The notified body that issued the design or type-examination CE marks regarding specific medical devices or products must approve any substantial changes to those same devices and products.
To help you determine if the changes made require assessment, LNE/G-MED published a Guide on the interpretation of substantial changes, based on the European NBOG’s Best Practice Guide “Guidance for manufacturers and Notified Bodies on reporting design changes and changes of quality system”.
During the webinar we will present the key features of the above-mentioned Guide:
- Regulatory framework
- Defining substantial changes
- Changes to design
- Changes to materials
- Changes of the sterilization process
- Changes to software
- Changes to labeling
- Changes to the manufacturing processes
- Changes to drug delivery devices