Radio Equipment - Compliance Process
Path to EU Market Entry: Compliance
Conformity assessment Procedure
- Module A – INTERNAL PRODUCTION CONTROL ( Annex II)
- Module B and C – EU-TYPE EXAMINATION AND CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL ( Annex III)
- Module H – CONFORMITY BASED ON FULL QUALITY ASSURANCE ( Annex IV)
When the Harmonized standards are not applied in full the manufacture must follow the conformity assessment route set out in the Annex III or Annex IV.
In case of radio equipment affected by a low levels of compliance, a prior registration of radio equipment within specific categories is foreseen as measure to improve the market surveillance. By means of implementing acts the Commission will identify the categories of products that require registration and which documentation must be created in relation to them. It is anticipated that the central registry will be made available by the Commission from June 12, 2018 onward.
In the Radio Equipment Directive, two sorts of essential requirements are defined:
a) Essential requirements applicable to all radio equipment such as:
- Those covering all health and safety risks arising from the use of equipment, e.g. electrical, mechanical and chemical as well as (but not exclusively) health aspects relating to noise, vibration and ergonomic aspects as set out in the Directive 2014/34/EU.
- Those requirements assuring an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU.
- Those requirements assuring an efficient use of radio spectrum in order to avoid harmful interference as set out in the recital of the Directive 2014/53/2014
b) Essential requirements applicable only to certain types of radio equipment pursuant to specific legal acts adopted by the Commission (delegated acts)
The manufacturer puts together the technical documentation which makes it possible to assess whether the radio equipment complies with the requirements of the directive. It contains at least the elements set out in the Annex V.
- Radio Equipment Directive: an overview
- Radio Equipment - The Directive
- Radio Equipment Directive: scope
- Radio Equipment - Post Market Surveillance
- Radio Equipment - Authorized Representative
- Radio Equipment - Risks of Non-Compliance
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