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Guide on CE Marking: LNE/G-MED free guide
Home | Guides | Receive free CE Marking: Dealing with changes in medical devices

CE Marking - Free guide

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”.

Simply complete the information below. Please be sure to provide a valid email address, so we can send your FREE guide.

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