Summary:

Describes the procedure for determining which changes to the Quality System and/or Product Design need further approval from the Notified Body prior to implementation. Intended to explain the strategy towards voluntary notification of changes that do not require further approval of the Notified Body but that are nevertheless notified because of their importance. Applies to all planned changes to approved Quality System and/or approved Product Design of a CE marked medical devices regulated by the Medical Device directive (93/42/EEC).

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 2-page procedure that was actually created and used in the Regulatory Affairs operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

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