Design Documents in Technical File

Design Documents in Technical File

The medical device design documents are very important in the Technical documentation for the CE marking. The medical device description should contain the details of the design including its pictures and schematics depicting each design features of the medical device. For example, some of the design features include the coating on the medical device which has a specific intended purpose.

The design and development plan, Design input file, Design output file, design verification, design validation, design change reports are the basic documents related to the design that can be presented in the Technical File. The compliance to each design features should be demonstrated through testing, verification and validation. If any change in that, an appropriate rationale should be provided.

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If the design activities of a medical device are subcontracted to some other manufacturer what are required documents to be presented for the technical documentation for CE marking? Are all the design documents mandatory for all classes of medical devices in CE marking as per MDR?