of the product has an additional influence here besides the number of countries.

The costs for a radio approval depend mainly in the first step on the number of countries and of course on the necessary type of approval in the desired countries. This means, for example, whether you must have your radio tested in the country of registration or not.

In addition to the number of countries, the complexity of your product is also decisive here. The costs for the approval of an RFID reader in some countries are extremely different from the costs of a smartphone with Cellular (2G, 3G, 4G, 5G), WLAN (2.4 GHz + WLAN 5/6 GHz), RFID, Wireless Charging, ...

Therefore, create an approval strategy as early as possible in the development phase. Professional service providers like Phoenix Testlab can help you with this.

An approval is a permit issued by an authority that allows a product - in this case a radio product - to enter a specific market (country or economic area). It must be applied for in advance and is usually associated with specific requirements, deadlines, and costs.

The product may not be sold without approval for the relevant market.

Even if the approval itself is only completed at the very end, i.e. after the actual tests, it is nevertheless a topic that you should deal with at the very beginning.

Product development sometimes takes several months. Why is it always recommended to think about approval at the very beginning? After all, doesn’t it only become relevant when the product is already ready?

Answer: Because approvals have a decisive influence on the overall costs and, above all, on the market launch date, including all the associated activities (logistics, production, marketing, sales). Requirements of individual countries may differ and thus already have an influence on the selection of components and modules or how the firmware needs to be programmed.

The more informed you are about the individual requirements, times and costs of approval for the desired markets for your product, the better you can plan and avoid problems during the market launch. A professional service provider can advise you here at an early stage and transparently develop an approval strategy that is right for you. Do not underestimate the effort involved! Especially in the case of approvals for several countries, professional advice is money well spent.

Documents do not have to be submitted to an authority or its representatives in every case. Nevertheless, you should have the appropriate documents ready in case there are inquiries from the authorities.

In addition to the test reports issued by the testing laboratory, many other documents must usually be provided in order to obtain approval for the product.

However, which documents these are depends on the requirements of the respective countries. Typical documents are e.g.

• - test reports from a recognized laboratory
• - block diagrams
• - parts lists
• - circuit diagrams
• - instruction manuals
• - internal and external photos of the device
• - etc.

This question only arises when you have all the necessary documents together. If you work with a professional service provider, they will monitor the deadlines and take care of providing the documents to the relevant contacts for you. The more important question, therefore, is where you will get these required documents and which ones you will have to prepare yourself.

Obtaining the required documents can sometimes be quite time-consuming and, as mentioned earlier, should be tackled at the very beginning of the project. This will ensure that you can meet the deadlines for placing the product on the market. If you are integrating radio modules, for example, you cannot prepare all the documents yourself because they must be provided by your supplier Ideally, you should clarify this during the development of your product.

Once all the required documents are together, the data package is then sent to the appropriate body, e.g. Notified Body (RED), TCB (FCC), FCB (ISED), RCB (MIC), the authority directly, or even an agent or service provider. To avoid unnecessary queries, the documentation provided should be in accordance with the respective requirements.

It is good to seek professional assistance at this point, as requirements and contacts are always changing. If you do not have the time and capacity to take care of these matters yourself, take advantage of the knowledge of experts who specialize in this area.

Phoenix Testlab has assembled an experienced team for this purpose, which can handle your approvals for you. We are in worldwide contact with authorities, representatives, and agents to obtain the approval of your radio product as efficiently as possible. As part of an approval management system, we take care of providing the documents, meeting the deadlines, and communicating with the approval authorities. You can transparently track the progress of the project at any time and always retain full project and cost control. Just get in touch with us, we will be happy to help!

Finally done! Your radio product has been approved and sales can begin in the appropriate markets. Congratulations!

The biggest hurdle has been cleared! However, approval management is necessary for the complete life cycle of your product even after the approval has been completed. Often this effort is underestimated or not even considered.

Apart from additional sales markets for which a new approval may be necessary, you can distinguish between two points in an approval management:

• You have a product change
• There are no changes to your product

Many products are adapted, expanded, changed, or relaunched in variations over time. Sometimes new user groups are addressed, or the application area is extended.

Does this also apply to your products?

Please note: Product changes can sometimes have a major impact on your approval. We are not only talking about changes to the hardware, but also changes to the software or even in the use of the device.

Changes to the software or firmware are often elementary – nonetheless an influence on the granted approval must be evaluated.

