As of June 13, 2017 all radio transmitters that are placed on the market in the European Union will have to comply with the new Radio Equipment Directive (RED) 2014/53/EU. This reality affects millions of devices destined for the EU.
The RED overhauls the requirements for radio transmitters and has caused a great many questions and discussion in the Conformity Assessment world. Here, we have compiled a short Q&A of Frequently-Asked-Questions around this topic. More discussion and development are underway in the EU with various industry groups, such as the RED Compliance Association (redca.eu), a great resource for the CA industry.
This piece offers a taste of the types of issues that are being raised in the industry as the June deadline looms. Here are just a few of Frequently-Asked-Questions regarding the RED:
Q. What is covered by the Radio Equipment Directive (RED)?
A. Essentially, all products that contain a radio transmitter that is used for communications must comply with the RED. Non-communicating radio transmitters must still comply with the EMC Directive.
Q. What radio equipment is NOT covered by the RED?
A. Annex I of the RED covers equipment that is NOT covered by the RED. In general, equipment intended by radio amateurs is exempt. In addition, marine equipment and airborne equipment.
Q. When is the RED required?
A. After June 12, 2017. Up until that time, both the RTTED and RED can be used. From June 13, 2017 and on, only the RED is allowed.
Q. What about products that use the RTTED?
A. From June 13, 2017, all products that are already physically in the market (in retail stores or in the supply chain that is not controlled by the manufacturer) can still be sold. Any product that is placed on the market after June 13, 2017, must comply with the RED.
Q. Can I electronically label my device under RED?
A. No. This is not allowed for RED or any other Directive. The European Commission is looking at this option, which is allowed in several other markets, but not in the EU. The concern is based around Market Surveillance and identifying a product without having to “turn it on.”
Labeling, however, is explicitly addressed in the RED, notably the following: “When placing radio equipment on the market, every importer should indicate on the radio equipment his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the radio equipment does not allow it. This includes cases where the importer would have to open the packaging in order to put his name and address on the radio equipment.”
Q. Do I place an NB Number on my device if I use a Notified Body?
A. Under RED, this is only allowed for devices that are approved under Full Quality Assurance (Annex IV of the RED). Truthfully, very few manufacturers use this route so the presence of the NB number will essentially vanish from labels. This frees up some space on ever-crowded labels, however the RED requires that more information on the responsible party be applied. (See the previous question).
Q. What standards should I apply?
A. You must apply the harmonized standards (HS) that are listed in the Official Journal to self-declare to the RED. One difficulty lies in the fact that there is not a complete list of harmonized standards in the Official Journal.1
Q. If HS are not accessible, how can I place a CE Marking on my product?
A. The RED allows for the use of a Notified Body (NB) to issue a EU-Type Examination Certificate (EU TEC). A manufacturer would submit an application for the EU TEC to a Notified Body who will evaluate the application for compliance with the RED. The NB would assess the device to available standards (harmonized and non-harmonized) for compliance. A NB can use standards that are in various stages of development, including draft standards and committee working drafts, if available. There is some risk that draft standards are subject to change. A NB should give guidance on the potential risk for any of the approaches that may be used.
Q. Who can apply for an EU TEC?
A. The manufacturer or its authorized representative can apply for the EU TEC.
Q. What Documents are necessary for issuance of an EU-Type Examination Certificate?
A. The following information is required:
- Application Form: Review and Certificate – RED
- External photos of the product
- Internal photos of the product
- User manual or instructions
- Technical operation description
- Block diagram
- Parts list
- Circuit schematic diagrams
- Tune up tolerances
- Product Safety test report
- RF Exposure test report
- EMC test report
- Radio test report
- Declaration of Conformity
- Risk assessment by manufacturer
- EFIS research evidence (for Class 2 devices)
- Justification and explanation letters, in cases where full use of harmonized standards has not been used, or if any deviations or partial testing has been included.
- Label
- Packaging (optional)
NOTE: EU-Type Examination Certificates will feature an expiration date. The period of validity is determined by the NB.
Q. What about scaled SAR?
A. “Scaled SAR” refers to the practice of adding transmitter tolerance to rated output power to determine SAR levels. This practice is referenced in Technical Guidance Note 20 (TGN20), however, this is only a guidance note and it is not mandatory to comply with scaled SAR. However, there is a risk that market authorities may test devices at a higher-than-rated output power.
Q. What about Risk Assessment?
A. A manufacturer must prepare a Risk Assessment. Some of the ways to perform a Risk Assessment is to review the application and use of the device, such as its installation location, environmental conditions and end-use. If there is a good track record of performance with little risk, the risk assessment can be fairly straightforward.
Q. Is an ISO 17025 accredited test report required?
A. No. The NB must be satisfied that the testing is being performed properly. Accreditation is not required for the testing lab.
Q. What additional tests are required under RED?
A. That depends. In many cases, you may have to perform some additional Receiver Tests if the new standard calls for the testing.
Q. What about EMC and LVD, are they still required:
A. Yes, the standards under EMC and LVD would be applied to satisfy EMC and Safety requirements for the Radio Device.
Q. What are the new reporting requirements for Notified Bodies (NBs)?
A. NBs must file copies of the EU TEC with their designating authority. NBs must also file EU TEC that provide negative results or for products that have been refused.
Q. Can you use HS that are harmonized under the EMC Directive for the RED?
A. Not directly. Although EMC standards may be harmonized under the EMC Directive, it does not automatically extend that status to the RED. The RED calls out meeting the essential requirements of the EMC and LVD; however, only the RED is cited on the Declaration of Conformity.
Endnotes
- https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte_en
