Team-NB Best Practice for the Submission of TD under Annex II/II of IVDR
Members of Team NB have created this best practice guidance document after reviewing the submissions of similar documents by individual notified body members within Team NB. The objective is to establish a consolidated approach to the expectations of technical documentation submissions from manufacturers.
Key Takeaways:
🔹 Maintain up-to-date general administrative information and assigned UDIs in technical documentation.
🔹 Provide comprehensive device description, including variant table, intended users, patient population, and device classification rationale.
🔹 Supply legible labels, target countries, translation process, and CE marking-related marketing literature.
🔹 Offer detailed design and manufacturing information, including critical ingredients, system overview, and subcontractor control system.
🔹 Identify applicable GSPRs and demonstrate conformance.
🔹 Ensure clear interface between risk management and performance evaluation.
🔹 Include comprehensive verification, validation, and performance evaluation with clinical evidence justification7.
🔹 Describe methods and procedures for Post Market Performance Follow Up, and detail the PMPF plan if applicable.
🔹 Provide surveillance data and search terms used for incidents and field actions for Post Market Surveillance10.
🔗 Original Document : https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-IVDR-V1-20230225.docx
