# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 3.4

Extent: E+W+S+N.I.

The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system.
The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2.
After the abovementioned information has been received the decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/V/division/3/division/3.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-V/division-3/division-3.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.