For example, a change to the software to correct a spelling error in the web interface is certainly negligible. On the other hand, a change to the power table of the device may mean a new approval if the new values mean a higher output power.

Adding a graphical display to the device's user interface may either have no impact or even cause your device to become non-compliant.

If you are unsure about the impact of software changes you plan to make on approval, please seek professional advice.

In addition to software changes, hardware changes are not uncommon in the life cycle of a device. Such changes include:

- A new antenna because the old version is no longer available

- Component changes (PIN compatible) because a component is no longer available

- Changes because a new component is not PIN compatible

The Federal Communications Commission (FCC) provides guidance for the US market in FCC KDB 178919 on how to deal with such changes from their perspective. A similar approach must be taken in all other countries around the world. Therefore, do not hesitate to seek expert advice when making changes to your product!

Changes in usage, where the hardware or software remains the same, are often neglected.

Example: product marketing finds a new use for the device. Specifically, their product is no longer marketed for industrial use only, but is now to be used for home use as well. Or the marketing channel of your product changes.

The application area in the home area leads to limit values that differ from the limit values in the industrial area. Without this consideration, a change in use is not possible. Furthermore, a use for the home area can also lead to adaptations of the instructions for use and the risk assessment.

Do not take this lightly - changes in use can be very expensive without adapted approval: ban on marketing by market regulator, loss of insurance coverage, liability for misuse, etc.

But even in the case of products without changes, a regular check for current requirements is advisable.

Here is the example in the European area, where it must be checked again and again whether the current requirements are met. New standards like the ETSI EN 300 328 partly bring new requirements to your product. In addition to the standards, the directive also brings new requirements, such as cybersecurity.

A good service provider will inform you about relevant changes in the requirements in time.

Admissions are usually not perpetual but must be renewed from time to time. It is your responsibility to take care of this in good time.

If the validity of your approval expires, your product may also no longer be sold on the market.

This can become a very time-consuming task once you have a larger product portfolio and/or sell to multiple countries.

Phoenix Testlab's International Type Approval team closely monitors the validity of our customers' products. You can be assured that you will be informed of expiry dates in a timely manner and that further action, such as approval renewal, will be coordinated with you.

Yes, they are.
When it comes to radio product approval, technically speaking, the FCC and ISED have a lot in common. Unfortunately, there are also differences - and they are in the details. In some cases, the editions of the referenced test standards differ. There are also differences in the frequency ranges and output power values to be used.

Therefore, do not make the mistake of equating FCC and ISED. In addition to the differences in technical requirements mentioned above, there are also some differences in the type of approval. With Phoenix Testlab as your partner, you have significant advantages: Due to the close cooperation between our accredited laboratory and the Notified Bodies, your radio approval for the markets EU, USA, Canada and Japan can be achieved from one source. For you, this means: less coordination and organization effort and the security of test reports from a service provider with an international reputation.

We would be happy to discuss this with you in a personal meeting.

"There's no difference", "You can test that together"... these are just two of the statements we often hear. Unfortunately, this is not correct.

If for the FCC and ISED "only" the frequency ranges and output power limits differ, the difference to the RED compliant test here is also the test setup. While, for example, the radio tests for FCC and ISED are performed at different table heights, the table height for RED-compliant tests is the same. Furthermore, the receiver is also tested during the radio tests for the European market, which is not taken into account during tests for FCC or ISED.

There are lots of other differences in testing and certification  it is easy to get confused so please don’t hesitate to contact us.

Besides the many countries that accept either the test reports according to European standards or US-American standards, there are some countries (e.g. China, Brazil) where this is not sufficient for an approval. In some cases, these countries require their own standards. Testing in one of the laboratories of the respective country (InCountry) is also mandatory.

In order to be able to obtain approval in the respective countries, it is necessary to establish and maintain a network of contacts. Phoenix Testlab has a team for this very purpose, which is called ITA (International Type Approval). This team coordinates all necessary tests and approvals for you in the respective countries, takes care of the communication with agents and authorities and ensures that all necessary documents are submitted on time.

In principle, only one test specimen is required for the tests of the radio technologies. However, it should be noted that several samples enable the laboratory to react quickly in case of failure of a DUT (which unfortunately does happen from time to time). Furthermore, tests can often be performed at the same time, which can significantly speed up the test plan. This reduces costs for you and ensures faster results.

Radio tests, especially according to RED, also require EMC and safety tests, for which several samples are needed in any case.

