Path to EU Market Entry
There are two potential paths that a manufacturer may elect to follow before making their products available on the EU Market.
Conformity Assessment Procedure
- Internal Production Control
2. Conformity to type based on internal production control + EU-type Examination (Annex III)
It must be prepared by the manufacturer and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall be drafted up according to the conformity assessment procedure followed by the manufacturer.
Essential requirements for all equipment
Equipment shall be so designed and manufactured as to ensure that:
- The electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
- It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.
Specific requirements for fixed installations
Fixed installations shall be installed applying good engineering practices and respecting the information on the intended use of its components.
- The Directive: EMC 2014/30/EU
- Authorized Representative
- Post-Market Surveillance
- Risks of Non-Compliance
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