Medical Devices complying with the Radio Equipment Directive

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/EC.

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.

BSI are working towards designation under RED to be a Notified Body under Annex IV, Full Quality Assurance.

For products within the scope of the R&TTE Directive and that will remain within 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 

​Read further detailed information about the Radio Equipment Directive.