Before production, you must determine which regulations apply to your product. Common frameworks include:

Risk assessments identifying potential hazards and how they are mitigated. 4. Drafting the Declaration of Conformity (DoC)

By signing this, the manufacturer takes full responsibility for the product's compliance. 5. Third-Party Assessment (Notified Bodies)

Product name/serial number, manufacturer's name and address, list of Directives and Standards used, and the signature of a responsible person.