Introduction
Under certain product safety Directives, some products must undergo Conformity Assessment with the aid of third parties known as Notified Bodies. Their role is to verify that the designer / manufacturer have produced a safe and complaint product.
Notified Bodies are independent organisations appointed and accredited by member states to undertake conformity assessment of products within their accreditation and competency on behalf of the Responsible Person.
What you should know?
For many products subject to product safety legislation the Responsible Person (the manufacturer or their authorised representative) can self certify a products' conformity with all Directives that apply. However, for certain products (eg specific higher risk machinery and gas appliances) the Responsible Person has to follow a different conformity assessment procedure that requires the direct involvement of an accredited Notified Body to verify independently the product's compliance, and in some cases the manufacturer's quality and manufacturing system.
Notified Bodies can only act within their areas of competence, that is for certain Directives and certain modules for conformity assessment. Each Notified Body has its own unique 4 digit identification number which should be quoted by the Responsible Person on any Declaration of Conformity when a Notified Body has been involved in the assessment of a product.
The Nando website publishes list of Notified Bodies by: 4-digit number, member state and Directive, and this includes the areas of competence (which Directives and in some cases which conformity assessment procedures) they currently have and are permitted to act as a conformity assessment body.
Accreditation of Notified Bodies
For an organisation to act as a Notified Body it must be appointed and accredited by the member state in which it is located. Accreditation will be confined to specific areas of competence. These will be limited to certain Directives and may also only include certain conformity assessment procedures, otherwise known as modules:
- United Kingdom Accreditation Services (UKAS) website
- Accreditation Regulations 2009 - legislation.gov.uk
What does the Notified Body do for the responsible person?
They provide an independent assessment of a product against all of the essential requirements of the Directives, and the standards used in the design, for which as Notified Body they are competent and appointed to undertake. Notified Bodies will charge the Responsible Person for this service, which for some products may effectively be compulsory because of the conformity assessment provisions of the relevant product Directive.
In some cases (particularly for one-offs) manufacturers will submit an example of the product to the Notified Body for EC type-examination, along with a copy of the technical file, which must include the Instructions for Use.
In other cases, determined or permitted by the Directive applicable to the product, alterative procedures may be followed. For example the Machinery Directive permits a fill quality assurance conformity assessment route where a Notified Body must assess and audit the full quality assurance system for the design and manufacturing processes.
If the Notified Body accepts from the evidence placed before it that the product is compliant with the relevant Directive and if relevant standards (and where relevant, the manufacturing and quality system meets acceptable minimum standards for product assurance), they will then issue the Responsible Person with an EC Type-Examination Certificate. The Responsible Person should retain this, along with other relevant documentation (eg on the quality assurance system) as part their technical file and compliance assessment, and quote on the Declaration of Conformity the Notified Bodies' title, address and 4-digit code.
This information on the Declaration of Conformity will enable purchasers and market surveillance authorities to make enquiries on the validity of the Notified Body used, and in the case of market surveillance authorities, facilitate enquires into the validity of the Notified Body's assessment of the product.
Where a Notified Body has undertaken EC Type-examination a copy of the technical file will have to be provided to the Notified Body, and the Notified Body, as well as the manufacturer, should keep this (in the case of the Machinery Directive for 15 years from the date of issue of the EC Type-examination certificate).
Although most larger member states have several notified bodies within their territory, and manufacturers will often for convenience use one of their national Notified Bodies, they can choose to use any properly accredited Notified Body in any member state that is permitted to examine that particular product type. But they are not entitled to "play off" one Notified Body against another. In applying for assessment by a Notified Body the applicant must declare that an application for the same product has not been made to another Notified Body.
In circumstances where following assessment a Notified Body has not issued an EC Type-Examination Certificate the Notified Body is under a duty to communicate its decision and reasons to the applicant and share information with the appointing member state and other Notified Bodies. In the UK the applicant can appeal to the Secretary of State against a decision of a UK Notified Body not to issue an EC Type-examination certificate.
Some aspects of product safety Directives are unclear or ambiguous, and the European Commission via the Directive's advisory committee may approve a ruling drawn up by a committee of EU Notified Bodies, known as Recommendations for Use (RfU) and seek to aid consistency in the assessment and decision taking of Notified Bodies. Notified Bodies must take into account any relevant RfUs in making their assessment of submitted products.