Classify your product
Default / Class I / Class II — your category determines the conformity assessment route.
Start by checking Annex III, which lists Class I (Important) and Class II (Critical) categories. If your product is on neither list, it is a default product.
Default products self-assess. Class I needs a notified body unless fully harmonised standards are applied. Class II always requires a notified body.
Document the classification decision and the reasoning. Market-surveillance authorities will ask.