1. Annex IV—Determine if equipment falls under it.

2. Equipment does not fall under Annex IV—Create a Hazard Analysis and Technical Construction file (TCF), as required per Annex V.

3. Declaration of Conformity—Create an Annex IIA Declaration of Conformity and have it signed by the manufacturer or their EU representative.

4. Affix the CE mark.

Path II

1. Annex IV—Determine if equipment falls under it.

2. Equipment does fall under Annex IV—Were harmonized norms used when designing, testing, and manufacturing the equipment?

3. Harmonized norms were not observed—Submit product to EU notified body for EC-type examination. Upon successful completion, the notified body issues an EC-type examination certificate.

4. Declaration of Conformity—Create an Annex IIA Declaration of Conformity and have it signed by the manufacturer or their EU representative.

5. Affix the CE mark.

Path III

1. Annex IV—Determine if equipment falls under it.

2. Equipment does fall under Annex IV—Were harmonized norms used when designing, testing, and manufacturing the equipment?

3. Harmonized norms were observed—either

·         Submit the product to EU notified body for EC-type examination. Upon successful completion, the notified body issues EC-type examination certificate.

·         Manufacturer creates the Hazard Analysis and TCF required per Annex V and forwards it to a notified body that will acknowledge receipt of the file and retain it.

·         Manufacturer creates the Hazard Analysis and TCF required per Annex V and forwards it to a notified body that will simply verify that harmonized norms have been correctly applied and will issue a certificate of adequacy for the file.

4. Declaration of Conformity—Create an Annex II Declaration of Conformity and have it signed by the manufacturer or their EU representative.

5. Affix the CE mark.