Reassurance that Your Product Conforms with the EMC Directive
Notified Body Assessment
York EMC Services has successfully operated as a Department for Business Innovation and Skills (BIS) appointed Notified Body under the UK EMC Regulations (SI 2006 No.3418) for the assessment of EMC Technical Documentation under Directive 2004/108/EC.
As of 20th April 2016, Directive 2014/30/EU replaced 2004/108/EC and all existing Notified Body appointments were ended. York EMC Services has been appointed as Notified Body 2636 under Annex III of 2014/30/EU, following the Secretary of State’s acceptance of a recommendation by UKAS.
The EMC Directive allows third-party assessment of Technical Documentation in the form of a Notified Body Assessment. This provides an examination of the Technical Documentation by an independent EMC expert to determine whether the apparatus covered fully conforms to the essential requirements of the EMC Directive (2014/30/EU).
There are a number of reasons why a manufacturer may wish to obtain a Notified Body assessment:
- Apparatus is not fully covered by harmonised standards
- A standard cannot be fully applied, for instance due the size of the apparatus
- The intended environment is different to that covered by standards
- The sector is highly regulated and/or risk-averse (e.g. rail, nuclear, oil & gas) and a Notified Body assessment is a contractual requirement
- A manufacturer is uncertain about the validity of arguments made in his Technical Documentation
Under the requirements of 2014/30/EU, a Notified Body Assessment entails the manufacturer and the Notified Body entering into an on-going contractual agreement. Under this agreement, the manufacturer undertakes to inform the Notified Body of changes to the apparatus covered by the Technical Documentation and the Notified Body undertakes to keep the manufacturer informed of changes to the regulatory requirements such as Directives and Standards. The purpose of this agreement is to ensure that the Technical Documentation remains up to date and support the conformity of the apparatus.
The EMC Directive requires that manufacturers carry out an EMC assessment of electrical/electronic products that fall within the scope of the Directive. The assessment is to demonstrate that the apparatus conforms to the EMC Directive’s essential requirements. However, correct application of harmonised standards fully covering the essential requirements of the Directive is equivalent to this assessment.
In some cases an extended justification may be required to demonstrate conformance of the apparatus. Examples include where the scope of a standard does not fully cover the operation or technology of the product or where a standard cannot be applied without the testing methodologies being adapted, for example because of the large physical size of the product.
Where additional justifications are required over and above standard’s requirements, then a manufacturer may seek a Notified Body assessment, which will provide an independent third party view of the justification and additional piece of mind.
Notified Body activities fall under ISO17020 and YES operates as a Type A inspection body in this regard, meaning that it conforms to stringent independence and impartiality requirements.
Contact us to discuss a requirement for a Notified Body assessment.
A training course on the The EMC Directive is also available and discusses the role of the Notified Body.
Regulatory Compliance Services and Products
PDF file giving an overview of YES's Products and Services
BIS stands for the Department for Business, Innvoation and Skills.