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Summary of national notification system: UNITED KINGDOM<br />
corresponding MEDDEV document.<br />
• personnel Where possible, these requirements are set out in the Guidelines for designation which may be supplemented by UKAS working<br />
documents.<br />
• technical facilities Where possible, these requirements are set out in the Guidelines for designation which may be supplemented by UKAS working<br />
documents.<br />
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<br />
appointed for a specific part of the scope of a directive and for specific modules.<br />
• 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<br />
criteria for designation as set out in the relevant directive. However, accreditation needs to be supplemented by an assessment against<br />
the directive-specific criteria<br />
Conditions on subcontracted work and<br />
activities of foreign subsidiaries?<br />
Notified body groups<br />
The quality manual of a notified body must contain procedures to ensure that subcontractors are suitable and a notified body must<br />
maintain a register of all subcontractors and have documented procedures for their assessment and monitoring. A foreign subsidiary of<br />
a UK notified body is treated as a subcontractor.<br />
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 .<br />
However, this does not mean that a notified body must attend every meeting of its respective group at national or European level.<br />
2. Application of “recommendations for<br />
use” from NBGs?<br />
Standardisation<br />
1. Requirement that NB participate or be<br />
informed?<br />
Notified bodies are encouraged to use ‘recommendations for use’ from NBGs.<br />
Notified bodies are expected to be fully conversant with the latest applicable CEN and CENELEC standards and to be able to assess<br />
products which are designed and manufactured to those standards. They are not required to take part directly in standardisation but<br />
would be expected to maintain close contact with standardisation activities in their areas of designation and be aware of proposed<br />
developments.<br />
3