Introducing a physical product to the market is a complicated process. Problems related to the project start at the very beginning: gathering the right team or creating a functional prototype can be challenging. In the end though - there comes a time to bring this new product to life. At this point most companies face a problem they had not thought about before - a product compliance with the law and applicable standards.
Each product must meet the appropriate standards that guarantee that it's safe to use and has the ability to cooperate with other devices without interference. In Europe, these norms (or rather - directives) are set by the European Union. Depending on the device's type, it must meet the goals of the directive adapted to it. Due to the fact that most products created by startups have radio communication (e.g. WiFi) we will describe a directive that is suitable for this type of devices - 2014/53/EU - that is RED (Radio Equipment Directive).
It is a relatively new document, that replaces previous regulations (1999/5/EC - R&TTE and others) and applies to all radio devices. It was enacted on February 26, 2014, but it did not take effect immediately - it is a result (among other things) of the fact that it does not replace one specific document, but several ones. It also changes the approach to device certification. To better understand this - let us first take a look at how such normalization documents are created and how it looks from the legal side.
Basics of directive's law
There are two main types of legal documents in the European Union - the Regulations and the Directives. The Regulations are acts of the highest rank. They must be respected throughout the Union and do not have to be included in the legal order of specific countries for this purpose. An example of a Regulation is the GDPR - that is why companies had to comply with it, even though in some countries local legislation did not keep up with the EU changes.
Directives - on the other hand, are acts that focus on the objective (eg ensuring security or environmental protection), which must be achieved by all Member States. In contrast to the Regulations, they must be incorporated into the local law of each country to be applied. Their main goal is to ensure the consistency of regulations regarding a trade in goods throughout the Union. This is to ensure the free market in EU, which is one of the assumptions of the community.
Currently directives consist of general orders, they distinguish the Essential Requirements that a product must meet, that is - results (e.g. energy usage) that must be achieved or hazards that must be avoided. The Essential Requirements do not contain detailed technical specifications, nor specify the manner in which the manufacturer has to meet them. For this reason, the manufacturer can propose different solutions to achieve the directive's objectives.
However, such freedom may be more problematic than helpful. Questions arise - for example, what specific level of electromagnetic emission is safe for people? That is why the so-called Harmonized Standards were prepared for Directives. These are, simply speaking, technical specifications - the fulfillment of which guarantees a product compliance with the corresponding Essential Requirements. It should be remembered though that the use of standards is voluntary - however it is the safest solution, as it protects against undermining product's compliance with the requirements of the Directive.
Back to RED
Once we know the legal basis, it's time to return to the document we are interested in - the RED. As mentioned, it concerns radio devices - but not all of them. What's excluded?
- military equipment and used in the area of public security
- equipment for radio amateurs
- equipment for aircraft and ships
- prototype devices (according to an individual project) used in research and development centers
The requirements resulting from the RED directive do not have to be met by prototypes shown at various startup meetings and conferences. You do not have to worry about the directive if you're at the stage of constructing a working prototype, to show at a workshop. The only caveat is that the device can not be marked with the CE sign and must have information that it is a presentation model - not for sale.
So what is its scope? Virtually all radio devices (operating on frequencies up to 3000 GHz), which are not excluded from it.
What's the difference between the RED and the documents that were previously applicable (eg the previously mentioned R&TTE)? There are several, let's discuss it briefly!
- in accordance with RED, a whole device must be certified, not its essential (radio) component - this causes that the GSM module with the CE mark (meaning compliance with the directive) placed in the device does not make the new device automatically meet the RED assumptions in terms of emitting radio signals. Combining two previously certified devices into a new one does not make it RED compliant.
- earlier if the device (e.g. oven) had radio communication, it had to meet the assumptions of different directives - separate ones for the safety of electrical devices (eg LVD and EMCD Directives) and a separate one related to the radio emission. Currently if the device has radio communication, only the RED directive applies (this does not exclude the usage of additional documents - e.g. for toys)
- RED tightens many safety requirements in comparison with previously applicable directives, introduces more precise definitions
However there is one problem - what to do with machines that have radio communication only as an option? For example, a vending machine that has an option of attaching an adapter that provides a GSM communication - which standard should be used in this case?
The Radio Directive also regulates this issue. Simply speaking - if it's possible to separate the radio part as a separate module, two approaches are possible:
- certification of the entire device in accordance with the RED’s standards
- certification of non-radio parts in accordance with other standards, and radio ones in accordance with RED. However, we must be sure that connecting a radio transmitter will not cause effects that disrupt the device's operation and make it incompatible with the relevant directives - the first approach is therefore recommended.
Who is responsible for meeting the standards?
Since we already know which devices are covered by Directive 2014/53/EU, the question remains who is responsible for ensuring that devices on the market meet directive’s assumptions. The simplest answer would be: everyone but the end customer. But as you can certainly guess - it's not a simple issue.
Introducing a product to the market bears the greatest responsibility. It should have all test reports that confirm the product's compliance with the Harmonized Standards or with the Essential Requirements. The entity should also ensure that the device is properly marked and contains the required documents (mainly instructions and a declaration of compliance). It's also necessary to store documentation, mark devices with serial number and it’s still not the full list.
Each Member State can take steps to prevent the trade of non-compliant devices, so its fulfillment is so important - if we do not want unpleasant consequences.
Distributors also have their responsibilities. The most important ones are:
- checking if the producer (or importer) reliably declares that he meets the RED assumptions
- control whether the product has all the necessary markings (the product must also include the importer's data if there is one)
- checking the presence of instructions (and in the case of imported device also if the translation of relevant documents is prepared and included)
An important remark for companies that outsource the production of equipment abroad, to sell them under their own brand - in this case the owner of the brand is considered producer - not real production facility.
The above article does not cover all the aspects of the certification process and the issue of the standards and directives themselves. I hope that it gave a glimpse into the subject and suggested where to look for further information.
As you can see the certification process for the device, finding the right standards and ensuring a compliance with them is a difficult matter.
If you want to prepare your product for entering the market but need an advice and consultancy services - contact the Summer Agency team.
Published by: admin in blog