EU MDR Clinical Documentation Kit

EU MDR Clinical Documentation Kit — Complete Bundle

Audit-ready clinical and post-market documentation for Regulation (EU) 2017/745. 8 professionally drafted Word templates covering the full clinical lifecycle: from Clinical Evaluation Plan to PSUR.

Whats included

• Clinical Evaluation Plan (CEP) — Article 61 + Annex XIV-A. PICO framework, equivalence criteria, state-of-the-art search protocol, GSPR mapping.
• Clinical Evaluation Report (CER) — Article 61 + Annex XIV-A. Executive summary, preclinical evidence, GSPR conformity, benefit-risk analysis.
• Clinical Development Plan (CDP) — Annex XIV-A. Residual uncertainties, GSPR cluster status, planned investigations, registry/RWD strategy.
• Post-Market Surveillance Plan — Article 83-84 + Annex III §1.1. Proactive/reactive inputs, indicators, vigilance, FSCA, trend reporting.
• Periodic Safety Update Report (PSUR) — Article 86. Production volume, status of previous PSUR actions, risk-benefit analysis.
• PMCF Plan — Article 61(11) + Annex XIV-B. Activity programme, method justification, acceptance criteria, threshold triggers.
• PMCF Evaluation Report — Annex XIV-B. Activities executed vs planned, integrated analysis, impact on benefit-risk.
• SSCP — Article 32. Professional and lay sections for Class III and implantable devices, ready for Eudamed publication.

Aligned with

EU MDR (Regulation 2017/745) Articles 32, 61, 83-86 and Annexes III, XIV-A, XIV-B. References to MDCG 2019-9, 2020-1, 2020-5, 2020-6, 2020-7, 2020-8, 2020-13, 2022-21, 2024-10.

Format and delivery

8 Word .docx templates + 1 Excel Master Index + README. Delivered as a single ZIP with organised folder structure (224 KB). Instant download after purchase. Lifetime access to updates.

License

Single-organisation license. Internal use across multiple device families and projects. Redistribution outside the organisation is not permitted.