Do I need a Notified Body?

Whether you need a Notified Body depends entirely on your product type and its risk classification under EU laws. Generally, you only need one for high-risk products (like medical devices, pressure equipment, or explosive-atmosphere equipment) to verify your CE Mark compliance.

If your product requires third-party validation, here is how to determine if your product requires intervention:

• Medical Devices & IVDs: If your device is Class IIa, IIb, or III, or an In-Vitro Diagnostic (IVD) of Class B, C, or D, you are legally required to use a Notified Body. Even Class I devices require one if they are sterile, have a measuring function, or are reusable surgical instruments. Low-risk (Class I non-sterile/non-measuring) can usually be self-certified.
• Industrial & Hazardous Equipment: Products like pressure equipment, gas appliances, lifts, and equipment used in explosive atmospheres (ATEX) generally require a Notified Body for CE marking.
• General Consumer Goods: For most standard machinery, electronics, and toys, you can usually perform the conformity assessment and self-declare CE compliance yourself, provided you maintain the correct technical files