Can the Technical file be electronic?

Yes, the Technical File can absolutely be kept in electronic format.

In fact, regulatory authorities in the US, Canada, and the EU actually prefer digital files because they are easier to share, update, and inspect.

Requirements for Electronic Files

• Easy Access: You must be able to open, read, and share the files immediately upon request.
• Clear Organization: Files should be well-structured (e.g., using PDFs) so authorities can find test reports easily.
• Secure Storage: You should use secure cloud storage or local servers with reliable backups.

Regional Acceptance

• EU: Authorities fully accept digital files. The EU “Responsible Person” can hold them electronically to send to market surveillance.
• US: The CPSC explicitly allows electronic General Certificates of Conformity (GCC) and digital lab test reports.
• Canada: Health Canada accepts electronic records as long as they can be easily viewed and printed during an inspection.