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EU Notified Bodies


Notified Bodies are organisations designated by the national governments of the member states as being competent to make independent judgments about whether or not a product complies with the protection (essential safety) requirements laid down by each CE marking directive. In order to be notified, the management structure of the organisation must fulfill certain conditions and the name of the body, along with the details of the scope of its notified activities, must be given ('notified') to the European Commission.

These bodies are also the organisations which will be requested to give judgment on the safety of a product by the enforcement authorities in the EU and therefore will be responsible for judging which standards should have been applied to a product and if they have been applied correctly.

For certain Directives (e.g. the EMC and TTE Directives) Notified Body is also the term used to refer to the government appointed agency which is responsible for registration of mandatory type approvals. Actual testing of products is not carried out by these agencies - the manufacturer should obtain a type examination certificate from one of the recognised test houses and submit this to the Notified Body in order for the product to be registered as having been type approved. Only then will it be possible to put the CE logo on the product and sell it throughout Europe. Under the Medical Devices Directive 'competent authority ' is the term used to refer to the government agency overseeing the regulatory regime (in the UK this is the Medical Devices Agency).

Not all Directives refer to the Notified Bodies as such - under the Machinery Directive they are referred to as 'Approved Bodies'. Under the EMC Directive, states can also notify 'Competent Bodies' whose job is not to assess products but to check the logic and justification of a claim of compliance with the Directive if the manufacturer opts to use a Technical Construction File.

Until recently, Member states could only notify bodies within their own territories and so the only bodies which were notified outside of the EEA were subsidiaries of EU resident organisations. However, under the Mutual Recognition Agreements ('MRAs') between the EU and America, Canada, Australia and New Zealand, regulatory authorities in these countries can, in effect, designate Notified Bodies within their own territory. Further MRAs with countries of the former Soviet Republic, Israel and Asian countries are expected in due course.

It is important to understand that MRAs can only be made for directives for which there is corresponding legislation in each party to the agreement. This means that the MRA will cover different product areas according to the states concerned. The following table gives the details. (NB: the table contains information on CE marking related MRA's only, and other agreements concerning non-CE marked products and services may also exist.)

 


MRA between the EU and

Products/directive covered

Australia


Automotive products
Electrical safety
Electromagnetic compatibility
Machinery safety
Medical devices
Pressure equipment
Recreational craft
Telecommunications equipment

 

Canada


Electrical safety
Electromagnetic compatibility
Medical devices
Recreational craft
Telecommunications equipment

 

Japan


Electrical safety
Telecommunications equipment

 

New Zealand


Automotive products
Electrical safety
Electromagnetic compatibility
Machinery safety
Medical devices
Pressure equipment
Recreational craft
Telecommunications equipment

 

United States of America


Electromagnetic compatibility
Recreational craft
Telecommunications equipment

 


Conformance Ltd specialises in consultancy and is not a notified body for any of the EU CE mark directives. The requirements for the management structure of Notified Bodies places certain restrictions on the way in which they can provide advice and assistance to clients whose products are being tested by them and we believe that we can offer a better and cheaper service to clients without these restrictions. Where necessary, we provide clients with recommendations on whom they should use as a Notified Body and while we have good working relationships with many, we do not have agency agreements with any. We believe that clients have a right to know that our recommendations are based on our understanding of their best interests, not on some undisclosed financial arrangement between ourselves and the Notified Body. Where we place business with Notified Bodies on behalf of clients, it is our practice to pass the Notified Body fees on at cost to the client, since we make our money by charging for our own expertise, not by selling other people's.

Lists of Notified Bodies are published in the Official Journal on an irregular basis. More usefully, the Commission have a section of their web site devoted to notified bodies and have recently established their NANDO web site which provides access to a database of notified bodies which can be searched by location and specialism.

The following is a (far from comprehensive) list of commercial Notified Bodies and test houses, categorised by the Directives under which they operate. Organisations marked with an asterisk (*) are not notified, but will perform tests to the relevant standards.

The presence or absence of any company on this list should not be taken to constitute any sort of endorsement (or otherwise) of that company by Conformance Ltd.

ATEX Directive

 

Automotive EMC Directive

 

Civil Uses Directive

  • The UK Explosives Notified body, Buxton, England

 

Construction Products Directive

 

EMC Directive

 

EMC - radio equipment type approval

 

Gas Appliances Directive

 

Hot Water Boiler Efficiency Directive

 

Lift Safety Directive

 

Low Voltage Directive

 

Machinery Directive

 

Medical Devices Directive

 

Noise Emission of Outdoor Equipment

 

Personal Protective Equipment Directive

 

Pressure Equipment Directive

 

R&TTE Directive

 

Recreational Craft Directive

 

Simple Pressure Vessels Directive

 

Toy Safety Directive

 

If you represent a Notified Body and would like your company details to be added here, please contact us giving the details of your company, the directives under which it is notified, and the address of your web site (if any).


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