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Summary of national notification system: UNITED KINGDOM
corresponding MEDDEV document.
• personnel Where possible, these requirements are set out in the Guidelines for designation which may be supplemented by UKAS working
documents.
• technical facilities Where possible, these requirements are set out in the Guidelines for designation which may be supplemented by UKAS working
documents.
2. Definition of scope of designation The scope of designation is defined in terms of the range of equipment to be covered and the modules. A notified body may be
appointed for a specific part of the scope of a directive and for specific modules.
• link to accreditation, if used Accreditation to the relevant EN45000 standard and for a relevant scope carries an element of presumption of conformity to the minimum
criteria for designation as set out in the relevant directive. However, accreditation needs to be supplemented by an assessment against
the directive-specific criteria
Conditions on subcontracted work and
activities of foreign subsidiaries?
Notified body groups
The quality manual of a notified body must contain procedures to ensure that subcontractors are suitable and a notified body must
maintain a register of all subcontractors and have documented procedures for their assessment and monitoring. A foreign subsidiary of
a UK notified body is treated as a subcontractor.
1. Requirement to participate? Yes, it is a condition of designation that notified bodies take part in co-ordination activities at both national and European level .
However, this does not mean that a notified body must attend every meeting of its respective group at national or European level.
2. Application of “recommendations for
use” from NBGs?
Standardisation
1. Requirement that NB participate or be
informed?
Notified bodies are encouraged to use ‘recommendations for use’ from NBGs.
Notified bodies are expected to be fully conversant with the latest applicable CEN and CENELEC standards and to be able to assess
products which are designed and manufactured to those standards. They are not required to take part directly in standardisation but
would be expected to maintain close contact with standardisation activities in their areas of designation and be aware of proposed
developments.
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