Division 2.3 Quality system
United Kingdom
- 2.3.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.
- 2.3.2The quality system shall ensure that the instruments are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them.
- 2.3.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 2.3.2.
- 2.3.4Division 2.3.4
- 2.3.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.