Monday, December 12, 2016

5 Questions on the new Radio Equipment Directive 2014/53/EU (RED)

Coming into force on June 13, 2016, and half way through the transition period, the Radio Equipment Directive (RED) 2014/53/EU replaces the Radio and Telecommunications Terminal Equipment Directive (R&TTED)  1995/5/EC and over the past few months I've received numerous questions regarding the transition to the new directive. This isn't an all inclusive list or a full transition guide, far from it, I recommend that you consult a RED Notified Body with your specific needs for that. 

Here are the 5 most common questions I receive.

"Do I need to apply the new directive immediately?"
No, the RED came into force on June 13th 2016, however, article 48 gives a transitional provision accepting the old directive for radio equipment covered by the RED until June 12, 2017. That is to say you must apply the RED to covered radio equipment on or after June 13th 2017.

"Should I start testing to the new directive now?"
I get this a lot, and it's a very common misconception. One does not simply "test" to a Directive, you declare compliance to the Directive. 

The directive contains the essential requirements of compliance, among other laws, governing the "making available on the market" of Radio Equipment. Testing is one method for demonstrating compliance with the essential requirements, but the actual test methods are found outside the directive, referred to as "Harmonised Standards" under the directive. 

While in order to use a "Harmonised Standard" for presumption of conformity, it must be published with reference to the RED in the Official Journal, the new directive doesn't change harmonized standards, but it may impose new "essential" requirements that could impact your testing.

"Can I start "declaring" compliance to the new directive?"
Probably not. Article 17 of the RED describes the conformity assessment procedures. There are three annexes describing the available methods. (Annex II Internal Product Control) (Annex III EU-type examination) and (Annex IV Full Quality Assurance).

By far Internal Production Control is the most commonly used conformity assessment method and it's the only method that does not require 3rd party involvement of a Notified Body, but in order to apply Annex II, you must test in full to published harmonized standards. The problem is that the list of harmonized standards published under the new RED is small compared to the R&TTE. Chances are at the moment the particular harmonized standard previously applied has not been adapted and referenced to the RED, but the list is growing. See for links to the published harmonized standards.

Another issue here is that there is a change, however so slightly, in the requirements from the R&TTE article 3.2. This small change adds a new requirement to be assessed, and that is that the Radio Equipment "supports the efficient use of radio spectrum". New technical standards will need to incorporate this requirement.

"If I can't test in full to published harmonized standards, is there a method to comply with the RED now?"
Yes, there are a couple as mentioned above, Annex III EU-Type examination and Annex IV Full Quality Assurance. Of the two, EU type examination would generally be the most practical for most organisations that don't have the ability or wish to submit to a full quality assurance assessment or the continued surveillance required of that system.

EU-Type examination is a method by which the manufacturer submits an application to a "single" Notified Body of their choice. The Notified Body will review the technical design and verify the equipment complies with the essential requirements of the RED and if so issue an EU-Type examination certificate. This would be combined with the manufacturer's own assessment and the Declaration of Conformity (which will include the Notified Body number). The manufacturer would then affix the CE mark to the equipment (without including the Notified Body number)

 “If I test to the current harmonized standards for the R&TTE and write my declaration to the R&TTE now, what do I need to do June 13th, 2017?”
On or after June 13th 2017, all equipment that falls within the scope of the RED must be assessed to be in compliance with the RED prior to placing on the market in the European Union. This does not apply to equipment already on the market (sold or in the EU), only new shipments being placed on the market. The declaration of conformity must follow the new Model Structure and the manufacturer shall also establish the required technical documentation described in Article 21 of the RED. Also note that in addition to the technical test report the manufacturer is required to provide a risk assessment within their technical documentation.