Recommendations from our side:

• 2 samples for the radio tests
• 2 samples for the EMC tests
• 2 samples for the safety tests
• 1 unsealed open sample for the documentation

As a basis for the start of a smooth process, a lot of information is already useful for the preparation of the offer. The more information you have clarified at an early stage, the easier it is to carry out checks in order to avoid future errors.

The following information is already very helpful when preparing the quotation:

• Model designation of the DUT (final, meaningful, unambiguous)
• Data sheets of the DUT and radio modules used
• Information about external cables, electrical ports and power supply
• Temperature range
• Maximum power consumption
• Dimensions and weight of the DUT
• Details on the radio technologies used
  • Frequencies/frequency ranges
  • Transmit power
  • Data rates
  • Modulations
  • Bands

Don't let yourself get carried away! Most errors are caused by time pressure, lack of information and poor preparation. Therefore, take your time and calmly do a few quality checks before the test date - it's worth it!

Preparation of the tests:

• Good preparation of documents, equipment and especially commissioning are advisable
• The test item should have the final status, since later changes would otherwise have to be addressed in the risk assessment and retests may be necessary
• Tests on prototypes during development are also advisable
• DUT designations and specifications must be consistent in all documents (data sheet, manual, etc.)

Commissioning of the setup in advance

• Do all operating states and test modes work?
• Check of the monitoring
• Error simulation
• Function of the monitoring software
• Have the description of the test setups and the operation checked, e.g. by a colleague

Recommendation: Supply additional test items, e.g.

• in case test items fail
• to be able to detect defects or device errors
• to be able to reproduce results

We hope that these tips will help you and already provide guidance for your next tests. Certainly not everything can be answered in detail here, so the following applies: talk to us, get advice and don't be afraid to ask questions. Our account managers have a lot of experience with the different requirements and technologies and will be happy to answer your questions by mail, phone or chat. We look forward to hearing from you!

Cybersecurity is a topic that we encounter more and more in everyday life. Whether cyber-attacks on counties in Germany or oil pipelines in the USA; presidents of world powers accusing each other of cyber-attacks or ransom demands after hacker attacks - who is not familiar with these reports?

New regulatory requirements for cyber security of products are currently emerging in many countries around the world. In Europe, too, work is being done on these new product requirements. The European Commission wants to proceed in two steps to ensure full coverage of cybersecurity in all networked products:

The European Radio Equipment Directive 2014/53/EU (RED) will, after a short transition period, cover internet-connected radio equipment as well as radio components, such as radio modules, on cybersecurity. This also affects products in which radio interfaces have been integrated.

The aim is to ensure that privacy, networks and fraud protection is guaranteed.

A general, horizontal legislation on cybersecurity of Information and Communication Technologies (ICT) products, which will then affect all remaining wireless and wired products connected to the network. These requirements will regulate all remaining cybersecurity risks for availability, integrity and confidentiality.

This second step has also already been launched.

The mark-up for the new cybersecurity requirements for products covered by the Radio Equipment Directive has already been made. The European Commission published a delegated act (Delegated Regulation (EU) 2022/30) in January 2022, which assigns specific requirements of the RED to certain radio equipment. This means new tasks for manufacturers, test laboratories, notified bodies and market surveillance authorities.

1. The requirements for network protection apply to any radio equipment that can itself communicate via the Internet, regardless of whether it communicates directly or via other equipment.

2. The requirements for the protection of personal data and the privacy of users and subscribers apply, with few exceptions, to the following radio equipment:

    

   (a) radio equipment connected to the Internet, unless specified in points (b), (c) or (d);

   (b) radio equipment designed or intended exclusively for childcare purposes

   (c) radio equipment, as defined in the Toy Safety Directive (smart toys);

   d) wearables (smartwatches, fitness trackers, etc.).

3.  

   The anti-fraud requirements apply to any radio device connected to the Internet if that device enables the owner or user to transfer money, monetary values or virtual currencies

    

After a transition period, the new requirements will become mandatory for affected products on 1 August 2024. This is a very short time, because new standards must now be developed and products must then be upgraded according to these standard requirements. In principle, manufacturers can choose between two procedures: self-assessment with the help of harmonised standards or, if these are not yet available for the product in time, conformity assessment by a Notified Body.

In any case, a point in time has already been reached today: to familiarise oneself as a manufacturer with the topic of cybersecurity!

Status: April 2022

Holger Bentje ist Head of Radio & Telecommunication Department bei Phoenix Testlab und Chairman der RED CA (Radio Equipment Directive Compliance Association).