Path to EU Market Entry

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

  1. Internal Production Control

(Annex II)


2. Conformity to type based on internal production control + EU-type Examination (Annex III)

Technical Documentation

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.

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