Technical Documentation

Unlike past MDD and AIMDD technical file requirements which were general in nature, the new MDR (Annexes II and III) provides more specific requirements for technical documentation. It also specifies that the technical file “shall be presented in a clear, organized, readily searchable, and unambiguous manner.”

Technical documentation should include:

• Device description and specifications
• Reference to previous and similar generations of the device
• Package labeling and instructions for use (in appropriate languages)
• Product design and manufacturing information (including listing of all supplier and contract manufacturer sites)
• General safety and performance requirements (Annex I)
• Benefit-risk analysis and risk management plan
• Product verification and validation
• Pre-clinical and clinical data (clinical evaluation report)
• Post-market surveillance plan and reports

Arena QMS Tip:

Supplier Approval Quality Template

Use the supplier approval template to create a list of your approved suppliers and the parts they provide. This approved supplier list (ASL) is automatically linked to your product record and shows the history of any changes that are made. The ASL can be easily exported and included with your technical file.

Arena QMS Tip:

Technical File Quality Template

When building the technical file for your medical device, use the technical file template to avoid starting from scratch. The template covers all the essential MDR requirements and can be customized to meet your needs. The technical file is automatically linked to your product record and shows the history of any changes that are made. The technical file can easily be exported for review by your notified body.