Radio Equipment Directive (RED)

The Radio Equipment Directive (RED), 2014/53/EU is a new Directive that will replace the long established Radio and Telecommunications Terminal Equipment Directive (R&TTE Directive), 1999/5/EU. 

Published in the Official Journal of the European Union (OJEU) in March 2014, the RED is in a 2 year transition period and comes into force on 13th June 2016. The Directive is written in the new Legislative Framework and will bring significant changes for Medical Device manufacturers.


Products that fall under the RED include:

  • Electrical or electronic products which intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination, or
  • Products that, when completed with an accessory such as an antanna, meet the above description
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What does the change mean for you?

For products within the scope of the R&TTE Directive that will remain in the scope of the RED:

Products placed on the market before 13 June 2016 must use the R&TTE directive.

Products placed on the market between 13 June 2016 and 12 June 2017 can use either the R&TTE directive or the RED.

Products placed on the market after 12 June 2017 must use the RED.

 

For more information about the differences between the R&TTE Directive and the RED, and whether you require a notified body, see our RED brochure.



Why choose BSI for your certification?

The BSI team has a broad range of industry and regulatory expertise, and has over 10 technical experts with radio equipment experience. BSI has supported clients through many regulatory transitions, and we have the expertise to support you with the change from the R&TTE Directive to the RED.

BSI has been designated under the RED to be a Notified Body under Annex IV, Full Quality Assurance. 

In addition, BSI is a full scope Notified Body for the Medical Device Directives, and an accredited ISO 13485 certification body.