The technical documentation constitutes the documented evidence of conformity with the General Safety & Performance Requirements (GSPRs) in Annex I of the EU MDR or IVDR. And, where applicable, any harmonized standards or Common Specifications followed as presumption of conformity. A suitable technical documentation must be complete, relevant for the concerned device models, and compliant with Annexes II and III of the EU MDR/IVDR.
Preparing a table of contents and templates out of these Annexes is straightforward but it does not suffice to compile a clear, organized and readily searchable technical documentation. Knowing what information is expected by Notified Bodies and competent authorities, and what level of detail provides sufficient evidence of conformity without requiring too frequent updates is far less easy.
Technical documentation is also expectation management.
Furthermore, many sections of the technical documentation are in fact the output of mandatory Quality Management System (QMS) processes, like risk management, clinical evaluation, or post-market surveillance (PMS). This means that the plans and reports compiled in the technical documentation must be aligned with the corresponding process described in a QMS procedure.
Because the technical documentation is a living set of documents, constantly evolving due to device changes, information gathered in the post-market phase, or regulatory change, maintenance can become cumbersome, and yield awfully patchy documents if not rooted in a systematic change management process. Inconsistencies across the technical documentation are usually the source of major non-conformities in Notified Body’s audits. Manufacturers should identify suitable technical writers and place efforts in ensuring a systematic approach throughout the different sections in the technical documentation.