What technical documentation and declaration records must the manufacturer keep?
Before placing the product on the market, the manufacturer must draw up technical documentation, carry out the applicable conformity assessment procedure or have it carried out, draw up the EU declaration of conformity once conformity is demonstrated, and affix the CE marking.
The manufacturer must keep the technical documentation and EU declaration of conformity for at least 10 years after placing the product on the market or for the support period, whichever is longer. Annex VII points the evidence set toward the product description, design and development information, production and vulnerability-handling information, the cybersecurity risk assessment, applied standards or specifications, conformity assessment material, and support-period determination.
Article 13(12)-(13), Article 28, Article 30, Article 32, and Annex VII cover documentation, declaration, conformity assessment, CE marking, and retention.
Section 6.6 explains technical documentation and section 6.8 covers the EU declaration of conformity.