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Notified Body Requirements

The requirement of a notified body to be involved in a conformity assessment is not always mandatory. In fact, for product groups/directives such as electromagnetic compatibility, low voltage, radio equipment, recreational craft and simple pressure vessels; notified bodies are not required to be involved. Independent and accredited test labs such as Keystone Compliance are able to work with the manufacturer directly to meet all of the requirements of a declaration of conformity. The notified body’s involvement is based on the product group and often times further described within the group based on the product classification or categorization. For specific information on the requirements of each product category, please visit the European Commission website at: https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en.

Included below is a brief summary of each product group and the required involvement of a notified body.

Product Groups:

Involvement of Notified Body:

Active implantable medical devices

Obligatory

Appliances burning gaseous fuels

Obligatory

Cableway installations designed to carry persons

Obligatory

Construction products

Depends on the product classification

Eco-design of energy related products

Determined by Implementing Measures

Electromagnetic compatibility

Not required

Equipment and protective systems intended for use potentially explosive atmospheres

Product-specific requirements

Explosives for civil uses

Obligatory

Hot-water boilers

Product-specific requirements

In vitro diagnostic medical devices

Yes for IVDs listed in Annex II

Lifts

Obligatory

Low voltage

Not required

Machinery

No for most products, Yes for 23 specific categories

Measuring Instruments

Manufacturer’s choice of assessment procedure

Medical devices

Class I is no, Classes II and III are yes

Noise emission in the environment

Yes except for one procedure

Non-automatic weighing instruments

Product-specific requirements

Personal protective equipment

Category I is no, Categories II and III are yes

Pressure equipment

Category I is no, Category II and higher is yes

Pyrotechnics

Obligatory

Radio equipment

Not required

Recreational craft

Not required

Restriction of Hazardous Substances in Electrical and Electronic Equipment

Depends on the product classification

Safety of toys

Manufacturer’s choice of assessment procedure

Simple pressure vessels

Not required

Keystone Compliance has helped manufacturers CE Mark thousands of products without the added time, cost and frustration often provided by notified bodies. Contact us to learn how to streamline the CE Mark process for your products.