Do we need a notified body for our product?

Whether a notified body is needed is decided by the act, not by the product type in general. Decision No 768/2008/EC sets the menu: where an act requires conformity assessment, the procedures are chosen from the modules in Annex II according to the type of product and the nature and degree of the risk, and where third-party involvement is mandatory the manufacturer should have a choice between quality assurance and product certification modules (Article 4(1)). In Module B, called EC-type examination in the Decision and EU-type examination in the acts aligned with it, "a notified body examines the technical design of a product" and attests that it meets the requirements (Annex II, Module B point 1). Where a notified body is involved in the production control phase, the CE marking is followed by its identification number (Annex I, Article R12(3)).^[5]

Some acts decide by category. The PPE Regulation (EU) 2016/425 sorts PPE into three risk categories in Annex I. Category I covers only minimal risks such as superficial mechanical injury and uses internal production control (module A). Category II uses EU type-examination (module B) followed by module C. Category III covers risks that may cause very serious consequences such as death or irreversible damage, including falling from a height and harmful noise, and uses module B plus module C2 or module D (Article 19). For category III the notified body's number follows the CE marking (Article 17(3)). The Pressure Equipment Directive 2014/68/EU classifies equipment in categories I to IV under Article 13. Category I uses module A; categories II to IV use the module combinations in Article 14(2), each of which involves a notified body (Annex III), from which the manufacturer chooses, and may also choose a procedure for a higher category (Article 14(3)).^[1][2]

Other acts decide by standards. Radio equipment may use internal production control for the essential requirements in Article 3(2) and (3) only where harmonised standards published in the Official Journal have been applied; where they have not been applied, have been applied only in part, or do not exist, the equipment goes to EU-type examination or full quality assurance (Directive 2014/53/EU Article 17(3) and (4)). Toys follow the same logic: internal production control requires harmonised standards covering all relevant safety requirements, and otherwise, where a standard is published with a restriction, or where the manufacturer considers that the toy's nature, design, construction or purpose requires third-party verification, the toy goes to EC-type examination by a notified body (Directive 2009/48/EC Article 19(2) and (3)).^[3][4]

Notified bodies are designated by Member States for specific acts. The Commission's guidance says they carry out conformity assessment tasks when a third party is required, that manufacturers are free to choose any notified body legally designated for the procedure, and that the Commission publishes the list in the NANDO database. If a product is placed on the market without the procedure its act requires, it does not conform, and authorities require corrective action and ensure withdrawal, recall or a prohibition when the operator does not act (Regulation (EU) 2019/1020 Article 16).^[7][6]