The new 2014/53/EU directive, of the European Parliament and of the Council, of the 16th of April 2014, defines the marketing rules for radio-electric equipment and replaces the 1999/5/ EC directive (named R & TTE : Radio and Telecommunication Terminal Equipment’s directive).
It was published in the Official Journal of the European Union on the 22th of May 2014.
It entered into force the 12th of June 2014, and will be mandatory on the 13th of June 2016.
It is also named RED directive (Radio Equipment Directive).
The RED directive concerns :
- Wireless radio-electric equipment and radio systems
- Devices whose objectives are radio-communication and radiolocation
- Radio receivers
- X-Ray devices receiving signals (as guiding satellites systems).
- Pets equipment ("Article 3: Essential requirements).
The new directive removes the minimum threshold for the frequency range, however, the maximum range remains 3000 GHz as defined by the R & TTE directive.
Radio-electric equipment’s manufacturers are impacted by the RDD directive :
- They will have to use universal chargers for mobile phones and other portable devices.
- Class II electric equipment will be exempted from the "Alert" notification and labeling.
- Radio equipment will have to be CE marked (on their packaging or in their instructions for use). The " examination type certificate " will replace the notified body assessment.
These new requirements for certification must be taken into account as soon as possible by connected medical devices manufacturers, to ensure their product’s compliance with the new directive requirements.
Equipment complying with the old directive (R & TTE) can be marketed until the 13th of June 2017.